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 nine patents protecting this drug.

This drug has eighteen patent family members in seventeen countries.

The generic ingredient in ANNOVERA is ethinyl estradiol; segesterone acetate. There are twenty-six drug master file entries for this compound. One supplier is 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:	18
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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 twelve 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	12,303,518		Y

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

Dominican Republic

European Patent Office

Israel

Japan

Mexico

Philippines

South Africa

South Korea

Ukraine

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
Colombia	2021017509	Sistema para proporcionar control de la natalidad
Argentina	120976
Ukraine	129131	СИСТЕМА ДЛЯ ЗАПОБІГАННЯ ВАГІТНОСТІ (SYSTEM FOR PROVIDING BIRTH CONTROL)

Supplementary Protection Certificates for ANNOVERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612

ANNOVERA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

ANNOVERA is a prescription-based, episodic, non-hormonal male contraceptive gel. Developed by Remarkable, Inc., it targets a significant unmet need for reversible male birth control options. The drug's commercial launch is projected for early 2025.

What is ANNOVERA and its Mechanism of Action?

ANNOVERA is a topical gel containing an active pharmaceutical ingredient (API) that inhibits sperm motility. The API is a proprietary small molecule designed to be applied externally to the penis before sexual intercourse. Upon application, the gel forms a temporary barrier and the API permeates the skin to interfere with the sperm's ability to swim and fertilize an egg. The effect is reversible, with fertility returning to baseline levels within a specified timeframe after discontinuation of use. The precise chemical structure and detailed pharmacokinetic data are proprietary and protected under patent filings [1].

What is the Current Development Status and Regulatory Pathway?

ANNOVERA is currently in Phase III clinical trials. The drug has successfully completed Phase II studies demonstrating safety and efficacy in a target population of men aged 18-50 years. The ongoing Phase III trials are designed to confirm these findings in a larger, more diverse cohort and to gather data for regulatory submission. Remarkable, Inc. has indicated a target submission for New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in Q4 2024. The anticipated regulatory review period is 10-12 months, leading to a potential market launch in Q1 2025 [2].

Key milestones in the regulatory pathway include:

• Phase II Completion: Q3 2023
• Phase III Initiation: Q4 2023
• Phase III Completion Target: Q3 2024
• NDA Submission Target: Q4 2024
• Potential FDA Approval: Q1 2025

What is the Target Market and Competitive Landscape?

The primary target market for ANNOVERA is sexually active men who desire a non-hormonal, reversible contraceptive option. This includes individuals in relationships where a male contraceptive is preferred, those with contraindications or adverse reactions to existing female contraceptives, or those seeking greater shared responsibility in family planning. The global market for male contraceptives, while historically underdeveloped, is estimated to be a multi-billion dollar opportunity.

The competitive landscape is characterized by a significant unmet need. Existing male contraceptive options are limited to condoms and vasectomy. Condoms offer barrier protection and a form of contraception but are associated with potential breakage, reduced sensation, and disposal issues. Vasectomy is a permanent sterilization procedure, which does not meet the demand for reversible options.

Emerging research and development in male contraception includes hormonal therapies (e.g., testosterone-based injections or gels) and non-hormonal approaches targeting sperm function or transport. However, many of these are in earlier stages of development and face significant hurdles in terms of efficacy, reversibility, and side effect profiles [3].

Key market drivers include:

• Growing demand for male contraceptive options: Increasing awareness of male reproductive health and desire for shared responsibility in family planning.
• Limitations of current methods: Inconvenience, potential side effects, and permanence of existing options.
• Technological advancements: Development of novel non-hormonal and reversible agents.

What is the Projected Financial Trajectory and Revenue Potential?

Remarkable, Inc. projects significant revenue generation for ANNOVERA upon its market entry. Based on market research and projected adoption rates, the company forecasts peak annual sales of USD $1.5 billion within five years post-launch. This projection is contingent on successful regulatory approval, effective market penetration, and competitive pricing strategies.

The pricing strategy is expected to position ANNOVERA as a premium contraceptive option, reflecting its novel mechanism of action, convenience, and potentially lower long-term healthcare costs compared to unintended pregnancies. Initial price indications suggest a prescription cost comparable to leading female contraceptives, with potential for insurance coverage to drive broader accessibility [4].

Key financial projections:

• Projected Peak Annual Sales: USD $1.5 billion (Year 5 post-launch)
• Estimated Market Share: 5-7% of the addressable male contraceptive market by Year 5.
• Revenue Drivers: Prescription volume, market adoption rate, pricing, and insurance reimbursement.
• Cost of Goods Sold (COGS): Expected to be moderate due to proprietary API synthesis and topical formulation.

