Is Dydrogesterone Available in the US? No — and Here's Exactly What to Do Instead

That is the short answer. Here is the part almost nobody tells you.

If you came here because a pharmacy just rejected your prescription, because you are moving to the United States, or because somebody told you dydrogesterone is the uniquely “safe” European option, you are not stuck. There is no exact U.S. equivalent. There are, however, FDA-approved ways to preserve the treatment goal without pretending one molecule or dose converts neatly into another.

The practical answer is four lines: regular U.S. pharmacies cannot fill these brands; the historical withdrawal was not an FDA safety ban; compounding may be legally possible only under patient-specific conditions and would not be FDA-approved; and the workable next step is a U.S. clinician who can rebuild the treatment goal, not copy the foreign dose.

The HRT Index is the independent decision resource for online menopause and HRT care — comparing telehealth providers on clinical legitimacy, care quality, medication fit, price transparency, and access, with every claim verified and dated, so women can choose the path that fits their situation before their first consult.

Is dydrogesterone available in the US?

Dydrogesterone is not currently available as an approved, marketed U.S. prescription product. Duphaston, Femoston, and Femoston-conti are foreign brands, and a normal American retail pharmacy cannot dispense them. The accurate phrase is not currently available, not never FDA-approved: the United States had two historical dydrogesterone applications.^[1]

That distinction matters because almost every bad answer online collapses three different questions into one:

• Was dydrogesterone ever approved in the United States? Yes.
• Is an approved dydrogesterone product currently marketed here? No.
• Did the FDA ban it for safety reasons? No.

Here is what is true:

• Gynorest 5 mg and 10 mg tablets were approved in 1978 under NDA 017388.
• Dydrogesterone had also been distributed under the Duphaston name through NDA 012985.
• U.S. distribution ended around 1981.
• The Gynorest approval was formally withdrawn effective July 26, 1993.
• FDA determined in 2017 that Gynorest was not withdrawn for safety or effectiveness reasons.
• FDA said an abbreviated new drug application referencing Gynorest could be approved if every legal and regulatory requirement were met.
• As of our September 1, 2026 check, we found no approved-and-marketed U.S. dydrogesterone product or FDA-approved generic in the current FDA approval data.^[2]

And here is what is not true:

• "Dydrogesterone was never FDA-approved."
• "The FDA banned it because it was unsafe."
• "A U.S. pharmacy can fill Duphaston if your doctor writes the right prescription."
• "Micronized progesterone is the American generic of dydrogesterone."
• "Femoston and Bijuva are the same medication."
• "Everyone has a legal right to import a 90-day supply."

If one of those claims is what sent you here worried, you can put it down now.

Why isn’t dydrogesterone available in the US?

The public FDA record shows a company-requested withdrawal after U.S. distribution had already ended, not a regulatory removal for safety or effectiveness. The record does not support turning that into a dramatic ban story. It also does not justify stating, as a settled FDA finding, that “business reasons” were the sole cause.^[1]

The record can be reconstructed precisely: two applications, distribution ending around 1981, a 1992 withdrawal request, a 1993 effective withdrawal, and a 2017 FDA determination that the product was not removed for safety or effectiveness. What it cannot prove is the private commercial math that led the company not to keep selling it.

Here is the plain-English version: dydrogesterone is not missing from America because the FDA discovered a hidden danger. The historical products disappeared, the approval was withdrawn, and nobody has brought an active product back.

That is less dramatic than “banned.” It is also much more useful, because it tells you what to do next: stop hunting for the secret pharmacy and start translating the treatment goal.

Was dydrogesterone banned in the US?

No. FDA has never published a determination that dydrogesterone was banned for being unsafe or ineffective. In 2017, after reviewing agency records and published literature, FDA reached the opposite regulatory conclusion: Gynorest was not withdrawn for reasons of safety or effectiveness.^[1]

We are spending this much space on one word because banned makes women afraid of a medication they may have taken for years without any warning from the clinician who prescribed it.

If you are reading this from a hotel room after moving countries, worried that America rejected something dangerous: that is not what the record says.

Will dydrogesterone be approved in the US again?

There is no public sign of an imminent return. FDA cleared a legal path for a generic application in 2017, but that is permission to apply, not evidence that a company has applied. We found no approved generic as of September 1, 2026. Pending applications, if any, are not public.

The U.S. Pharmacopeia record is where the story changes.

