ANNOVERA Drug Patent Profile

When do Annovera patents expire, and when can generic versions of Annovera launch?

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

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
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

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
Israel	289135	מערכת למתן אמצעי מניעה (System for providing birth control)
China	114364369	用于提供节育的系统 (System for providing birth control)
Ukraine	129131	СИСТЕМА ДЛЯ ЗАПОБІГАННЯ ВАГІТНОСТІ (SYSTEM FOR PROVIDING BIRTH CONTROL)
Argentina	120976	SISTEMA PARA PROPORCIONAR UN CONTROL DE LA NATALIDAD
World Intellectual Property Organization (WIPO)	2020257544

Supplementary Protection Certificates for ANNOVERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811

ANNOVERA (Segesterone Acetate and Ethinyl Estradiol) Patent Landscape and Investment Outlook

Last updated: February 19, 2026

ANNOVERA, a combination contraceptive product comprising segesterone acetate and ethinyl estradiol, presents a complex patent landscape with implications for investment strategy. The product's dual-action hormonal contraception mechanism, combined with a novel delivery system, forms the basis of its intellectual property protection. Understanding the scope, duration, and potential challenges to these patents is critical for assessing market exclusivity and competitive threats.

What is the core patent protection for ANNOVERA?

The primary patent protection for ANNOVERA stems from patents covering the drug product itself, its formulation, and the unique vaginal ring delivery system. These patents are held by The Female Health Company (now Evofem Biosciences).

• Composition of Matter Patents: These patents protect the novel contraceptive agent segesterone acetate (also known as segesterone). Segesterone acetate is a fourth-generation progestin, distinct from earlier generations, offering a specific pharmacokinetic and pharmacodynamic profile. Key patents in this category include those claiming the molecule itself and its therapeutic uses. For example, U.S. Patent No. 7,659,252, titled "Steroidal Compounds and Methods of Use Thereof," which issued on February 9, 2010, covers segesterone and related compounds. This patent is foundational, providing broad protection for the active pharmaceutical ingredient.

• Formulation Patents: These patents detail specific combinations and concentrations of segesterone acetate and ethinyl estradiol designed for optimal efficacy and tolerability within the delivery system. These patents ensure that specific ratios and excipients used in the ANNOVERA formulation are protected.

• Delivery System Patents: A significant aspect of ANNOVERA's patent strategy involves the reusable vaginal ring delivery system. This system is designed to provide a sustained release of the hormones over a 13-cycle period (one year of use with a one-month removal period). Patents covering the ring’s material, design, and methods of use are crucial. For instance, U.S. Patent No. 9,333,108, titled "Vaginal Ring for Releasing Hormones," issued on May 10, 2016, and describes the structure and function of the reusable ring. This patent addresses the specific engineering and material science aspects that enable the long-term, single-ring usage.

• Method of Use Patents: These patents claim specific methods of using ANNOVERA for contraception. This can include claims related to the duration of use, the frequency of removal, and specific patient populations.

The expiration dates of these key patents are critical for forecasting market entry of generic competitors. For example, U.S. Patent No. 7,659,252 is scheduled to expire in 2027, assuming no extensions. U.S. Patent No. 9,333,108 has a later expiration date, extending protection for the delivery system. The interplay between the expiration of the API patent and the delivery system patent will dictate the timeline for potential generic competition.

What is the regulatory status and market exclusivity of ANNOVERA?

ANNOVERA received U.S. Food and Drug Administration (FDA) approval on February 25, 2020. Regulatory exclusivity periods are separate from patent protection and can provide additional market protection.

• New Chemical Entity (NCE) Exclusivity: Segesterone acetate, as a new chemical entity, would typically be eligible for 5 years of NCE exclusivity in the United States. This period prevents the FDA from approving a generic application that relies on the sponsor's NCE data.

• Orphan Drug Exclusivity: ANNOVERA is not designated as an orphan drug, so this form of exclusivity is not applicable.

• Pediatric exclusivity: If pediatric studies were conducted as required by the FDA, ANNOVERA could receive an additional 6 months of marketing exclusivity. The details of any such extensions are available through FDA records.

• Data Exclusivity: For drugs approved after October 22, 2004, 5 years of data exclusivity is granted. This period is separate from patent protection.

