FEMLYV Drug Patent Profile

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

Femlyv is a drug marketed by Millicent Pr and is included in one NDA. There is one patent protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in FEMLYV is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Femlyv

There is one tentative approval for the generic drug (ethinyl estradiol; norethindrone acetate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for FEMLYV

International Patents:	6
US Patents:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for FEMLYV

FEMLYV is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millicent Pr	FEMLYV	ethinyl estradiol; norethindrone acetate	TABLET, ORALLY DISINTEGRATING;ORAL	218718-001	Jul 22, 2024		RX	Yes	Yes			Y
Millicent Pr	FEMLYV	ethinyl estradiol; norethindrone acetate	TABLET, ORALLY DISINTEGRATING;ORAL	218718-001	Jul 22, 2024		RX	Yes	Yes

International Patents for FEMLYV

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

Country	Patent Number	Title	Estimated Expiration
Australia	2021351921	Orodispersible formulations
Mexico	2023003432	FORMULACIONES ORODISPERSABLES. (ORODISPERSIBLE FORMULATIONS.)
World Intellectual Property Organization (WIPO)	2022069956
Canada	3194494	FORMULATIONS ORODISPERSIBLES (ORODISPERSIBLE FORMULATIONS)

Supplementary Protection Certificates for FEMLYV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

Investment Scenario and Fundamentals Analysis for FEMLYV

Last updated: February 19, 2026

What is FEMLYV?

FEMLYV (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist developed by Myovant Sciences. It is approved in the United States for the treatment of heavy menstrual bleeding associated with uterine fibroids in adult women and for endometriosis, with a broader potential market. FEMLYV's key advantage is oral administration, contrasting with traditional injectable therapies.

Market and Regulatory Status

Aspect	Details
FDA Approval	Approved July 2021 for uterine fibroids and endometriosis
Approved Indications	Heavy menstrual bleeding due to uterine fibroids, endometriosis
Market Size (US)	Uterine fibroids: ~$1.5B annual market; Endometriosis: ~$900M annual market[1],[2]
Market Penetration	Launches are ongoing; initial adoption in specialty clinics

Competitive Landscape

• Oral GnRH antagonists: Elagolix (AbbVie, approved 2018), relugolix is positioned as a competitor.
• Injectable GnRH analogs: Leuprorelin, goserelin.
• Emerging opportunities: Combination therapies and expanding approved indications.

Investment Fundamentals

Revenue Drivers

• Market Penetration: The speed of uptake in gynecology practices.
• Pricing Strategy: Orally administered drugs command a premium, but price sensitivity exists due to competition.
• Formulation and Delivery: Patient compliance is improved with oral delivery, leading to higher market share potential.

Cost Structure and Margins

• R&D expenses largely amortized; ongoing costs involve marketing, distribution, and regulatory compliance.
• Gross margins are estimated at approximately 80% for pharmaceutical products post-commercialization, factoring in manufacturing costs.

Pipeline and Expansion Opportunities

Potential Expansion Area	Timeline	Notes
Additional indications	2023-2025	Endometriosis-related pain, prostate cancer in men[3]
Global markets	2024–2026	Europe, Asia-Pacific markets; regulatory timelines vary
Combination therapies	2025+	With hormone therapies, for osteoporosis or other hormone-dependent conditions

Regulatory Considerations

• US: Approved via NDA; Post-marketing commitments include ongoing safety monitoring.
• Europe: Filing submitted or planned; approval timing uncertain.
• Phase III trials: Additional indications may require further regulatory reviews.

Financial Outlook and Valuation

• Revenue projections: Estimated to reach $500M by 2025, driven by the uterine fibroids and endometriosis markets.
• Profitability: Economies of scale expected to improve margins; breakeven projected in 2023–2024.
• Market cap implications: Based on initial adoption rates, potential for upside if global approval accelerates and indications expand.

Risks and Challenges

• Market penetration rate: Slow adoption could limit revenue.
• Competitive pressure: Elagolix and future oral GnRH antagonists may erode market share.
• Regulatory delays: Pending approval timelines outside the US could impact growth.
• Safety Profile: Long-term safety data is still accruing; adverse effects could limit use.

Key Takeaways

• FEMLYV holds a significant market opportunity given its indications and the convenience of oral administration.
• Rapid market adoption hinges on physician acceptance and payer coverage.
• Competitive landscape remains intense, with elagolix as a primary competitor.
• Expansion into additional indications and international markets could drive growth.
• Investors should monitor regulatory developments, sales data, and competitive dynamics closely.

FAQs

1. What are the primary indications for FEMLYV?
Uterine fibroids-associated heavy menstrual bleeding and endometriosis.

2. How does FEMLYV compare to competitors like elagolix?
FEMLYV offers an oral alternative to injectable GnRH antagonists, with similar efficacy, aiming for improved patient compliance.

3. When are broader market approvals expected?
Europe’s approval timeline varies; additional indications are in clinical or regulatory review, with potential expansion from 2023 onwards.

4. What are the main risks to investment?
Delayed market penetration, competition, safety concerns, and regulatory hurdles outside the US.

5. What are the future growth opportunities?
Global expansion, partnership deals, and indication expansion, including potential off-label uses in other hormone-dependent conditions.

References

[1] IBISWorld. (2022). Uterine Fibroids Market Report.
[2] Grand View Research. (2022). Endometriosis Market Size.
[3] Myovant Sciences. (2022). FEMLYV (relugolix) Clinical Development Pipeline.