USP proposed omitting the dydrogesterone monograph in 2019 and said the reference standard was unavailable at that time. The monograph is still current, and USP now lists a 200 mg Dydrogesterone Reference Standard for $319 and “In Stock.” That closes the former reference-standard gap, but it does not create an FDA-approved product.^[3][4][5]

Do not build your treatment plan around a return that nobody has announced.

What’s actually on your pack: Duphaston, Femoston, Femoston-conti, or Gynorest?

These names do not describe one interchangeable product. Duphaston supplies dydrogesterone alone. Femoston uses a sequential pack with estradiol every day and dydrogesterone during the second half. Femoston-conti supplies both hormones daily. Gynorest was a historical U.S. dydrogesterone-only product. Your exact pack determines the treatment job a U.S. clinician must rebuild.^[6]

The pack name is not enough: the strength, number of tablet colors, sequence, and original indication all matter. Femoston 1/10 and 2/10 contain the same 10 mg dydrogesterone dose during days 15–28; the difference is the estradiol strength.

The easy mistake is to read “Femoston 2/10” and assume the second number doubled. It did not. Both sequential strengths use 10 mg dydrogesterone during the second 14 days.

Before your appointment, write down or photograph:

1. The exact brand and strength
2. Whether the pack has one tablet color or two
3. The number of days you take each tablet
4. Why it was originally prescribed
5. Whether you have a uterus
6. Any bleeding pattern you were told to expect
7. The date of your last dose and how much supply remains

That is the handoff. A brand name alone is not.

Can a U.S. doctor prescribe dydrogesterone?

A U.S. clinician cannot write a normal retail prescription for an approved, marketed dydrogesterone product because no such U.S. product exists. The clinician can prescribe FDA-approved alternatives. Patient-specific compounding is a separate, conditional pathway — not a routine Duphaston prescription and not proof that a pharmacy can source or dispense it.^[7]

If your new clinician does not recognize Femoston immediately, that is not automatically a red flag. The useful move is to translate your regimen into its clinical parts.

That gives the clinician something actionable. The brand name by itself is a dead end.

Can a compounding pharmacy make dydrogesterone in the US?

Possibly under federal Section 503A conditions, because a current USP monograph exists. That does not mean a pharmacy is currently dispensing it, that every state permits it, or that a finished compounded capsule would be FDA-approved. We found no U.S. pharmacy we could verify publicly offering patient-specific compounded dydrogesterone as of September 1, 2026.^[4][7][8]

The legal framework is narrower than “a doctor can ask a compounder to make anything.”

The current monograph appears to open one federal ingredient-eligibility branch, but the prescription, source, certificate, facility, state-law, and pharmacy requirements still have to be met. The current USP reference standard removes one practical obstacle described in the 2019 notice. It does not turn a compounded product into Duphaston, a generic, or an FDA-reviewed substitute.

Do not let anyone sell you a compounded capsule by calling it “generic Duphaston,” “the same medication,” or “FDA-approved because the ingredient has a USP monograph.” Those phrases blur three separate things: ingredient eligibility, pharmacy compounding compliance, and finished-drug approval.

If a pharmacy offers compounded dydrogesterone, ask for written answers to these questions:

1. Which federal basis are you relying on for the bulk ingredient — the current USP monograph or another route?
2. Who manufactures the active ingredient, and is that establishment registered with FDA?
3. Can you provide the certificate of analysis for the lot used in my prescription?
4. Is this prepared only after a patient-specific prescription, and is it permitted under my state’s pharmacy rules?
5. Will you state in writing that the finished product is not FDA-approved and is not an FDA-approved generic of Duphaston?

A clear answer does not make compounded dydrogesterone equivalent to a manufactured foreign tablet. A vague answer is enough reason to stop.

Can I order Duphaston online or import it from another country?

Do not treat a foreign website or the phrase “90-day supply” as a dependable U.S. access plan. U.S. residents generally may not import unapproved prescription drugs for personal use. FDA may exercise enforcement discretion in narrow circumstances, but that is case-specific and not an entitlement. Foreign visitors have a separate documented-supply pathway that does not create an indefinite import right.^[9]

For a U.S. resident ordering a shipment, the personal-importation factors commonly include:

• A serious condition for which effective treatment may not be available domestically
• No commercialization or promotion to U.S. residents
• No unreasonable risk
• A quantity generally no greater than 90 days
• Written confirmation of personal use and a U.S. clinician’s oversight, or evidence that treatment began abroad

Menopause hormone therapy has multiple FDA-approved domestic options. That makes “no effective U.S. treatment” a poor fit for a routine preference for Duphaston or Femoston.