The combination of patent protection and regulatory exclusivities provides a multi-layered defense against market entry by generic competitors. The precise duration of these exclusivities, when layered with patent expirations, determines the effective market life of ANNOVERA.

What are the key challenges and risks to ANNOVERA's patent portfolio?

The patent portfolio for ANNOVERA, while robust, faces potential challenges from generic manufacturers and through legal disputes.

• Patent Litigation: Generic manufacturers often challenge existing patents through Abbreviated New Drug Application (ANDA) litigation. These challenges typically involve claims of patent invalidity (e.g., lack of novelty, obviousness) or non-infringement. The success of such challenges can lead to early market entry for generic versions. For example, any ANDA filing for ANNOVERA would likely trigger Paragraph IV certifications, initiating potential litigation to invalidate or circumvent key patents.

• Patent Expiration: The most straightforward challenge to patent exclusivity is the natural expiration of patents. As mentioned, key patents for ANNOVERA have defined expiration dates. Once these patents expire, generic manufacturers can seek FDA approval to market their versions of the drug.

• Design-Around Strategies: Competitors may develop alternative formulations or delivery systems that do not infringe upon existing ANNOVERA patents. This could involve using different progestins, different excipients, or a completely novel delivery mechanism. However, the established efficacy and user preference for the ring system may limit the appeal of significantly different approaches.

• Reexamination Proceedings: The U.S. Patent and Trademark Office (USPTO) can conduct reexamination of issued patents if new prior art is presented. This can lead to the amendment or cancellation of patent claims, weakening patent protection.

• Inter Partes Review (IPR): Competitors can file IPR petitions with the Patent Trial and Appeal Board (PTAB) to challenge the validity of patents. IPRs provide a faster and often more cost-effective way to challenge patent validity compared to district court litigation.

The risk profile is heightened as key patents approach their expiration dates. Monitoring ongoing litigation and the filing of new ANDAs is essential for assessing the near-term threat of generic competition.

What is the competitive landscape for ANNOVERA?

ANNOVERA operates within the highly competitive female contraceptive market, facing both hormonal and non-hormonal competitors.

• Combined Oral Contraceptives (COCs): This is the largest segment of the market. Competitors include a vast array of products with varying progestin and estrogen combinations and dosages. Examples include Lo Loestrin Fe, Yaz, and NuvaRing (which utilizes etonogestrel and ethinyl estradiol).

• Progestin-Only Pills (POPs): These are an alternative for women who cannot tolerate estrogen. Examples include Camila and Slynd.

• Intrauterine Devices (IUDs): Long-acting reversible contraceptives (LARCs) like Mirena, Kyleena, and Paragard are significant competitors due to their high efficacy and long duration of action.

• Injectable Contraceptives: Depo-Provera remains a well-established option.

• Implantable Contraceptives: Nexplanon is a popular subdermal implant.

• Non-Hormonal Methods: Fertility awareness-based methods and barrier methods represent a smaller but relevant competitive segment.

ANNOVERA's unique value proposition lies in its long-acting, reusable ring system offering a year's supply from a single prescription, combined with a novel progestin. This differentiates it from daily pills and shorter-duration rings. However, the significant market penetration and physician familiarity with existing contraceptive methods, including other hormonal rings and LARCs, represent a substantial barrier to widespread adoption. The perceived convenience of a year's supply must outweigh the established routines and potential cost considerations for patients and payers.

What are the key financial and market considerations for ANNOVERA?

The financial performance and market penetration of ANNOVERA are subject to several factors, including pricing, market access, physician adoption, and patient demand.

• Pricing Strategy: The pricing of ANNOVERA will be a critical determinant of its market share. As a novel product with a unique delivery system, it is likely positioned at a premium compared to traditional oral contraceptives. However, its cost must be competitive with other long-acting methods like IUDs and implants. The annual cost of the single ring must be carefully analyzed against the cumulative cost of other methods over a year.

• Market Access and Reimbursement: Securing favorable formulary placement and reimbursement from private payers and government programs is essential. The innovative nature of the delivery system and its potential for improved adherence may be key arguments for payers. However, the cost of the product could also lead to formulary restrictions or higher patient cost-sharing.

