United States Patent 10,632,066: Claim Scope, Annovera Protection, and Patent Landscape

U.S. Patent No. 10,632,066 protects a specific clinical-use regimen for the Annovera vaginal contraceptive system, not segesterone acetate, ethinyl estradiol, or vaginal rings in the abstract. The patent requires the patented silicone ring, exact drug loads, defined release rates, a 21-day insertion period, a five- to seven-day storage interval, repeat use for as many as 13 cycles, and supplemental non-estrogen contraception after more than two cumulative hours outside the vagina.

The patent is strategically important because a generic or follow-on product could practice the claims through labeling and prescribing instructions even if its formulation or manufacturing process differs. The principal enforcement risk is therefore method-of-use infringement tied to a product that reproduces the patented dosing and removal instructions.

What drug and product does U.S. Patent 10,632,066 protect?

Patent 10,632,066 covers the reusable vaginal contraceptive system marketed as Annovera, which contains segesterone acetate and ethinyl estradiol. The product was approved by the FDA on Aug. 10, 2018, under NDA 209306.[1]

The claimed system has the following required characteristics:

Claim element	Required limitation
Dosage form	Silicone elastomer vaginal ring
Internal structure	Ring body with two channels
Drug reservoirs	First and second cores placed in the channels
Segesterone acetate	103 mg, distributed throughout both cores
Ethinyl estradiol	17.4 mg, contained in one of the cores
Average release	Approximately 0.15 mg/day segesterone acetate and 0.013 mg/day ethinyl estradiol
Initial use	Insertion on menstrual cycle day 2, 3, 4, or 5
First use period	21 days
Removal interval	Five to seven days, including the removal date
Repeat use	Up to 13 28-day cycles
Removal event	More than two cumulative hours outside the vagina
Backup contraception	Non-estrogen contraception for seven days after reinsertion in specified circumstances
Timing	Initial insertion at approximately the same time of day in subsequent cycles

The patent does not broadly claim every segesterone acetate contraceptive, every vaginal ring, or every reusable hormonal ring. Each limitation must be satisfied for literal infringement of an independent claim.

What are the independent claims in Patent 10,632,066?

Claims 1 and 6 are the independent claims. They cover related but materially different methods.

Claim 1: first-cycle removal and reinsertion regimen

Claim 1 requires:

Initial insertion on day 2, 3, 4, or 5 of the menstrual cycle.
Use of the specified ring for a 21-day first period.
Removal for more than two cumulative hours during that period.
Reinsertion after removal.
Use of a non-estrogen secondary contraceptive for seven days after reinsertion.
Removal on the day after the 21-day period ends.
Storage for five to seven days, including the removal date.
Repetition for up to 13 product-use cycles.
Initial insertion at approximately the same time of day in each cycle.

Claim 1 is narrow because it ties the backup-contraception requirement to a removal event during the 21-day first period. A product label that instructs users to reinsert the ring and use condoms for seven days after cumulative removal exceeding two hours could directly map to this claim.

Claim 6: removal events across the 13-cycle course

Claim 6 covers a broader temporal arrangement. It requires a 13-cycle method and separately requires:

Removal for more than two cumulative hours during at least one 21-day period;
Reinsertion after removal; and
Seven days of a non-estrogen secondary contraceptive after reinsertion.

Unlike claim 1, claim 6 is framed around the occurrence of the removal event in at least one cycle during the 13-cycle regimen. It can potentially read on a label that allows or addresses qualifying removal in any cycle, rather than only the first 21-day period.

Claims 1 and 6 are independent method claims. Claims 2 through 5 depend from claim 1. Claims 7 through 11 depend from claim 6.

How do dependent claims 2 through 5 narrow the patent scope?

Claim	Added limitation	Practical significance
2	Ring is stored at room temperature after removal	Targets ordinary home storage during the ring-free interval
3	More-than-two-hour removal occurs in multiple instances on the same day, consecutive days, nonconsecutive days, or combinations	Captures cumulative removal rather than one continuous event
4	Removal includes intentional removal or expulsion	Covers both user-directed and unintentional removal
5	Backup contraception is a male condom	Narrows the non-estrogen secondary method to condoms

Claim 3 is important because the claims do not require a single uninterrupted removal period. Two or more shorter removal periods can satisfy the cumulative two-hour threshold.

Claim 4 expands the removal event beyond intentional use. Expulsion of the ring can satisfy the claim if the total time outside the vagina exceeds two cumulative hours.

Claim 5 is narrower than claims 1 and 6 because it requires a male condom rather than any non-estrogen contraceptive. A product label recommending condoms would create a direct claim-mapping issue if the other limitations are present.

What formulation and device limitations must be met?

The ring structure is a central claim limitation. The claimed product must have:

A silicone elastomer ring body;
Two internal channels;
A separate core in each channel;
Segesterone acetate distributed through both cores; and
Ethinyl estradiol in one of the cores.

