ANNOVERA Drug Patent Profile

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

Annovera is a drug marketed by Mayne Pharma and is included in one NDA. There are eight patents protecting this drug.

This drug has sixteen patent family members in sixteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Annovera

Annovera was eligible for patent challenges on August 10, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 21, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ANNOVERA

International Patents:	16
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	2
Drug Prices:	Drug price information for ANNOVERA
What excipients (inactive ingredients) are in ANNOVERA?	ANNOVERA excipients list
DailyMed Link:	ANNOVERA at DailyMed

See drug prices for ANNOVERA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ANNOVERA

Constraining patent/regulatory exclusivity:

10,918,649

NDA:

209627

Dosage:

RING;VAGINAL

^*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 ANNOVERA

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

Sponsor	Phase
TherapeuticsMD	Phase 1

See all ANNOVERA clinical trials

Pharmacology for ANNOVERA

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ANNOVERA

ANNOVERA is protected by eleven US patents.

This potential generic entry date is based on patent 10,918,649.

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
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,632,066
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	11,850,251
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	11,529,308		Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,780,047
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,765,628

International Patents for ANNOVERA

When does loss-of-exclusivity occur for ANNOVERA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

European Patent Office

Israel

Japan

Mexico

South Africa

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ANNOVERA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2020294780
Israel	289135	מערכת למתן אמצעי מניעה (System for providing birth control)
Mexico	2022000047	SISTEMA PARA PROPORCIONAR CONTROL DE LA NATALIDAD. (SYSTEM FOR PROVIDING BIRTH CONTROL.)
South Africa	202110288	SYSTEM FOR PROVIDING BIRTH CONTROL
Ukraine	129131

Supplementary Protection Certificates for ANNOVERA

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
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON

Market Dynamics and Financial Trajectory for Annovera

Introduction

Annovera, a revolutionary vaginal contraceptive system developed by the Population Council and commercialized by TherapeuticsMD, has been making significant waves in the women’s health market since its FDA approval in August 2018. Here, we delve into the market dynamics and financial trajectory of Annovera, highlighting its unique features, market reception, and financial performance.

Unique Features and Market Positioning

Annovera is the first and only contraceptive that provides an entire year of protection against unintended pregnancy while being fully under a woman’s control. It is a soft, reusable flexible silicone ring that combines segesterone acetate and ethinyl estradiol, inhibiting ovulation for up to 13 menstrual cycles or one full year[4].

This product fills a critical gap in the contraceptive market by offering a long-lasting, reversible, and procedure-free option, which is particularly appealing in low-resource settings due to its lack of refrigeration requirements.

Market Reception and Adoption

Since its approval, Annovera has been well-received by both healthcare providers and patients. The product has been adopted by over 15,000 healthcare providers (HCPs) as of the third quarter of 2022, with more than 1,500 new prescribers added during that period alone[2].

Patient satisfaction is also high, with nearly 9 in 10 women surveyed expressing satisfaction with Annovera in terms of convenience, ease of use, and comfort. The product’s effectiveness, with a Pearl Index of 2.98 and an efficacy rate of 97.3% when used as directed, further solidifies its position in the market[4].

Financial Performance

The financial performance of Annovera has been closely monitored since its commercial launch. Here are some key financial highlights:

Revenue

• In the third quarter of 2022, Annovera generated net product revenue of $10.4 million, which was a decrease of $1.4 million compared to the third quarter of 2021. However, total prescriptions for Annovera grew by 10% year-over-year[2].
• For the nine months ended September 30, 2022, Annovera’s net product revenue was $37.2 million, indicating a steady stream of revenue despite some quarterly fluctuations[2].

Prescription Volume

• Approximately 9,200 Annovera prescriptions were dispensed to patients during the third quarter of 2022, reflecting ongoing demand for the product[2].

Cost and Manufacturing Efficiency

• The approval of a supplemental New Drug Application (sNDA) in 2022 allowed for more efficient manufacturing and reduced batch rejections, enabling the company to better meet customer demand. This approval was expected to add approximately 7,000 additional rings to the supply chain[1].

Market Impact and Competitive Landscape

Annovera’s approval has significant implications for the contraceptive market, particularly under the Affordable Care Act (ACA), which may require private health plans to cover Annovera with no patient out-of-pocket costs[5].

The U.S. market for prescription contraceptives is substantial, generating over $5 billion in net sales in 2017. Annovera’s unique features position it to capture a significant share of this market, especially among women seeking long-lasting, reversible, and convenient contraceptive options[5].

Challenges and Future Outlook

Despite its positive reception, Annovera faces several challenges, including:

Regulatory and Safety Considerations

• The FDA has conducted reviews of adverse event reports, particularly in pediatric patients, but no new safety signals or increased severity of labeled adverse events have been identified[3].

Financial and Operational Challenges

• TherapeuticsMD has faced inventory issues and reduced operating expenses, but the company has made strides in resolving these issues and ensuring a fully stocked wholesale network[2].

Competitive Market

• The contraceptive market is highly competitive, with various products available, including other hormonal contraceptives and non-hormonal options. However, Annovera’s unique features and high patient satisfaction rates position it favorably in this competitive landscape.

Conclusion

Annovera has carved out a niche in the contraceptive market with its innovative design and user-friendly features. While it faces some financial and operational challenges, the product’s adoption and revenue growth indicate a promising future.

Key Takeaways

• Unique Product: Annovera is the first one-year contraceptive fully under a woman’s control, combining segesterone acetate and ethinyl estradiol.
• Market Reception: High patient satisfaction and adoption by over 15,000 healthcare providers.
• Financial Performance: Steady revenue stream with $10.4 million in Q3 2022 and 10% year-over-year prescription growth.
• Regulatory Impact: Potential for full coverage under the Affordable Care Act.
• Challenges: Inventory issues, regulatory reviews, and competitive market dynamics.

FAQs

Q1: What is Annovera and how does it work? Annovera is a vaginal contraceptive system that combines segesterone acetate and ethinyl estradiol in a reusable silicone ring. It is inserted into the vagina for 21 days and removed for 7 days each cycle to provide contraception for up to one year.

Q2: When was Annovera approved by the FDA? Annovera was approved by the FDA on August 10, 2018.

Q3: How effective is Annovera in preventing pregnancy? Annovera is 97.3% effective in preventing pregnancy when used as directed, with a Pearl Index of 2.98.

Q4: What are the common side effects of Annovera? The most common side effects of Annovera include headache and nausea, similar to other combined hormonal contraceptives.

Q5: Is Annovera covered under the Affordable Care Act? Annovera’s approval potentially requires private health plans to cover it with no patient out-of-pocket costs under the Affordable Care Act.

Sources

1. TherapeuticsMD Receives U.S. Food and Drug Administration (FDA) Approval for sNDA for ANNOVERA - TherapeuticsMD.
2. TherapeuticsMD Announces Third Quarter 2022 Financial Results - TherapeuticsMD.
3. FDA Adverse Event Reporting System (FAERS) Reports for Annovera in Pediatric Patients - FDA.
4. FDA Approves the First One-Year Contraceptive Fully under a Woman’s Control - Population Council.
5. TherapeuticsMD Announces FDA Approval of ANNOVERA - BioSpace.