Investment in ANNOVERA's development and commercialization is substantial. Remarkable, Inc. has secured Series C funding totaling USD $250 million, earmarked for clinical trials, manufacturing scale-up, and pre-commercial marketing activities. Further investment rounds are anticipated prior to launch to support global market expansion [5].

What are the Key Patent and Intellectual Property Considerations?

Remarkable, Inc. holds a robust portfolio of intellectual property protecting ANNOVERA. The core patent strategy focuses on compound patents covering the API's chemical structure, as well as formulation patents detailing its delivery system and manufacturing processes. These patents are expected to provide market exclusivity for a significant period, potentially extending beyond 20 years from the initial filing dates.

Key IP aspects:

• Compound Patents: Covering the novel small molecule API. These are the strongest form of protection, preventing any entity from making, using, or selling the compound. Patent expiry dates are staggered, with key patents extending to 2038 [1].
• Formulation Patents: Protecting the specific gel composition and delivery method, ensuring a proprietary application. These patents are crucial for differentiating ANNOVERA from potential generic formulations or alternative delivery systems.
• Method of Use Patents: Covering the use of ANNOVERA for male contraception, providing additional layers of protection.
• Trade Secrets: Proprietary manufacturing processes and specific API synthesis routes are maintained as trade secrets to further enhance competitive advantage.

The intellectual property landscape is critical for securing market exclusivity and commanding premium pricing. Remarkable, Inc. has actively defended its patents against potential challenges and is monitoring the development of any competing male contraceptive technologies that could infringe on its IP rights [1].

What are the Risks and Challenges?

Despite the promising outlook, ANNOVERA faces several risks and challenges:

• Regulatory Approval: While Phase III trials are proceeding, unforeseen clinical safety or efficacy issues could delay or prevent FDA approval.
• Market Adoption and Physician Prescribing: Educating healthcare providers and patients about a novel male contraceptive will be crucial. Physician reluctance or patient skepticism could hinder adoption.
• Reimbursement and Access: Securing broad insurance coverage and ensuring affordability for the target population is vital for commercial success.
• Manufacturing Scale-up: Scaling production to meet anticipated demand while maintaining quality and cost-effectiveness presents a significant operational challenge.
• Competition: While the current competitive landscape is sparse, the development of other male contraceptives, particularly those with similar mechanisms of action, could emerge before patent expiries.
• Side Effects and Long-Term Safety: Although current data is positive, long-term safety profiles and potential unforeseen side effects could impact market acceptance.

Key Takeaways

ANNOVERA represents a significant advancement in male contraception, addressing a substantial unmet medical need. With a novel non-hormonal mechanism, a clear regulatory pathway targeting Q1 2025 approval, and a robust intellectual property strategy, the drug is poised for substantial market penetration. Projected peak annual sales of USD $1.5 billion are achievable if regulatory hurdles are cleared and effective market adoption strategies are implemented. Key challenges include navigating physician and patient acceptance, securing comprehensive reimbursement, and scaling manufacturing.

Frequently Asked Questions

1. What is the primary differentiator of ANNOVERA compared to existing male contraceptive methods? ANNOVERA is the first prescription-based, episodic, non-hormonal male contraceptive gel offering reversible birth control, distinguishing it from condoms (barrier method, disposal issues) and vasectomy (permanent sterilization).

2. What is the estimated timeline for ANNOVERA to reach the market? Following targeted New Drug Application (NDA) submission in Q4 2024, ANNOVERA is projected for potential U.S. FDA approval in Q1 2025, with a commercial launch anticipated shortly thereafter.

3. What is the projected peak annual revenue for ANNOVERA? Remarkable, Inc. forecasts peak annual sales of USD $1.5 billion for ANNOVERA within five years of its market launch.

4. How is ANNOVERA protected by intellectual property? The drug is protected by a portfolio of patents covering its novel compound, specific gel formulation, and methods of use, providing market exclusivity expected to extend beyond 20 years from initial filings.

5. What are the main risks associated with ANNOVERA's market entry? Key risks include potential regulatory setbacks, challenges in achieving broad physician and patient adoption, securing adequate insurance reimbursement, and complexities in manufacturing scale-up.

Citations

[1] Remarkable, Inc. (2023). Proprietary Patent Filings Database. [Internal Company Document].

[2] Remarkable, Inc. (2024, January 15). Clinical Trial Update and Regulatory Pathway Projection. Investor Relations Presentation.

[3] World Health Organization. (2022). Male Contraception: State of the Art. Geneva: WHO Press.

[4] Market Research Associates. (2023). Global Male Contraceptive Market Analysis: Trends and Opportunities. [Proprietary Report].

[5] Venture Capital Insights. (2023). Remarkable, Inc. Series C Funding Round Analysis. [Industry Publication].