FEMRING Drug Patent Profile

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

Femring is a drug marketed by Millicent 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:	13
Clinical Trials:	1
Patent Applications:	536
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 Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003		RX	Yes	No
Millicent 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 Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003
Millicent Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-002	Mar 20, 2003

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)
Finland	119414
Israel	116433	INTRAVAGINAL DRUG DELIVERY DEVICES FOR THE ADMINISTRATION OF 17β-OESTRADIOL PRECURSORS
Norway	316707
South Africa	9510787

Supplementary Protection Certificates for FEMRING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
2782584	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
2782584	LUC00245	Luxembourg		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208

Market Dynamics and Financial Trajectory for Femring

Overview of Femring

Femring, a vaginal ring containing estradiol acetate, is a medication used to treat moderate to severe menopausal symptoms, including vaginal atrophy and hot flashes, in postmenopausal women. Here’s a detailed look at the market dynamics and financial trajectory of Femring.

Market Segmentation and Competition

Types of Postmenopausal Vaginal Atrophy Drugs

The market for postmenopausal vaginal atrophy drugs is segmented into various types, including vaginal gels, creams, tablets, rings, and patches. Femring falls under the vaginal ring category, competing with other products like Estring and Estrace Cream[4].

Key Competitors

Femring competes with products from several major pharmaceutical companies, including Pfizer (Estring), Allergan (Estrace Cream), Novo Nordisk (Vagifem), and others like Actavis plc, Endoceutics Inc., and Teva Pharmaceuticals Ltd.[4].

Pricing and Cost Considerations

Current Pricing

The cost of Femring is significant, with a single vaginal ring (0.05 mg/day or 0.10 mg/day) priced around $811 to $863, depending on the dosage and pharmacy[2].

Impact of Generics

Unlike some other estradiol products, Femring does not yet have a generic version available. This lack of generic competition contributes to its higher pricing. However, the presence of generics in other segments of the market, such as those for Vagifem, can influence pricing dynamics and patient choices[1][2].

Insurance and Patient Assistance Programs

Insurance Coverage

Femring is typically covered by most insurance plans, but patients may still face high out-of-pocket costs due to higher deductibles and copays. For eligible patients, Pfizer offers patient assistance programs and co-pay savings cards, which can reduce the cost to as little as $25 for each 90-day prescription[5].

Patient Assistance

For patients struggling to afford Femring, Pfizer provides patient assistance programs. These programs can help make the medication more accessible, although they are not available for patients whose prescriptions are paid for by federal, state, or other government-funded programs[5].

Market Growth and Forecast

Global Market Trends

The global postmenopausal vaginal atrophy drugs market is experiencing significant growth. The market size is expected to increase from 2024 to 2031, driven by increasing awareness and the expanding aging population. The vaginal gels segment, in particular, is expected to grow at a significant CAGR during the forecast period[4].

Regional Analysis

The market is segmented into regions such as North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region has its own growth rate and market share, with North America and Europe being significant contributors to the global market[4].

Financial Performance and Revenue

Revenue Generation

Femring, as a brand-name drug, generates substantial revenue for its manufacturer. While exact figures for Femring alone are not provided, the overall market for postmenopausal vaginal atrophy drugs is substantial, with key players like Pfizer and Allergan reporting significant sales from their respective products[1][4].

Impact of Patent Loss and Generic Competition

The loss of patent protections for other estradiol products, such as Estrace Cream, has led to increased generic competition, which can impact the pricing and market share of brand-name drugs like Femring. However, as long as Femring remains without a generic alternative, it is likely to maintain its market position and revenue stream[1].

Safety and Efficacy Considerations

Safety Profile

Femring, like other estrogen therapies, comes with several safety considerations, including an increased risk of endometrial cancer, breast cancer, and thromboembolic events. Patients must be started on the lowest dose and monitored closely for any adverse effects[3][5].

Efficacy

Femring is effective in reducing moderate to severe menopausal symptoms, including vaginal atrophy and hot flashes. It is designed to be used for 3 months continuously, after which it is replaced with a new ring[5].

Patient and Market Perception

Taboo and Awareness

The lack of public outcry over the pricing of estradiol products, including Femring, can be attributed to the taboo surrounding women's sexual health issues. This stigma can affect market dynamics and patient advocacy, making it less likely for patients to publicly demand lower prices[1].

Patient Resort to Alternatives

Due to high costs, some patients resort to buying estradiol products from overseas outlets, where prices can be significantly lower. This trend highlights the need for more affordable options within the domestic market[1].

Key Takeaways

• Pricing and Cost: Femring is a high-priced medication, with costs ranging from $811 to $863 per ring, and lacks generic competition.
• Insurance and Assistance: Covered by most insurance plans, but patients may face high out-of-pocket costs; patient assistance programs are available.
• Market Growth: The global postmenopausal vaginal atrophy drugs market is growing, driven by an aging population and increasing awareness.
• Safety and Efficacy: Femring is effective but comes with significant safety considerations, including increased risks of cancer and thromboembolic events.
• Patient Perception: The taboo surrounding women's sexual health issues affects market dynamics and patient advocacy.

FAQs

Q: What is Femring used for?

Femring is used to treat moderate to severe menopausal symptoms, including vaginal atrophy and hot flashes, in postmenopausal women.

Q: How much does Femring cost?

The cost of Femring is around $811 to $863 for a single vaginal ring, depending on the dosage and pharmacy.

Q: Is Femring covered by insurance?

Yes, Femring is typically covered by most insurance plans, but patients may still face high out-of-pocket costs.

Q: Are there any patient assistance programs for Femring?

Yes, Pfizer offers patient assistance programs and co-pay savings cards to help reduce the cost of Femring.

Q: What are the potential side effects of Femring?

Femring can have serious side effects, including increased risks of endometrial cancer, breast cancer, and thromboembolic events, as well as less serious side effects like headache, breast tenderness, and vaginal yeast infections.

Sources

1. FiercePharma: "Women's hormone drug prices have climbed for years, but there hasn't been a controversy. Why?"
2. Drugs.com: "Femring Prices, Coupons, Copay Cards & Patient Assistance"
3. FDA: "Femring® (estradiol acetate vaginal ring) - accessdata.fda.gov"
4. Cognitive Market Research: "Global Postmenopausal Vaginal Atrophy Drugs Market Report 2024"
5. Femring.com: "Femring® (estradiol acetate vaginal ring) - Patient Pamphlet"