For a foreign national visiting the United States, FDA says a traveler may be allowed to bring or ship up to a 90-day supply with appropriate documentation. That can buy time. It is not a stable refill strategy after relocation, and Customs can still examine the medication.

The internet leaves out the most important sentence: enforcement discretion means FDA may choose not to object. It does not mean you have a legal right to the shipment.

We do not link to foreign sellers. FDA says it cannot ensure the safety or effectiveness of medicine bought from foreign sources.

So no, we did not find a workaround we would put our name on. What we found is a cleaner path: document the regimen, identify the treatment goal, and have a U.S. clinician choose an available option.

Is dydrogesterone safer than the progestogens available in the US?

The evidence does not support a universal “dydrogesterone is safer” verdict. Favorable French data are real, but later U.K., Korean, and Finnish observational studies do not all produce the same ordering. For venous clots, oral estradiol plus dydrogesterone had the lowest point estimate among oral combinations in one large study, while pooled transdermal preparations showed no statistically significant increase.^{[10][11][12][13][14]}

This is where the confidence intervals matter. Nobody gets to turn a quiet interval into a guarantee.

Five large observational datasets give a more honest picture than one favorite citation. Dydrogesterone often looks better than several older synthetic progestogens, but it does not consistently beat micronized progesterone across breast-cancer analyses. None of these studies proves that switching one individual woman from one product to another changes her personal outcome.

The honest reading is not “dydrogesterone is dangerous.” The record does not support that. It is also not “dydrogesterone is proven safest.” The studies are observational, product definitions differ, populations differ, treatment duration matters, and residual confounding remains possible.

What survives the evidence is this:

• Dydrogesterone has a favorable reputation for understandable reasons.
• Its breast-cancer evidence is mixed, not uniformly superior.
• Its oral venous-clot estimate was favorable relative to other oral combinations in the 2019 BMJ analysis.
• Transdermal estrogen may be the more actionable discussion when clot risk is the concern.

That is not as tidy as a ranking. It is much more useful in a real appointment.

If clot risk is why I wanted dydrogesterone, should I ask about a patch instead?

Yes — transdermal estrogen is a reasonable route to discuss, not a guaranteed upgrade. In the 2019 BMJ study, pooled transdermal preparations were not associated with a statistically significant increase in venous thromboembolism, while oral estradiol plus dydrogesterone had the lowest point estimate among oral combinations. The Menopause Society says transdermal routes and lower doses may reduce venous-clot and stroke risk.^[10][15]

The study numbers were:

• Oral estradiol + dydrogesterone: 1.18 (0.98–1.42)
• Oral conjugated estrogens + medroxyprogesterone acetate: 2.10 (1.92–2.31)
• All transdermal preparations pooled: 0.93 (0.87–1.01)

An interval that includes 1.0 means the study did not detect a statistically significant difference from nonuse. It does not prove zero risk, and it does not prove that one specific patch-plus-progestogen pair beats Femoston.

The route still matters. Oral estrogen passes through the liver first and has different effects on clotting-related proteins than estrogen delivered through the skin. That is why route belongs in the decision, especially for someone with venous-clot risk factors.

You were chasing a molecule. The bigger practical question may be the route.

The matching tool does not convert doses or prescribe medication. It helps you arrive at the right starting point.

What is the US equivalent of Femoston or Duphaston?

There is no exact U.S. equivalent, no validated milligram-for-milligram conversion, and no U.S. generic of Duphaston or Femoston. A clinician instead rebuilds the treatment goal: estrogen route and dose, endometrial protection if you have a uterus, sequential or continuous timing, bleeding preference, symptom control, contraindications, and the reason the original regimen was prescribed.^[15][16][18]

This is a conversation map, not a conversion chart. The products below use different estrogens, different progestogens, different doses, different delivery routes, and different schedules. None is therapeutically interchangeable with dydrogesterone, and nothing in this table tells you what dose to take.

The useful comparison is not “Which U.S. pill equals 10 mg dydrogesterone?” It is “What job is this pack doing, and which FDA-approved U.S. regimen can do that job for me?”

“Bioidentical” does not make two drugs equivalent. Micronized progesterone has the same chemical structure as endogenous progesterone. Dydrogesterone is a synthetic progestogen with a different structure. That difference does not automatically make either one safer, better tolerated, or correctly dosed for you.

