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 is one drug master file entry 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

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.

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
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes

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
Argentina	120976	SISTEMA PARA PROPORCIONAR UN CONTROL DE LA NATALIDAD
Australia	2020294780	System for providing birth control
Brazil	112021025853	Sistema para fornecimento de controle de natalidade
Canada	3141077	SYSTEME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL)
Chile	2021003410	Sistema para proporcionar control de la natalidad
China	114364369	用于提供节育的系统 (System for providing birth control)

Supplementary Protection Certificates for ANNOVERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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

Last updated: July 26, 2026

ANNOVERA market dynamics and financial trajectory: pricing, uptake, exclusivity, and generic/biosimilar risks

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) has launched into a highly regulated, category-differentiated space with pricing and reimbursement still determining near-term unit economics. The revenue trajectory is driven by (1) adoption among commercially insured and managed Medicaid populations, (2) persistence and repeat-cycle retention in the first 6 to 12 months post-launch, and (3) competitive pressure from other long-acting contraception modalities (PITC, LNG-IUDs, implants) and from branded oral contraception. Near-term financial risk is less about direct therapeutic-class competition and more about payer access, formulary placement, and patient acquisition economics relative to monthly oral comparators.

Patent and exclusivity structure is central to medium-term revenue sustainability because ANNOVERA is a combination hormonal product with a device-based delivery system. Any erosion from “authorized generic” dynamics (unlikely without FDA/brand strategy) or from generic entry (through ANDA or 505(b)(2) reliance) would hinge on Orange Book patent carve-outs and Paragraph IV incentives.

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What is ANNOVERA’s commercial positioning and market dynamics in contraception?

ANNOVERA’s commercial model is “1 device, repeated cycles” rather than daily dosing. That changes marketing and contracting mechanics versus oral contraceptives and affects payer behavior.

Key demand drivers

• Adherence relief versus daily oral contraception reduces missed-dose risk and supports payer acceptance if outcomes and satisfaction are demonstrated.
• Cycle-based convenience aligns with patient preferences that favor predictable schedules and reduces clinic visits tied to other long-acting methods.
• Provider adoption depends on office workflow: training for vaginal placement/removal, troubleshooting, and patient selection.

Key payer and access drivers

• Formulary placement: success depends on preferred contraceptive tiers and plan-specific “medical vs pharmacy” handling.
• Prior authorization (PA): common for higher-cost contraception when payers require documentation of failure/intolerance to lower-cost options.
• Step therapy: may be applied through coverage policies that start with oral contraceptives or lower-cost long-acting methods.

Competitive pressure map

• Close substitutable options: combined oral contraceptives, vaginal ring, patch, and long-acting reversible contraception (LNG-IUDs, copper IUDs, implants).
• Indirect substitutes: condoms, fertility awareness methods, and permanent methods where counseling steers away from systemic hormone exposure.

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How does ANNOVERA pricing work: wholesale acquisition cost, patient out-of-pocket, and net price?

ANNOVERA’s financial trajectory is highly sensitive to net price, not list price. In branded contraception, net pricing is shaped by rebates, commercial contracts, and PA outcomes.

Commercial pricing dynamics that usually govern trajectory

• Rebate intensity: higher where managed care contracts demand discounts to win formulary position.
• Copay strategy: copay cards can accelerate uptake early but can also reduce measurable “true” conversion once patient support ends.
• Medicaid/HMO reimbursement: can be decisive since contraception demand is broadly distributed across high-benefit patients who are most exposed to non-preferred tiers.

Revenue levers

• Unit volume (devices dispensed per month) and effective cycles per device.
• Retention through repeat-year use. In device-based contraception, churn and discontinuation lower cumulative revenue per initial pharmacy acquisition.
• Claims rate and rejection patterns: PA and plan policy rejections can show up quickly in pharmacy claims data.

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What is ANNOVERA’s sales trajectory and financial performance outlook?

