MYFEMBREE Drug Patent Profile

« Back to Dashboard

When do Myfembree patents expire, and what generic alternatives are available?

Myfembree is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in MYFEMBREE is estradiol; norethindrone acetate; relugolix. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norethindrone acetate; relugolix profile page.

DrugPatentWatch^® Generic Entry Outlook for Myfembree

Myfembree was eligible for patent challenges on December 18, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 5, 2042. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for MYFEMBREE

US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Drug Prices:	Drug price information for MYFEMBREE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYFEMBREE
What excipients (inactive ingredients) are in MYFEMBREE?	MYFEMBREE excipients list
DailyMed Link:	MYFEMBREE at DailyMed

See drug prices for MYFEMBREE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYFEMBREE

Constraining patent/regulatory exclusivity:

12,551,447

NDA:

214846

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MYFEMBREE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Chicago	Phase 4
Myovant Sciences GmbH	Phase 4
Myovant Sciences GmbH	Phase 3

See all MYFEMBREE clinical trials

Pharmacology for MYFEMBREE

Drug Class	Estrogen Gonadotropin Releasing Hormone Receptor Antagonist Progestin
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Estrogen Receptor Agonists Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors
Physiological Effect	Decreased GnRH Secretion

Paragraph IV (Patent) Challenges for MYFEMBREE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYFEMBREE	Tablets	estradiol; norethindrone acetate; relugolix	1 mg/0.5 mg/40 mg	214846	1	2024-12-18

US Patents and Regulatory Information for MYFEMBREE

MYFEMBREE is protected by eight US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 12,551,447.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	11,793,812
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	12,551,447		Y
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	12,325,714		Y	Y
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	8,058,280		Y	Y

Expired US Patents for MYFEMBREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021	8,058,280
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021	9,346,822

International Patents for MYFEMBREE

When does loss-of-exclusivity occur for MYFEMBREE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Ecuador

European Patent Office

Israel

Japan

Mexico

Paraguay

Peru

South Korea

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MYFEMBREE around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	109759
Argentina	109762
Argentina	110636
Australia	2017334035

Supplementary Protection Certificates for MYFEMBREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

MYFEMBREE Market Dynamics, Financial Trajectory, Patent Risk, and Competitive Outlook

Last updated: September 29, 2026

Myfembree is a once-daily oral combination of relugolix, estradiol, and norethindrone acetate marketed by AbbVie in the United States under a collaboration with Sumitomo Pharma. The FDA approved Myfembree in 2021 for heavy menstrual bleeding associated with uterine fibroids and in 2022 for moderate-to-severe pain associated with endometriosis.[1][2]

The product has a differentiated delivery profile and two sizable women’s-health indications, but its commercial ceiling is limited by a boxed warning, a 24-month treatment restriction, competition from established hormonal and surgical therapies, and the absence of a curative benefit. Its financial trajectory is positive but remains modest relative to AbbVie’s flagship immunology and oncology products.

What is Myfembree and how does it work?

Myfembree combines three active ingredients:

Component	Pharmacologic role
Relugolix	Gonadotropin-releasing hormone receptor antagonist that suppresses ovarian estrogen and progesterone production
Estradiol	Estrogen add-back therapy intended to reduce hypoestrogenic effects
Norethindrone acetate	Progestin add-back therapy that supports endometrial protection

The product is administered once daily as one tablet. The combination is designed to suppress ovarian hormone production while reducing vasomotor symptoms and bone mineral loss associated with relugolix monotherapy.[1][2]

Myfembree competes with injectable GnRH agonists, oral GnRH antagonists, hormonal contraceptives, progestins, tranexamic acid, intrauterine devices, and surgical procedures.

What FDA indications does Myfembree have?

Myfembree has two FDA-approved indications:

FDA milestone	Date	Indication
Initial approval	May 2021	Heavy menstrual bleeding associated with uterine fibroids
Expanded approval	August 2022	Moderate-to-severe pain associated with endometriosis

The endometriosis approval expanded the addressable market beyond fibroid-related bleeding. Clinical development relied on the SPIRIT 1 and SPIRIT 2 trials for endometriosis and the LIBERTY trials for uterine fibroids.[1][2]

Treatment is limited to 24 months because of the risk of continued bone mineral density loss. The label also contains a boxed warning concerning thromboembolic and vascular events associated with estrogen and progestin exposure.[1]

How large is the Myfembree market?

