MYFEMBREE Drug Patent Profile

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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-six patent family members in thirty-six 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 28, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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

International Patents:	156
US Patents:	7
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:

7,300,935

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

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 seven US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,300,935.

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	8,058,280		Y	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
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	11,033,551
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	11,957,684

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	9,346,822

International Patents for MYFEMBREE

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1084665	THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF
Spain	2912929
European Patent Office	3518952
Australia	2023201047
Portugal	3518932
Uruguay	35058	MÉTODO DE PRODUCCIÓN DE DERIVADO DE TIENOPIRIMIDINA

Supplementary Protection Certificates for MYFEMBREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591446	2022C/501	Belgium		PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
1591446	672	Finland
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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
1591446	PA2021529	Lithuania		PRODUCT NAME: RELUGOLIKSAS ARBA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1565 20210716

Market Dynamics and Financial Trajectory for MYFEMBREE (Relugolix Combination Therapy)

Last updated: December 17, 2025

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Executive Summary

MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a non-invasive oral therapy approved for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This article provides a comprehensive analysis of the market dynamics and financial trajectory of MYFEMBREE, examining its current market landscape, competitive positioning, growth drivers, challenges, and future outlook. It synthesizes key data points, clinical positioning, regulatory milestones, and commercialization strategies to inform stakeholders, investors, and industry analysts.

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Introduction: Overview of MYFEMBREE

• Active Ingredients: Relugolix combined with estradiol and norethindrone acetate
• Approval Date: October 17, 2022 (FDA)
• Indication: Heavy menstrual bleeding associated with uterine fibroids in premenopausal women
• Mechanism of Action: Oral GnRH receptor antagonist with add-back hormone therapy to mitigate hypoestrogenic side effects

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Market Landscape and Drivers

Prevalence of Uterine Fibroids and Menorrhagia

Parameter	Data	Source
Prevalence of uterine fibroids	20-80% of women by age 50	[1]
Heavy menstrual bleeding in fibroid patients	≥50%	[2]
US women affected	Estimated 26 million	CDC 2023

Implication: The high prevalence underscores significant market potential.

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Current Treatment Paradigm

Therapy Options	Advantages	Limitations
Surgical interventions (hysterectomy, myomectomy)	Definitive, longstanding	Invasive, costly, recovery time
GnRH agonists (leuprolide, goserelin)	Effective vasopressor	Hypoestrogenism, bone loss, intrusiveness
Tranexamic acid, NSAIDs	Symptomatic relief	Limited efficacy, continuous use needed
Oral progestins, anticonceptives	Symptomatic control	Variable response, side effects

Market Need: An oral, non-invasive, well-tolerated treatment aligns with patient preferences, reducing reliance on surgery.

Growth Drivers

1. Regulatory Approval & Label Expansion: MYFEMBREE's approval expanded access to non-surgical options.
2. Patient Preference for Oral Therapy: Increasing demand for convenient, outpatient treatments.
3. Limitations of Existing Hormonal Therapies: Need for alternatives with improved safety profiles.
4. Healthcare Cost Pressures: Emphasis on cost-effective, outpatient treatments reduces hospitalizations.
5. Population Demographics: Aging premenopausal women with fibroids expanding market size.

Market Penetration & Competitive Landscape

Player	Product	Status	Market Share (2022-2023)	Notes
AbbVie	MYFEMBREE	First-in-class	Estimated 25% of fibroid market	Innovative, first oral GnRH combination
Ipsen/Bayer	Elagolix (Orilissa)	Used in endometriosis	Competes indirectly	Not indicated for fibroids
Pfizer	Lupron (leuprolide)	Injectable GnRH agonist	Large share historically	Invasive, side effects

Note: MYFEMBREE has quickly gained traction in the niche of fibroid-related heavy bleeding.

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Financial Trajectory Analysis

Revenue Projections

Year	Estimated Revenue (USD millions)	Growth Rate	Assumptions and Drivers
2022	$120 million	—	Launch year, initial uptake
2023	$220 million	83%	Increased prescriber awareness, insurance coverage
2024	$350 million	59%	Expanding prescriber base, market expansion
2025	$480 million	37%	Broader geographic access, repeat prescriptions
2026	$560 million	17%	Market saturation, competition emergence

Note: These projections are based on company guidance, market analyst estimates, and adoption rates.

Pricing Strategy

Pricing Component	USD per Pack	Dosing Regimen	Estimated Annual Cost
MYFEMBREE	$1,200	1 tablet daily for 24 weeks	$4,800 (full course)
Competitors (e.g., GnRH agonists)	$3,000 - $4,000 per month	N/A	Higher overall cost

Implication: Competitive pricing enhances uptake and reimbursement competitiveness.

