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MYFEMBREE Drug Patent Profile

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

Myfembree is a drug marketed by Sumitomo Pharma and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and thirty-four patent family members in thirty-four countries.

The generic ingredient in MYFEMBREE is estradiol; norethindrone acetate; relugolix. There are seventy-five drug master file entries 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 January 27, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MYFEMBREE

International Patents:	134
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Drug Prices:	Drug price information 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:

INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035

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
Myovant Sciences GmbH	Phase 4
University of Chicago	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

US Patents and Regulatory Information for MYFEMBREE

MYFEMBREE is protected by seven US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035.

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	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes				Y
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes				Y

Expired US Patents for MYFEMBREE

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

International Patents for MYFEMBREE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2008094846	THIENOPYRIMIDINE COMPOUND AND APPLICATION THEREOF
Australia	2022241582	Methods of treating uterine fibroids and endometriosis
Japan	7043503
Taiwan	I663171
Poland	378002	Związki tienopirymidynowe i ich zastosowanie (THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF)
Mexico	PA05007990	COMPUESTOS DE TIENOPIRIMIDINA Y USO DE LOS MISMOS. (THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF.)
Croatia	P20190729

Supplementary Protection Certificates for MYFEMBREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1591446	21C1056	France		PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446	132021000000188	Italy		PRODUCT NAME: RELUGOLIX O UN SUO SALE(RYEQO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1565, 20210720
1591446	2022C/501	Belgium		PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1591446	C 2021 047	Romania		PRODUCT NAME: RELUGOLIX SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF NATIONAL AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716

MYFEMBREE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MYFEMBREE

Introduction to MYFEMBREE

MYFEMBREE, developed by Myovant Sciences in collaboration with Pfizer, is a significant advancement in the treatment of women's health issues, particularly for conditions such as uterine fibroids and endometriosis. This drug is a fixed-dose combination tablet containing relugolix, estradiol, and norethindrone acetate.

FDA Approvals and Indications

MYFEMBREE has received crucial FDA approvals that have shaped its market dynamics. Initially approved in May 2021 for the management of heavy menstrual bleeding associated with uterine fibroids, MYFEMBREE has since expanded its indications. In August 2022, the FDA approved MYFEMBREE for the management of moderate to severe pain associated with endometriosis, a significant milestone that broadens its therapeutic scope[1][4].

Commercial Launch and Early Adoption

The commercial launch of MYFEMBREE began in 2021, with initial sales reflecting the early stages of market penetration. By the end of September 2021, net product revenues from U.S. sales of MYFEMBREE were $0.6 million, primarily due to initial inventory stocking and modest demand-driven re-orders[1][2].

As of October 2021, approximately 600 patients had initiated treatment with MYFEMBREE, including those on commercial and free drug programs, excluding patients using product samples. This number increased to about 1,400 cumulative patients by November 2021, indicating growing adoption[1][5].

Payer Coverage and Market Access

Payer coverage is a critical factor in the financial trajectory of any pharmaceutical product. As of October 8, 2021, Myovant Sciences achieved 61% commercial coverage for MYFEMBREE, with ongoing negotiations to secure broader coverage. This coverage is essential for increasing patient access and driving revenue growth[1].

Financial Performance

The financial performance of MYFEMBREE has been closely tied to its commercial success and regulatory milestones. In the second fiscal quarter of 2021, MYFEMBREE generated $0.6 million in net product revenue. By the third fiscal quarter of 2021, this figure increased to $2.4 million, reflecting growing market acceptance and prescriber awareness[1][5].

Revenue Streams

MYFEMBREE's revenue is derived from several sources:

• Product Revenue: Direct sales of MYFEMBREE in the U.S. market.
• Pfizer Collaboration Revenue: This includes the partial recognition of the upfront payment from Pfizer and regulatory milestone payments triggered by FDA approvals. For example, the FDA approval for the management of heavy menstrual bleeding associated with uterine fibroids in May 2021 triggered a significant regulatory milestone payment[1][5].