Myfembree addresses two large but fragmented markets.

Uterine fibroids

Uterine fibroids affect a substantial proportion of reproductive-age women and are a major cause of heavy menstrual bleeding, anemia, pain, and hysterectomy. Drug treatment is often used to control symptoms or delay surgery rather than provide permanent disease modification.

The principal commercial opportunity is among women who:

• Have heavy menstrual bleeding but want to avoid surgery;
• Need a bridge to surgery;
• Are seeking medical treatment before menopause;
• Cannot tolerate or do not respond adequately to contraceptives or progestins;
• Prefer an oral treatment to injectable GnRH therapy.

Endometriosis

Endometriosis is a chronic pain disorder with recurrent treatment demand. Many patients cycle through oral contraceptives, progestins, nonsteroidal anti-inflammatory drugs, surgery, and hormonal suppression.

Myfembree’s once-daily dosing and add-back regimen support positioning for patients who require longer-term symptom management. The 24-month label restriction, however, limits lifetime exposure and reduces the product’s value as a continuous chronic therapy.

How is Myfembree positioned against competing drugs?

Product	Active ingredient or class	Main commercial strength	Principal limitation
Myfembree	Relugolix plus estradiol/norethindrone	Once-daily oral therapy with built-in add-back regimen; two indications	24-month treatment limit and boxed warning
Orilissa	Elagolix	Established oral GnRH antagonist for endometriosis	Dose-related hypoestrogenic effects; treatment-duration limits
Lupron Depot	Leuprolide	Long clinical history and broad physician familiarity	Injection, flare risk, hypoestrogenic effects
Oriahnn	Elagolix plus estradiol/norethindrone	Oral combination for fibroid-related bleeding	Safety restrictions and limited commercial momentum
Aygestin and generic progestins	Norethindrone and related agents	Low cost and broad availability	Less targeted hormonal suppression
Hormonal IUDs	Levonorgestrel	Low-cost, long-duration local therapy	Placement requirement and variable effectiveness
Surgery	Hysterectomy, myomectomy, ablation	Definitive or procedural symptom relief	Invasiveness, fertility impact, and cost

AbbVie’s control of both Myfembree and Orilissa creates a women’s-health portfolio covering two oral GnRH antagonist products. The products overlap in endometriosis but differ in formulation and labeling. Myfembree’s add-back formulation supports a longer treatment concept than relugolix or elagolix monotherapy, although the label still imposes a 24-month limit.

What is the financial trajectory for Myfembree?

Myfembree’s revenue trajectory has been expansionary since launch, driven by the second FDA indication, increasing physician awareness, and broader payer coverage. AbbVie does not consistently provide a detailed standalone Myfembree revenue series in the same manner as Skyrizi, Rinvoq, or Botox. Public financial disclosures therefore support directional analysis more reliably than a precise annual sales reconstruction.[3][4]

The commercial trajectory has four stages:

Period	Commercial development
2021	Launch in uterine fibroids
2022	Endometriosis approval expands prescribing opportunity
2023	Integration into AbbVie’s commercial infrastructure following Sumitomo’s acquisition of Myovant
2024 onward	Greater focus on penetration, payer access, treatment persistence, and lifecycle management

Sumitomo’s acquisition of Myovant Sciences in 2023 consolidated its ownership position in the relugolix franchise. AbbVie retained U.S. commercialization rights for Myfembree under its collaboration arrangement, while Sumitomo remained economically exposed through royalties and related collaboration economics.[4][5]

The asset is commercially meaningful for Sumitomo’s women’s-health strategy but is not a core revenue driver for AbbVie. For AbbVie, Myfembree contributes to the diversification of its women’s-health portfolio. For Sumitomo, the product has greater strategic importance because the company has fewer large global products than AbbVie.

What factors will drive future Myfembree sales?

Expansion of diagnosed and treated patients

Many women with fibroids or endometriosis remain untreated, undertreated, or managed with repeated procedures. Greater diagnosis and referral to gynecologists could expand the treated population.

Oral convenience

Myfembree avoids injections and does not require patients to assemble a separate add-back regimen. This supports use in patients who are unwilling to receive depot therapy or who prefer oral treatment.

Payer access

Commercial growth depends on prior authorization requirements, step therapy, specialty-pharmacy distribution, and coverage relative to generic progestins and contraceptive products. A high list price creates friction against low-cost alternatives.