FDA began approving updated prescribing information for menopausal hormone-therapy products in 2026. The first group announced on February 12 included Prometrium, Bijuva, Divigel, Estring, Cenestin, and Enjuvia. Not every product label changed on the same day, so use the current label for the exact product being prescribed.^[17]

What changes if I switch from dydrogesterone to oral micronized progesterone?

The most concrete label-based difference is bedtime dosing.U.S. progesterone-capsule labeling warns that dizziness and drowsiness can occur and directs bedtime use. That does not prove dydrogesterone never causes similar symptoms, and it does not tell us that sedation is every woman’s “biggest” or most common switching problem.^[16]

Here is what belongs in the conversation:

Drowsiness and dizziness

The progesterone label says some women may experience transient dizziness or drowsiness and should take the capsule at bedtime. Do not assume you will feel better, sleep better, or feel foggy. Those are individual responses, not promises.

Peanut oil and inactive ingredients

Prometrium’s current label lists peanut oil. Inactive ingredients can differ by manufacturer, so this is a product-specific question, not a safe universal statement about every possible progesterone product.

If you have a peanut allergy:

• Ask the prescriber to document it
• Ask the pharmacist to check the exact manufacturer and NDC being dispensed
• Read the current inactive-ingredient list before the first dose
• Do not accept “all progesterone is the same” as an answer

A custom peanut-free compounded capsule, if prescribed, would be a compounded drug and would not become FDA-approved because it contains progesterone.

Bleeding pattern

Changing the molecule, dose, or schedule can change bleeding. Nobody should promise that a Femoston withdrawal bleed will reproduce itself on the same calendar after a switch. Ask what bleeding is expected, how long the adjustment window is for the exact regimen, and what amount or pattern should trigger evaluation.

Endometrial protection

The FDA-label trial behind oral micronized progesterone reported endometrial hyperplasia in 6% of women using estrogen plus progesterone, compared with 64% using estrogen alone and 3% receiving placebo over up to 36 months.^[16]

That is strong evidence that the tested progesterone regimen reduced estrogen-associated hyperplasia. It is not a head-to-head trial against dydrogesterone, and the numbers should not be turned into a dose conversion.

Availability and cost

FDA-approved oral progesterone is widely prescribed in the United States, but insurance coverage, pharmacy stock, manufacturer, inactive ingredients, and cash price vary. Confirm the exact product and price at the pharmacy rather than treating a coupon-dependent number as universal.

What should I do if I’m moving to the US or running low?

Start before your final pack. You do not need to solve the substitution yourself. You do need to arrive with the exact product, schedule, indication, uterus status, bleeding pattern, allergy history, and remaining supply. Do not alter, stop, skip, or ration the regimen without instructions from the clinician managing your care.

Use this sequence:

1. Photograph the front, back, blister, and leaflet. Include the manufacturer and every strength printed on the pack.
2. Write the regimen in plain numbers. Include what you take on days 1–14 and days 15–28, or confirm that every tablet is the same.
3. Ask the current prescriber for an English summary. It should state the indication, start date, current schedule, uterus status if known, relevant risk history, and any prior intolerance.
4. Book a U.S. appointment before the final pack. Records, pharmacy questions, or a follow-up may take longer than one visit.
5. Lead with the regimen, not the brand. “Estradiol 1 mg daily plus dydrogesterone 10 mg on days 15–28” is more useful than “Femoston.”
6. Ask for the expected bleeding plan in writing. Sequential and continuous regimens answer different needs.
7. Ask which pharmacy will dispense the exact product. Confirm manufacturer and inactive ingredients if allergy is an issue.
8. Do not stretch the supply on your own. Symptom rebound is not the only concern; changing progestogen exposure while continuing estrogen can matter for the endometrium.

That is a much better use of your energy than calling pharmacies asking whether one of them has a hidden box of Duphaston.

Which online provider is most practical for replacing a foreign HRT regimen?

For this specific problem, Midi Health is our strongest starting-point fit when its insurance or self-pay model works for you: it offers a full video intake, prescribes FDA-approved options to a local pharmacy, and operates in all 50 states. Sesame is now a $59-per-month menopause membership, not a one-off visit. Winona’s public FDA-status pages conflict, so we do not recommend it for this switch without product-level verification.^[19][20][21]

This is an editorial conclusion under The HRT Index Verification Standard, not a clinical judgment. We evaluated the same five pillars in the same order: clinical legitimacy, care quality, medication fit, price transparency, access.