A credible forward view of ANNOVERA’s financial trajectory depends on early-cycle persistence and payer penetration. The trajectory typically falls into three phases in specialty-and-device branded launches:

1. Launch ramp: driven by provider training, awareness, and copay support where available.
2. Managed access stabilization: growth depends on PA criteria and formulary placement permanence.
3. Competitive repricing and channel optimization: brand-to-generic substitution is limited unless a true generic enters, but internal competition between contraception products can pressure net price.

What to watch for in financial metrics

• Script velocity (new starts per month).
• Net-to-gross ratio (commercial discounting).
• Duration on therapy (repeat cycles).
• Channel mix shift: commercial vs government (Medicaid, dual-eligible) because government net prices often differ sharply.

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What patents protect ANNOVERA and how do they affect revenue durability?

ANNOVERA’s revenue durability is tied to (1) composition and combination IP, (2) method-of-use and device system patents, and (3) formulation and manufacturing patents that block “design-around” replacements.

Patent estate coverage categories

• Composition-of-matter (active ingredients and combinations)
• Delivery system/device patents (vaginal system construction and release mechanics)
• Method-of-use (contraceptive regimen, cycle-based use)
• Manufacturing/process (device assembly, coating, matrix/release controls)
• Formulation (drug load, excipients, release rate design)

Why this matters commercially

Even if a generic can match actives, device patents often block approval via bioequivalence-only strategies. For a combination hormonal vaginal system, the strongest “generic friction” is usually device release and physical system performance rather than only chemical identity.

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When does ANNOVERA lose exclusivity and when could generic entry occur?

Exclusivity and patent expiration drive the timing of generic revenue erosion. The near-term risk profile depends on whether patents are Orange Book-listed for the approved NDA and whether they cover core claims that would be required for ANDA approval.

Revenue timeline mechanics

• Patent expiration: first potential timepoint for generic entry.
• Exclusivity end dates: additional barriers if statutory or regulatory exclusivities remain.
• Paragraph IV incentives: strongest when at least one patent is perceived as vulnerable and the first-filer settlement window makes economic sense.

Generic entry scenarios

• ANDA with Paragraph IV: potential if Orange Book patents are challengeable and a device-based system can be engineered to show required performance.
• 505(b)(2) or formulation-driven approaches: could introduce “next-gen” branded/generic-adjacent competitors without full device replication, but they still face device IP barriers.

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What is the Orange Book status of ANNOVERA and which patents are likely listed?

The Orange Book status is the practical map of what must be cleared to enter the market. For a device-based combination product like ANNOVERA, Orange Book-listed patents commonly include method-of-use and device/formulation-related patents.

How to read the listing for market impact

• Core patents: those that are expected to be difficult to design around and likely to remain in force.
• Bottleneck patents: patents that cover unique aspects of the system and are essential for approval.
• Expiring patents: those that reduce the patent “thickness” and increase Paragraph IV incentives.

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How strong is the patent estate for ANNOVERA compared with other contraceptive technologies?

For long-term revenue protection, “strength” is not just legal validity. It is the ability to block practical design-arounds that a potential generic would need.

Comparative strength factors

• Number of Orange Book listings: thicker estates usually translate into more entry friction.
• Claim breadth: broader device and formulation claims increase the probability of staying barriers to replication.
• Expiration dispersion: if key patents expire close together, generic entry risk rises around the same window.
• Litigation history: prior enforcement can indicate willingness to defend and can reveal claim vulnerabilities.

Market implication

If device and formulation patents dominate the estate, generic entry will likely be delayed relative to oral-only analogs, because engineering parity for a vaginal system is harder than matching a tablet.

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What patent litigation affects ANNOVERA and what settlements could signal generic timing?

Patent litigation drives entry timing through:

• Injunction risk: delays at-launch.
• 30-month stay: practical delay after Paragraph IV filings.
• Settlement agreements: can define “design around dates,” launch dates, and licensing scopes.

Settlement-driven entry

If the brand settles, generic entry can become predictable even if patents remain. The market impact is immediate once launch date is contractually defined.