Endometriosis persistence

Endometriosis is a recurrent disease. Patients may discontinue treatment because of adverse events, incomplete pain control, pregnancy planning, or the 24-month treatment ceiling. Persistence will determine whether the endometriosis indication produces durable revenue or mainly accelerates patient turnover.

Gynecologist adoption

Myfembree’s growth is tied to gynecologist prescribing behavior. Physicians who routinely use hormonal contraceptives, progestins, or surgery may require evidence of superior symptom control, tolerability, and economic value before changing treatment patterns.

What patents protect Myfembree?

Myfembree is protected by a combination of patents covering the relugolix combination, pharmaceutical composition, dosing regimen, and therapeutic use. The relevant estate is more complex than a single active-ingredient patent because relugolix is also used in Orgovyx, an oncology product.

The principal protection categories are:

• Relugolix, estradiol, and norethindrone combination compositions;
• Oral dosage forms;
• Hormone-suppression regimens;
• Add-back therapy;
• Treatment of uterine fibroid symptoms;
• Treatment of endometriosis-associated pain;
• Manufacturing and formulation processes.

The strongest commercial protection is likely to come from combination and method-of-use claims rather than the underlying relugolix molecule alone. A generic applicant could challenge individual patents without necessarily invalidating the entire estate.

What is the Orange Book status of Myfembree?

Myfembree is an FDA-approved small-molecule drug and is eligible for generic competition through the abbreviated new drug application pathway. It is not a biologic and therefore is not exposed to biosimilar substitution under the Public Health Service Act.

Orange Book-listed patents and regulatory exclusivities determine the timing of potential ANDA approvals. The relevant challenges would likely involve Paragraph IV certifications alleging that listed patents are invalid, unenforceable, or not infringed.[6]

The commercial impact of an ANDA filing would depend on:

1. The number of patents listed for the reference product;
2. The earliest expiration date of enforceable claims;
3. Whether the generic applicant seeks a full label or a skinny label;
4. Whether AbbVie or Sumitomo initiates Hatch-Waxman litigation;
5. Whether a 30-month stay delays FDA approval;
6. Whether the parties reach a settlement allowing a controlled launch.

When could Myfembree lose exclusivity?

The key loss-of-exclusivity risk is not limited to one patent expiration date. Myfembree’s effective exclusivity period depends on the interaction among:

• Orange Book patent expiration dates;
• Patent-term adjustment and patent-term extension;
• FDA regulatory exclusivity;
• Paragraph IV litigation;
• Potential settlements;
• Pediatric exclusivity;
• Generic-label design.

The product does not have biosimilar risk because it is a small molecule. Its primary threat is generic relugolix combination competition.

A generic entrant could initially target fibroid or endometriosis use through a full-label or carve-out strategy. Because the product has two indications, method-of-use patents may create asymmetric risk. A skinny-label generic could avoid one patented indication while entering for another, depending on the final Orange Book listing and approved labeling.

What generic entry risks exist for Myfembree?

Generic entry would place pressure on:

• Net price;
• Payer rebate levels;
• Patient copay support;
• Specialty-pharmacy economics;
• Physician willingness to prescribe the branded product;
• Royalty income to Sumitomo;
• AbbVie’s women’s-health portfolio profitability.

The most likely launch pattern would be a gradual erosion rather than an immediate collapse if the brand retains formulary preference, patient-support programs, or clinically meaningful differentiation. Combination products can also face manufacturing and regulatory barriers that delay broad generic availability.

The principal technical barriers involve maintaining the fixed-dose combination, demonstrating bioequivalence for all active ingredients, reproducing dissolution and stability profiles, and complying with any device or packaging requirements. These barriers can slow entry but do not provide the protection of a biologic manufacturing process.

What patent litigation and settlement risks affect Myfembree?

Through the publicly available regulatory and corporate information used for this analysis, no major final judgment invalidating the core Myfembree patent estate has established an immediate generic launch date. The relevant litigation risk remains prospective and depends on future ANDA filings.

A Paragraph IV dispute could produce:

• A 30-month statutory stay;
• A negotiated launch date;
• A license with royalties;
• An authorized-generic arrangement;
• Patent invalidation or non-infringement;
• Delayed approval until the relevant patent expires.

A settlement would probably preserve some period of branded exclusivity while setting a defined generic entry date. Its value would depend on the size of the addressable patient population and the remaining duration of the 24-month treatment restriction.