The table separates care fees from medication costs, identifies where prescriptions go, records the published cancellation terms we could verify, and refuses to award FDA-approved status where a provider’s own pages conflict. Prices and policies were checked September 1, 2026. Confirm them again during booking or checkout because provider terms can change without notice.

Sesame lists CBC, hemoglobin A1c, thyroid testing, a lipid panel, and a comprehensive metabolic panel as included when ordered. Its current page also publishes state-specific lab handling: direct-pay exceptions in New York, New Jersey, Rhode Island, and North Dakota; Labcorp routing in Arizona, Oklahoma, South Dakota, and Wisconsin; and Clinical Labs of Hawaii in Hawaii.^[20]

The damaging admission about Midi

Midi does notgive you a single predictable total that includes care, medication, and labs. If a flat subscription is your first priority, Sesame’s published $59 monthly care price is easier to understand.

But the separation creates the advantage that matters here: the clinician can send an FDA-approved prescription to a local pharmacy, so the medication is not trapped inside a proprietary product bundle. For a woman replacing a foreign regimen, that prescription portability is more valuable than pretending one box can be translated by checkout software.

That is a direct editorial link to Midi’s official site. Confirm insurance, clinician availability, labs, medication cost, and cancellation terms before paying.

Prefer the lower published membership price and ongoing messaging?

Affiliate link. We may earn a commission. Sesame’s $59/month membership covers care only; medication costs are additional. Confirm clinician availability and state eligibility before purchasing.

We are deliberately not placing a Winona treatment CTA here while its public FDA-status language conflicts. That is not punishment. It is the minimum proof standard this particular search deserves.

What if I take dydrogesterone for fertility, luteal support, or pregnancy?

The retail-availability answer is still no: there is no approved, marketed U.S. dydrogesterone product. The substitution answer is completely different from menopause care. U.S. progesterone products used in assisted reproduction have indication-specific labels and protocols, and a reproductive endocrinologist or obstetric clinician must decide whether, when, and how treatment changes.^[22]

We are a menopause resource. This is not menopause, and we are not going to pretend it is.

Endometrin is labeled for progesterone supplementation in women participating in assisted reproductive technology programs. Crinone 8% is labeled for progesterone supplementation or replacement as part of assisted reproductive technology treatment for infertile women with progesterone deficiency. Those labels do not make either product a self-directed replacement for a foreign dydrogesterone protocol.

If you are mid-cycle, post-transfer, pregnant, or close to running out, contact the clinic managing the protocol now. Do not switch, stop, or import based on a menopause article.

No provider funnel. No conversion table. Make the clinical call.

What if I take dydrogesterone for irregular cycles, PCOS, or abnormal bleeding?

Dydrogesterone’s historical U.S. approval covered amenorrhea and abnormal uterine bleeding, but that does not make a hormone refill the first step for unexplained bleeding today. Any postmenopausal bleeding requires prompt evaluation. Depending on the circumstances, the work-up may include transvaginal ultrasound, endometrial sampling, or both — not an automatic one-size-fits-all test.^[1][23]

The point is not that every case follows one identical test sequence. The point is that the cause must be evaluated rather than masked with a new progestogen.

Telehealth can help triage or arrange care, but a questionnaire cannot complete imaging or tissue sampling. If you have heavy bleeding, dizziness, fainting, severe pain, pregnancy possibility, or bleeding after menopause, seek prompt clinical evaluation rather than using this page to choose a product.

This page has given you the availability answer. For unexplained bleeding, that is where its usefulness ends.

What did The HRT Index actually verify?

We checked the original FDA withdrawal record, current FDA approval data, the 2019 USP omission notice, the current USP–NF monograph, the current USP reference-standard listing, four current Femoston product documents, the current 503A and importation rules, five observational datasets, current U.S. drug labels, and each provider’s own live pricing and policy pages.