Market Forecast and Potential

The market potential for MYFEMBREE is substantial, particularly in the endometriosis treatment space. According to GlobalData's Endometriosis Global Drug Forecast and Market Analysis to 2030, MYFEMBREE is anticipated to generate nearly $584 million in sales in the U.S. alone by 2030. This forecast is supported by the drug's strong clinical trial results, once-daily administration, and high potential for market penetration[4].

Clinical Efficacy and Safety

The clinical efficacy and safety of MYFEMBREE have been demonstrated through several Phase III trials, including the SPIRIT 1 and SPIRIT 2 trials. These trials showed significant pain reductions in women with dysmenorrhea and non-menstrual pelvic pain associated with endometriosis, outperforming placebo groups[4].

Competitive Landscape

MYFEMBREE operates in a competitive landscape that includes other GnRH antagonists like AbbVie’s Orilissa (elagolix) and Kissei Pharmaceuticals’ Yselty (linzagolix). However, MYFEMBREE’s once-daily administration and strong clinical trial outcomes position it favorably in the market[4].

Regulatory Milestones and Future Outlook

The FDA's acceptance of the supplemental New Drug Application (sNDA) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, with a target action date of May 6, 2022, was a significant regulatory milestone. The approval in August 2022 further solidifies MYFEMBREE's position in the market. Future regulatory milestones, including the submission of Phase 3 LIBERTY randomized withdrawal study results, will continue to shape its financial trajectory[1][4].

Key Takeaways

• FDA Approvals: MYFEMBREE has received FDA approvals for uterine fibroids and endometriosis, expanding its therapeutic indications.
• Commercial Performance: Initial sales were modest but have shown growth, with increasing patient and prescriber adoption.
• Payer Coverage: Achieved 61% commercial coverage as of October 2021, with ongoing efforts to secure broader coverage.
• Financial Forecast: Anticipated to generate nearly $584 million in U.S. sales by 2030.
• Clinical Efficacy: Demonstrated strong pain reduction outcomes in clinical trials.
• Competitive Landscape: Positioned favorably against other GnRH antagonists due to its once-daily administration and clinical trial results.

FAQs

Q: What are the primary indications for MYFEMBREE? A: MYFEMBREE is approved for the management of heavy menstrual bleeding associated with uterine fibroids and for the management of moderate to severe pain associated with endometriosis.

Q: How has MYFEMBREE performed financially since its launch? A: Initial sales were modest, with $0.6 million in net product revenue in the second fiscal quarter of 2021, increasing to $2.4 million by the third fiscal quarter of 2021.

Q: What is the market forecast for MYFEMBREE? A: MYFEMBREE is anticipated to generate nearly $584 million in U.S. sales by 2030, according to GlobalData's market analysis.

Q: How does MYFEMBREE compare to other GnRH antagonists in the market? A: MYFEMBREE is favorably positioned due to its once-daily administration and strong clinical trial outcomes, differentiating it from competitors like Orilissa and Yselty.

Q: What are the key regulatory milestones for MYFEMBREE? A: The FDA approval for endometriosis in August 2022 and the submission of Phase 3 LIBERTY randomized withdrawal study results are significant milestones.

Sources

1. Myovant Sciences Announces Financial Results for Second Quarter of Fiscal Year 2021 and Corporate Updates - Biospace
2. Myovant Sciences Announces Financial Results for Second Quarter of Fiscal Year 2021 and Corporate Updates - GlobeNewswire
3. Dysmenorrhea Treatment Market | Growth | Share | Size | Trends - Reanin
4. Myovant & Pfizer's MyFembree receives nod from the FDA for endometriosis - Clinical Trials Arena
5. Myovant Sciences Announces Financial Results for Third Quarter of Fiscal Year 2021 and Corporate Updates - Biospace