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How could a Paragraph IV challenge to ANNOVERA change the competitive landscape?

A Paragraph IV filing changes brand economics by:

• accelerating discovery and defense spend,
• introducing market uncertainty and payer renegotiation behavior, and
• increasing likelihood of early launch readiness by challengers.

Typical competitive consequences

• Brand promotional adjustments: increased payer pull-through to maximize volume before stay windows.
• Generic “option value”: challengers may stock supply and align launch plans to settlement triggers.
• Pricing discipline: brands can accept lower net margins temporarily if volume preservation is prioritized.

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What generic entry risks exist for ANNOVERA: device replication, bioequivalence, and regulatory pathway?

For ANNOVERA-style systems, generic risk is shaped by technical and regulatory constraints.

Device replication barriers

• Release profile matching: maintaining contraceptive hormone delivery kinetics across wear time.
• System geometry and retention: changes can affect comfort and real-world adherence.
• Stability and shelf life: device-based systems can be harder to reproduce.

Regulatory pathway friction

• ANDA feasibility depends on whether a generic can satisfy the required performance characteristics while staying within permissible design and formulation limits.
• Labeling and clinical outcomes: if pivotal data are required for critical performance attributes, approval timelines lengthen.

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How does ANNOVERA compare with competing contraceptives on market adoption and differentiation?

ANNOVERA’s differentiator is “repeat-cycle vaginal system.” Financially, differentiation matters because contraception demand is broad but conversion is constrained by familiarity and access.

Comparison dimensions that affect buying

• Dosing frequency and adherence: daily vs cyclic.
• Side-effect profiles: patient tolerability drives persistence.
• Provider familiarity: familiarity with IUD/implant workflows versus vaginal system insertion/removal.
• Insurance coverage: net price impacts the payer decision more than clinical nuance once efficacy is accepted.

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What is ANNOVERA’s expected biosimilar risk profile?

ANNOVERA is a small-molecule hormone product delivered via a device. Biosimilar pathways do not apply. Competitive entry risk is from generics and potentially alternative branded formulations or device systems.

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What commercialization strategy most influences ANNOVERA’s future revenue?

ANNOVERA’s financial trajectory most likely depends on:

• Managed care wins through formulary inclusion and reduced PA burden.
• Provider channel penetration: ensuring OB-GYN and women’s health providers routinely include ANNOVERA in contraception counseling.
• Persistence-focused support: patient education on insertion/removal, troubleshooting, and expected cycle behavior.

High-leverage program design

• Reduce PA friction with evidence bundles that match payer medical policy.
• Optimize starter-to-repeat conversion using refill incentives where permitted.
• Track discontinuation reasons and align patient support scripts to common failure modes.

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Key Takeaways

• ANNOVERA’s revenue trajectory is driven by payer access and persistence, not only by clinical differentiation versus daily oral contraceptives.
• Device-based IP typically creates additional generic entry friction versus oral-only products, extending revenue durability if the patent estate is device- and formulation-heavy.
• Competitive pressure is likely to play out first through net pricing and coverage tiering rather than immediate generic erosion.
• Patent expiration, Orange Book listing breadth, and potential Paragraph IV events define the medium-term risk window more than therapeutic-class competition.

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FAQs

1. What factors most influence ANNOVERA net pricing and pharmacy reimbursement outcomes?
2. How do prior authorization and formulary tier placement affect early ANNOVERA adoption?
3. Which patent categories for a vaginal contraceptive system typically create the biggest generic design-around barriers?
4. What indicators show whether a contraceptive product is reaching persistence and repeat-cycle retention?
5. How does settlement timing after a Paragraph IV filing usually affect generic launch dates in branded contraception?

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References

1. [No cited sources provided.]

DrugChatter Q&A for ANNOVERA

If annovera ring is put in fridge is it still effective today?
Annovera patent expiration?
How much is annovera without insurance?
Is annovera a hormonal contraceptive?
Can annovera be used while breastfeeding?