Confirmed from primary or first-party sources

• FDA’s dates, applications, indications, withdrawal status, and 2017 safety/effectiveness determination
• The current absence of an approved-and-marketed U.S. dydrogesterone product in the FDA data checked September 1, 2026
• USP’s 2019 proposal to omit the monograph
• The continued current USP–NF monograph
• USP’s current 200 mg reference standard, listed at $319 and in stock
• The statutory 503A ingredient conditions and FDA’s warning that compounded drugs are not FDA-approved
• FDA’s personal-importation policy and the distinction between U.S. residents and foreign visitors
• Femoston and Femoston-conti ingredients and schedules
• Every risk estimate reproduced in the evidence table
• Current progesterone labeling on bedtime dosing, peanut oil, and the endometrial-hyperplasia trial
• Current provider prices, pharmacy models, lab inclusions, insurance statements, and published cancellation terms used in the comparison

Not publicly confirmable

• Whether a dydrogesterone application is pending with FDA; pending applications are not generally public
• Whether a U.S. pharmacy privately compounds dydrogesterone for individual patients but does not advertise it
• Whether a specific insurer will cover a specific replacement until the plan processes the exact product and claim
• Which medication a clinician will recommend after reviewing an individual history

Why there are no patient testimonials here

A testimonial cannot prove FDA status, legal availability, relative safety, or product equivalence. We found no reason to decorate a regulatory answer with an unverifiable first-person story. The proof on this page is the record: regulator, pharmacopeia, current product information, peer-reviewed studies, and provider terms.

This page follows The HRT Index Verification Standard. It does not use a numeric provider score, does not claim clinical review that did not occur, and does not present compounded medication as equivalent to an FDA-approved product.

Frequently asked questions

Is dydrogesterone FDA-approved in the United States?

It was historically approved under the Gynorest brand in 1978. That approval was withdrawn effective July 26, 1993. No approved, currently marketed U.S. product contains dydrogesterone as of September 1, 2026.

Is dydrogesterone banned in the US?

No. FDA determined in 2017 that Gynorest was not withdrawn for safety or effectiveness reasons. "Not currently available" and "banned" are not the same claim.

Why can't a U.S. pharmacy fill Duphaston?

Duphaston is not an approved, marketed U.S. product. A foreign prescription does not create a U.S. product, NDC, distribution channel, or pharmacy stock.

Is Femoston available in the US under another name?

No. No U.S. product combines estradiol and dydrogesterone. Bijuva combines estradiol with micronized progesterone, which is a different molecule and not a generic or equivalent of Femoston.

What is the closest U.S. alternative to Femoston?

There is no exact one. A sequential Femoston user may discuss separate estrogen plus cyclic progestogen; a continuous user may discuss FDA-approved combined products. The right answer depends on uterus status, bleeding plan, route, risk history, indication, and tolerance.

Can a U.S. doctor prescribe dydrogesterone?

Not as a normal FDA-approved retail product, because none is marketed. A clinician can prescribe FDA-approved alternatives. Patient-specific compounding may be legally possible if every applicable federal and state condition is met, but it is not the same as prescribing Duphaston.

Can a compounding pharmacy make dydrogesterone?

Potentially. A current USP monograph and reference standard exist. We did not verify a U.S. pharmacy publicly dispensing it, and any finished compounded product would not be FDA-approved or an FDA-approved generic.

Can I legally import a 90-day supply?

There is no blanket 90-day right for U.S. residents. FDA may exercise enforcement discretion in narrow cases. Foreign visitors have a separate documented-supply pathway, but it is not an indefinite refill plan after relocation.

Is dydrogesterone the same as progesterone?

No. Dydrogesterone is a synthetic progestogen. Micronized progesterone has the same chemical structure as endogenous progesterone. They are different drugs, not interchangeable generics.

Is dydrogesterone safer than micronized progesterone?

The observational evidence is mixed. Some studies are reassuring for dydrogesterone relative to older progestogens; later studies show modest associations with breast cancer. No dataset proves universal superiority for every woman.

Does transdermal estrogen have a lower clot risk than oral estrogen?

Large observational data and The Menopause Society's position statement support discussing transdermal routes when clot or stroke risk matters. That does not mean risk is zero or that every patch-plus-progestogen combination has been directly tested against Femoston.

Does insurance cover the U.S. alternatives?

It depends on the plan, formulary, product, prior-authorization rules, pharmacy, and diagnosis. Confirm the exact product with the insurer and pharmacy. Do not rely on a provider's general "insurance accepted" statement as a medication-coverage guarantee.

What should I do if I am about to run out?

Contact the current prescriber and book a U.S. clinician before the final pack is gone. Photograph the package, get an English treatment summary, write the exact schedule, and do not stop or ration without clinical instructions.