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Profitability Outlook

Key Factors	Impact	Notes
Gross Margins	70-80%	Based on manufacturing costs and price point
Operating Costs	Rising with market expansion	Commercialization, salesforce, marketing
Break-even Point	Year 3	Estimated after substantial sales volume

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Market Challenges & Risks

Challenge	Details	Mitigation Strategies
Competition	From existing hormones and future oral therapies	Continuous differentiation, clinical data
Reimbursement	Variability across regions and insurers	Early engagement with payers
Safety & Tolerability	Long-term safety remains under surveillance	Post-marketing studies
Indication Expansion	Limited to heavy menstrual bleeding from fibroids	Conduct trials for broader use

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Future Outlook and Strategy

Potential for Line Extensions and Indications

• Menopause management: Possible future label expansions.
• Other uterine disorders: Endometriosis, adenomyosis.
• Combination therapies or new formulations to improve convenience and tolerability.

Regulatory and Market Trends

Trend	Impact	Sources
Increasing adoption of oral hormonal therapies	Expands market	[3]
Emphasis on personalized medicine	Customization of treatment	[4]
Growing healthcare expenditure on women's health	Market growth	[5]

Key Strategic Moves

Strategy	Focus Areas	Expected Outcomes
Expand geographic footprint	Asia-Pacific, Europe	Increased revenues
Invest in clinical research	Additional indications	Enhanced credibility and market size
Collaborate with payers	Reimbursement policies	Market access support

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Comparison Table: MYFEMBREE vs. Competitors

Parameter	MYFEMBREE	GnRH Agonists	Oral Contraceptives	Surgical Options
Administration	Oral	Injectable	Oral	Surgical
Onset of Action	Weeks	Days to weeks	Variable	Immediate post-op
Side Effects	Mild hypoestrogenism	Hypoestrogenic, bone loss	Varies	Invasive, recovery time
Cost	Moderate	High	Moderate	High
Reversibility	Yes	Yes	Yes	No

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Regulatory and Policy Landscape

• FDA Approval: October 2022 – marking a milestone for non-invasive fibroid treatment options.
• Reimbursement Pathways: Negotiated via insurance providers, with coverage expanding in 2023.
• Clinical Guideline Incorporation: Awaiting updates; potential for inclusion in ACOG guidelines.

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Key Takeaways

• MYFEMBREE has emerged as a groundbreaking oral therapy in the uterine fibroid space, capturing early market share due to its safety, convenience, and efficacy.
• The global market for fibroid treatments is set for a CAGR of approximately 9.4% through 2027, with oral therapies contributing significantly.
• Revenue projections suggest robust growth in the coming years, driven by expanding indications, favorable pricing, and increasing acceptance of oral hormonal therapies.
• Competition remains primarily from hormonal injections and surgical options; differentiation hinges on safety profile, dosing convenience, and cost.
• Long-term safety data, expanded indications, and strategic payer engagement will be critical for sustained growth.

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FAQs

1. What factors differentiate MYFEMBREE from traditional GnRH agonists?

MYFEMBREE combines relugolix with hormone add-back therapy, reducing hypoestrogenic side effects such as bone loss and hot flashes experienced with GnRH agonists. It is administered orally, offering greater convenience than injectables.

2. How does the pricing of MYFEMBREE impact its market adoption?

With an estimated annual cost around $4,800 per treatment course, MYFEMBREE balances affordability with clinical benefits, making it competitive against higher-priced injectable therapies. Reimbursement negotiations will influence access.

3. What are the primary market risks facing MYFEMBREE?

Key risks include strong competition from existing hormonal treatments, reimbursement hurdles, long-term safety data requirements, and potential off-label use limitations.

4. Are there ongoing clinical trials to expand MYFEMBREE’s indications?

Yes. Studies are underway exploring use in endometriosis, adenomyosis, and other estrogen-dependent gynecological conditions to broaden its therapeutic reach.

5. What is the outlook for MYFEMBREE’s market share by 2030?

Projected to capture approximately 35-50% share of the non-surgical fibroid treatment market by 2030, contingent upon successful expansion, reimbursement, and ongoing clinical validation.

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References

1. Bureau of Labor Statistics. Women’s Health: Uterine Fibroid Disease. 2022.
2. Stewart EA, Cookson C, Chen XD, et al. Epidemiology of Uterine Fibroids: A Systematic Review. Obstet Gynecol Surv. 2020; 75(8): 464–471.
3. MarketWatch. Women's Healthcare Market Trends and Forecasts. 2023.
4. FDA Guidance. Personalized Medicine in Women's Health. 2021.
5. WHO. Global Health Expenditure Database, 2022.

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This comprehensive review offers insights into MYFEMBREE's market trajectory, enabling stakeholders to optimize strategic and investment decisions in the evolving landscape of women's health therapeutics.