FEMRING Drug Patent Profile

Which patents cover Femring, and when can generic versions of Femring launch?

Femring is a drug marketed by Millicent Mfg Pr and is included in one NDA.

The generic ingredient in FEMRING is estradiol acetate. 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 acetate profile page.

Summary for FEMRING

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	1
Patent Applications:	540
Drug Prices:	Drug price information for FEMRING
Drug Sales Revenues:	Drug sales revenues for FEMRING
What excipients (inactive ingredients) are in FEMRING?	FEMRING excipients list
DailyMed Link:	FEMRING at DailyMed

See drug prices for FEMRING

See drug sales revenues for FEMRING

Recent Clinical Trials for FEMRING

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

Sponsor	Phase
Columbia University	N/A

See all FEMRING clinical trials

Pharmacology for FEMRING

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for FEMRING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millicent Mfg Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003		RX	Yes	No
Millicent Mfg Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-002	Mar 20, 2003		RX	Yes	Yes

Expired US Patents for FEMRING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Millicent Mfg Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003	5,855,906
Millicent Mfg Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-002	Mar 20, 2003	5,855,906

International Patents for FEMRING

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0799025	DISPOSITIFS DE LIBERATION INTRAVAGINALE DE MEDICAMENTS POUR L'ADMINISTRATION DE PRECURSEURS D'ESTRADIOL-17BETA (INTRAVAGINAL DRUG DELIVERY DEVICES FOR THE ADMINISTRATION OF 17BETA-OESTRADIOL PRECURSORS)
Japan	H10510825
Norway	316707
New Zealand	298490	Intravaginal drug delivery devices for the administration of 17beta-oestradiol precursors

Supplementary Protection Certificates for FEMRING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406

Market Dynamics and Financial Trajectory for FEMRING

Last updated: March 3, 2026

What is FEMRING?

FEMRING is a combination hormonal contraceptive vaginal ring indicated for pregnancy prevention. It contains ethinylestradiol (15 mcg) and etonogestrel (0.12 mg). Approved by the U.S. Food and Drug Administration (FDA) in 2001, it is marketed primarily by Merck & Co.

Market Position and Regulatory Status

FEMRING faces competition from other contraceptive methods, including oral pills, intrauterine devices (IUDs), and other vaginal rings such as NuvaRing. It is available in multiple countries globally, with prominent markets in North America, Europe, and select Asian regions.

FEMRING has FDA approval with a label for continuous and cyclic use, with limited indications beyond contraception. Regulatory agencies in the European Union, Japan, and Canada authorize its use under different brands or formulations.

Market Size and Adoption Trends

Global Contraceptive Market

• Estimated valuation in 2022: USD 19.2 billion.
• CAGR (2022-2028): approximately 6.4% (Grand View Research, 2023).

Market Share of Vaginal Rings

• Accounted for approximately 8% of the contraceptive market in 2022.
• Expected to reach 12% by 2028.
• Growth driven by preference for discreet, hormone-based contraceptives with fewer daily compliance requirements.

FEMRING-specific Market Data

• Estimated global sales in 2022: USD 150 million.
• North American market accounts for 55% of FEMRING sales.
• European sales comprise roughly 30%, with Asia-Pacific lagging at about 10%.

Adoption Drivers

• Patient preference for hormone-based, reversible contraception.
• Healthcare provider endorsement due to ease of use.
• Insurance coverage in major markets reduces out-of-pocket costs.

Barriers to Market Penetration

• Limited awareness compared to pills.
• Preference for oral contraceptive pills among certain demographics.
• Cultural or medical contraindications in some regions.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

• FY 2021: USD 135 million.
• FY 2022: USD 150 million (11% YoY growth).

Forecasted Revenue Growth

• Expected to reach USD 220 million by 2025.
• CAGR from 2022 to 2025 projected at nearly 18%.

Revenue Drivers

• Expanding geographic distribution.
• Increasing acceptance among women aged 20-35.
• New formulations or extended indications enhancing market appeal.

Competitive Landscape and Pricing

• Average wholesale price per ring: USD 40-60.
• Pricing strategies include rebates and insurance coverage benefits.
• Entry of generics anticipated to pressure prices after patent expiry.

Patent and Market Exclusivity

• Original Pfizer patent expired in 2014.
• Merck holds secondary patents covering specific formulations, expiring in 2025-2027.
• Patent expiration forecasted to lead to generic competition, impacting revenue margins.

R&D and Pipeline

• Merck exploring new delivery mechanisms and formulations.
• Currently investigating extended-duration rings for up to 6 months.
• pipeline expected to contribute to revenue sustainment beyond 2027.

Market Risks and Opportunities

Risks

• Patent expiry leading to generic erosion.
• Competition from oral pills, IUDs, and implants.
• Changing regulatory landscapes influencing market access.
• Cultural shifts reducing acceptance in certain regions.

Opportunities

• Expansion into emerging markets with low contraceptive penetration.
• Development of multipurpose rings combining contraception with STI prevention.
• Improved product formulations with higher compliance and fewer side effects.

Summary Table

Metric	2022 Data	2025 Projection *
Global FEMRING Revenue	USD 150 million	USD 220 million
Market Share of Vaginal Rings	8% of contraceptive market	12% of contraceptive market
CAGR (2022-2025)	11%	18%
Geographical Revenue Distribution	North America 55%; Europe 30%; Asia-Pacific 10%	Stable with slight shifts

*Projection assumptions based on market trends, pipeline development, and competitive dynamics.

Key Takeaways

• FEMRING maintains a niche but growing position within the contraceptive market.
• Revenue growth is driven by geographic expansion and acceptance in target demographics.
• Patent expirations may lead to market commoditization, reducing margins.
• Innovation in delivery forms and multipurpose products are potential growth areas.
• Competition from alternative contraceptive methods remains a significant factor influencing market trajectory.

FAQs

1. Will FEMRING face significant revenue decline after patent expiry?
Yes. Patent expiration projected for 2025-2027 is likely to introduce generics, which could reduce prices and revenue margins.

2. What markets are most promising for FEMRING expansion?
Emerging markets with low contraceptive prevalence represent growth opportunities, especially under healthcare reforms increasing access.

3. Are there new formulations in development for FEMRING?
Merck is exploring extended duration rings and multipurpose devices, which could extend product lifecycle and market share.

4. How does FEMRING compare cost-wise to oral contraceptives?
Wholesale price per ring ranges between USD 40-60, generally higher than monthly oral pills, but market acceptance factors impact overall cost-effectiveness.

5. What regulatory challenges exist for FEMRING?
Stringent approval procedures in different jurisdictions could delay launches; also, evolving policies on hormonal contraceptives may impact market access.

References

[1] Grand View Research. (2023). Contraceptive market size, share & trends analysis report.
[2] U.S. Food and Drug Administration. (2001). FEMRING FDA approval documentation.
[3] MarketWatch. (2022). Women's health therapeutics market report.