How strong is the Myfembree patent estate?

The estate has moderate commercial strength.

Its strengths are:

• Two FDA-approved indications;
• A fixed-dose combination that is harder to design around than a single active ingredient;
• Method-of-use claims tied to specific gynecologic conditions;
• Integration with AbbVie’s commercial and legal infrastructure;
• Potential manufacturing and formulation complexity.

Its weaknesses are:

• Small-molecule ANDA exposure;
• Potential overlap with earlier relugolix technology;
• Limited treatment duration;
• Multiple possible invalidity and non-infringement paths;
• A market with inexpensive hormonal substitutes;
• The possibility of skinny-label generic entry.

The product’s patent position is stronger than a single-use, single-formulation product but weaker than a biologic protected by regulatory exclusivity and complex manufacturing barriers.

What is the competitive outlook for Myfembree?

Myfembree should retain a defensible position in women’s health while expanding within a constrained market. Its strongest commercial proposition is the combination of oral convenience, integrated add-back therapy, and two indications. Its largest risks are treatment duration, safety restrictions, generic hormonal alternatives, and limited visibility of product-level revenue.

AbbVie can support the product with payer contracting, specialist promotion, patient services, and cross-portfolio expertise. Sumitomo has a stronger incentive to maximize penetration because the product has greater relative importance to its revenue base.

The most probable financial path is continued sales growth during the remaining protected period, followed by slower growth as the addressable pool matures and eventual price erosion after generic entry. Myfembree is unlikely to become an AbbVie-scale blockbuster, but it can remain a meaningful specialty product and an important component of Sumitomo’s women’s-health franchise.

Key Takeaways

• Myfembree is approved for uterine fibroid-related heavy menstrual bleeding and endometriosis-associated pain.
• The product’s core differentiation is a once-daily oral relugolix combination with built-in estradiol and norethindrone add-back therapy.
• Revenue growth has been supported by the 2022 endometriosis approval and AbbVie’s commercial infrastructure.
• AbbVie does not provide a consistently detailed standalone sales series, limiting precise public revenue modeling.
• The product faces generic ANDA risk, not biosimilar risk.
• Patent protection is based on combination, formulation, dosing, and method-of-use claims.
• The 24-month treatment limit and boxed warning constrain persistence and long-term revenue per patient.
• Sumitomo has greater financial exposure to Myfembree than AbbVie, while AbbVie has greater commercialization strength.
• Generic entry would likely pressure price and payer positioning before causing full volume displacement.
• Myfembree’s patent estate is commercially meaningful but not as difficult to challenge as a biologic or complex injectable product.

FAQs

Is Myfembree a biologic or a small-molecule drug?

Myfembree is a small-molecule oral drug. Generic applicants would use the ANDA pathway rather than the biosimilar pathway.

Does Myfembree treat uterine fibroids permanently?

No. Myfembree controls heavy menstrual bleeding associated with uterine fibroids. It does not remove fibroids or provide a permanent cure.

Why is Myfembree limited to 24 months?

The FDA limits treatment duration because of bone mineral density loss and the potential for irreversible skeletal effects. The boxed warning also addresses cardiovascular and thromboembolic risks associated with estrogen and progestin exposure.

Who owns Myfembree?

AbbVie commercializes Myfembree in the United States under a collaboration with Sumitomo Pharma. Sumitomo acquired Myovant Sciences, which developed relugolix-based products with AbbVie.

Is Myfembree more commercially important to AbbVie or Sumitomo?

Myfembree is strategically more important to Sumitomo because of the company’s smaller portfolio and its exposure to relugolix-related economics. For AbbVie, the product is a specialty women’s-health asset within a much larger pharmaceutical portfolio.

References

1. U.S. Food and Drug Administration. (2021). Myfembree prescribing information.
2. U.S. Food and Drug Administration. (2022). FDA approves Myfembree for moderate to severe pain associated with endometriosis.
3. AbbVie Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
4. AbbVie Inc. (2023). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
5. Sumitomo Pharma Co., Ltd. (2023). Acquisition of Myovant Sciences Ltd. and related corporate disclosures.
6. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.

DrugChatter Q&A for MYFEMBREE

Does medicare cover myfembree?
How much is myfembree with insurance?
Myfembree manufacturer coupon?
Myfembree?
Is myfembree hormone replacement therapy?