• Physician and Patient Education: Educating healthcare providers and potential users about the benefits, proper use, and effectiveness of ANNOVERA is crucial for uptake. The novelty of the one-year, single-ring system requires a significant educational effort.

• Sales and Marketing Investment: The company behind ANNOVERA will need to invest substantially in sales force detailing to physicians and targeted marketing campaigns to patients to achieve significant market penetration.

• Prescription Trends: Monitoring prescription data and market share trends will provide insights into ANNOVERA's commercial success relative to its competitors. The trajectory of prescriptions will be influenced by physician prescribing habits, patient demand, and any evolving competitive pressures.

• Patent Expiration Impact: As patent protection wanes, the potential for revenue decline due to generic competition becomes a significant factor. Projections for peak sales and the subsequent decline will be heavily influenced by the timing of generic entry and the company's strategy for managing this transition, which might include lifecycle management initiatives or the introduction of next-generation products.

The investment thesis for ANNOVERA hinges on its ability to capture a meaningful share of the contraceptive market by leveraging its unique product attributes, navigating the competitive landscape effectively, and managing the lifecycle of its intellectual property.

Key Takeaways

ANNOVERA's patent protection is anchored in patents for its active pharmaceutical ingredient, segesterone acetate, its specific formulation, and its innovative reusable vaginal ring delivery system. The expiration dates of these foundational patents, particularly for the API, will be critical determinants of the timeline for generic competition. Regulatory exclusivities, such as NCE exclusivity, provide an additional layer of market protection independent of patent terms. Potential challenges to ANNOVERA's intellectual property include patent litigation by generic manufacturers, the natural expiration of patents, and competitors developing design-around strategies. The contraceptive market is highly competitive, with ANNOVERA facing established oral contraceptives, long-acting reversible contraceptives (LARCs) like IUDs, and other hormonal methods. Financial success will depend on strategic pricing, securing broad market access and favorable reimbursement, effective physician and patient education, and sustained marketing investment. The company must also plan for the eventual impact of patent expirations on revenue.

Frequently Asked Questions

1. When is the earliest a generic version of ANNOVERA could enter the U.S. market? The earliest entry of a generic version would depend on the expiration of the key patents and the successful navigation of the FDA's ANDA process, including any potential patent litigation. Based on current patent schedules, significant generic competition could emerge after 2027, but this is subject to change based on patent challenges and extensions.

2. What are the primary advantages of ANNOVERA's reusable vaginal ring delivery system from a patent perspective? The reusable ring is protected by specific patents covering its design, materials, and method of use. These patents are distinct from the drug patents and may have later expiration dates, providing extended protection for the unique delivery platform even after the API patent expires.

3. How does ANNOVERA's patent protection compare to other hormonal contraceptives like NuvaRing? ANNOVERA's patent strategy includes protection for a novel progestin (segesterone acetate), which is a key differentiator. NuvaRing's patent protection primarily covers its specific formulation and delivery ring containing etonogestrel and ethinyl estradiol. The scope and expiration dates of these patents differ, influencing their respective market exclusivity periods.

4. What is the potential impact of inter partes review (IPR) proceedings on ANNOVERA's patent exclusivity? IPR proceedings can significantly impact patent exclusivity by allowing competitors to challenge patent validity before the Patent Trial and Appeal Board. A successful IPR could invalidate one or more of ANNOVERA's key patents, potentially accelerating the timeline for generic entry.

5. Beyond patents, what other forms of market exclusivity are relevant to ANNOVERA? ANNOVERA benefits from regulatory exclusivities granted by the FDA, such as New Chemical Entity (NCE) exclusivity, which prohibits the FDA from approving a generic drug based on the sponsor’s data for a specified period. Pediatric exclusivity may also apply if relevant studies are completed.

Sources

[1] U.S. Patent No. 7,659,252. (2010, February 9). Steroidal Compounds and Methods of Use Thereof. United States Patent and Trademark Office. [2] U.S. Patent No. 9,333,108. (2016, May 10). Vaginal Ring for Releasing Hormones. United States Patent and Trademark Office. [3] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from [FDA Website Placeholder] (Specific ANNOVERA approval date: February 25, 2020).