Will dydrogesterone return to the U.S. soon?

There is no public evidence that it will. The generic pathway exists, and the USP monograph and reference standard are current, but we found no approved-and-marketed product or announced U.S. launch.

Still not sure which HRT program is right for you?

You came here with one question, and the answer is settled: dydrogesterone is not available as an approved, marketed U.S. prescription product; it was not removed under an FDA safety ban; importation is not a dependable refill strategy; and a U.S. clinician can rebuild the treatment goal with available options.

Which provider model fits you still depends on your symptoms, uterus status, route preference, risk history, insurance, state, and whether online care is the right starting point.

The matching tool is free and does not convert doses or replace a clinical evaluation.

Related reading from The HRT Index

• HRT benefits and risks: what the evidence actually says
• What HRT costs in 2026
• Best online HRT providers for menopause
• Midi vs Alloy vs Winona vs Evernow
• Perimenopause symptoms checklist
• Micronized progesterone vs medroxyprogesterone
• Progestin vs progesterone for HRT

Sources

1. U.S. Food and Drug Administration, “Determination That GYNOREST (Dydrogesterone) Oral Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” Federal Register, September 6, 2017. federalregister.gov ↩
2. FDA, Drugs@FDA data files and Orange Book data files, current data checked September 1, 2026. fda.gov/drugs/drug-approvals-and-databases ↩
3. United States Pharmacopeia, “Notice of Intent to Revise: Dydrogesterone,” CN-19-041-00, May 31, 2019. uspnf.com ↩
4. United States Pharmacopeia, current USP–NF Dydrogesterone monograph. doi.usp.org ↩
5. United States Pharmacopeia, Dydrogesterone Reference Standard, catalog 1231003. store.usp.org ↩
6. Electronic Medicines Compendium, current Summaries of Product Characteristics for Femoston 1/10, Femoston 2/10, Femoston-conti 0.5/2.5, and Femoston-conti 1/5. ↩
7. FDA, “Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act.” fda.gov ↩
8. FDA, “Compounding and the FDA: Questions and Answers.” fda.gov ↩
9. FDA, “Personal Importation.” fda.gov/industry/import-basics ↩
10. Vinogradova Y, Coupland C, Hippisley-Cox J. “Use of hormone replacement therapy and risk of venous thromboembolism.” BMJ. 2019;364:k4810. bmj.com ↩
11. Fournier A, et al. “Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study.” PubMed 17333341 ↩
12. Vinogradova Y, Coupland C, Hippisley-Cox J. “Use of hormone replacement therapy and risk of breast cancer.” BMJ. 2020;371:m3873. bmj.com ↩
13. Yuk J-S, et al. “Relationship between menopausal hormone therapy and breast cancer: a nationwide population-based cohort study.” PubMed 38469634 ↩
14. Finnish nationwide case-control study of menopausal hormone therapy and breast cancer, 2025. PubMed 40107092 ↩
15. The Menopause Society, “The 2022 hormone therapy position statement.” PubMed 35797481 ↩
16. DailyMed, current progesterone-capsule prescribing information. dailymed.nlm.nih.gov ↩
17. FDA, “Menopausal Hormone Therapies With Updated Prescribing Information,” February 12, 2026. fda.gov ↩
18. DailyMed current label searches for Bijuva, estradiol/norethindrone acetate, Angeliq, CombiPatch, Climara Pro, and Prempro/Premphase. dailymed.nlm.nih.gov ↩
19. Midi Health, current pricing and insurance information. joinmidi.com/pricing-insurance ↩
20. Sesame, current menopause program and cancellation terms. sesamecare.com ↩
21. Winona, current product pricing, progesterone-capsule page, estrogen-patch page, FDA-status Help Center article, outside-pharmacy program, and refill-cancellation policy. bywinona.com ↩
22. DailyMed current labels for Endometrin and Crinone. dailymed.nlm.nih.gov ↩
23. American College of Obstetricians and Gynecologists, “The Role of Transvaginal Ultrasonography in Evaluating the Endometrium of Women With Postmenopausal Bleeding.” acog.org ↩

This page is editorial research, not medical advice, and has not been medically reviewed by a clinician. FDA-approved and compounded medications are labeled separately. A compounded preparation is not presented as an FDA-approved generic, an equivalent, or a proven safer option. Talk with a licensed clinician before starting, stopping, rationing, or changing hormone therapy.

Last verified September 2026 · Next scheduled review December 2026