This structure distinguishes the patent from:

A single-reservoir ring;
A matrix ring without discrete cores;
A ring containing only one hormone;
A ring using a different polymer;
A ring containing a different amount of either active ingredient; and
A ring with different release characteristics.

The approximate release-rate language presents a claim-construction issue. The claim does not state a single instantaneous release rate. It refers to average release during a 21-day first period, measured across 13 28-day product-use cycles. The measurement protocol is therefore part of the technical scope. A challenger would likely argue that “approximately” lacks precision or that the claim does not define an acceptable numerical range. The patent owner would likely rely on the specification, clinical development data, and ordinary pharmaceutical usage of “approximately.”

Does Patent 10,632,066 cover Annovera’s composition of matter?

No. The patent does not function as a standalone composition-of-matter patent for segesterone acetate or ethinyl estradiol.

Its protection depends on the combination of:

The specified ring architecture;
The specified drug quantities;
The specified release profile; and
The specified use protocol.

A competitor could avoid literal infringement by changing one or more of those features. Examples include a different reservoir design, different drug loading, a different polymer, a different release profile, or a nonreusable ring. Such changes could still raise infringement issues under the doctrine of equivalents, but the claim text is not directed to the active ingredients alone.

What is the Orange Book status of Patent 10,632,066?

Annovera is an FDA-approved small-molecule drug product listed in the Orange Book under NDA 209306.[2] Patent listing and regulatory exclusivity are separate issues.

Patent 10,632,066 is directed to a method of use involving the approved product and its labeled regimen. A listed method-of-use patent can support a Paragraph IV certification and patent litigation against an ANDA applicant. The practical effect depends on:

Whether the patent is listed against the NDA;
Whether the proposed generic label includes the patented use;
Whether the ANDA applicant uses a section viii statement to carve out the patented method;
Whether the patent owner sues within 45 days after receiving a Paragraph IV notice; and
Whether the FDA imposes a 30-month stay.

The claims are particularly relevant to skinny-label analysis because the regimen is closely tied to how Annovera is used. If FDA-approved labeling contains instructions concerning removal for more than two hours, reinsertion, backup contraception, and reuse over 13 cycles, a carve-out may be difficult without materially changing the contraceptive instructions.

When does Patent 10,632,066 expire?

The patent issued on April 28, 2020.[3] Its term is generally governed by the 20-year period measured from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.

The relevant patent-family priority and continuity data should be read from the issued patent and USPTO Patent Center before calculating a litigation or launch date. The patent should not be treated as expiring on the issue date or on the FDA approval date. Its term is expected to extend into the mid-2030s based on the application filing chronology.

Any commercial launch analysis must distinguish:

Patent expiration;
Patent-term adjustment;
Patent-term extension under 35 U.S.C. § 156;
FDA regulatory exclusivity;
Pediatric exclusivity; and
Settlement-based launch restrictions.

The FDA approval date does not itself establish the patent expiration date.

What FDA regulatory exclusivity applies to Annovera?

Annovera received FDA approval in 2018 as a new contraceptive vaginal system containing segesterone acetate and ethinyl estradiol.[1] Segesterone acetate had not previously been approved as an active ingredient in the United States. FDA regulatory exclusivity is therefore distinct from the patent estate and can affect ANDA timing even if a patent challenge succeeds.

For small-molecule products, the relevant statutory categories include:

Exclusivity type	General effect
New chemical entity exclusivity	Limits submission of a section 505(b)(2) application or ANDA for five years, subject to the Paragraph IV exception
Three-year clinical-investigation exclusivity	Can block approval of certain applications relying on new clinical investigations
Orphan exclusivity	Applies only if the product has an orphan designation and approval for the protected indication
Pediatric exclusivity	Can add six months to qualifying patent and exclusivity periods

The core competitive question is whether an ANDA applicant can rely on the listed drug’s safety and efficacy data while carving out the patented method. For a drug-device product with detailed user instructions, FDA labeling restrictions may be as important as the patent claims.

How strong is the patent estate around Annovera?

The estate is strongest where the challenger’s product reproduces the complete Annovera system and labeling. It is weaker against materially different delivery systems or labels that omit the patented regimen.

Strengths

Exact drug loads correspond to the commercial product.
The ring architecture is technically specific.
The regimen covers up to 13 cycles, the commercial product’s principal convenience advantage.
Cumulative removal language captures repeated short removals.
Expulsion is expressly included.
Backup contraception instructions create a direct connection between the claims and the product label.

Vulnerabilities

The claims are method claims rather than broad composition claims.
“Approximately” may create a numerical-boundary dispute.
“At approximately the same time of day” may be challenged as indefinite or difficult to prove.
“More than two cumulative hours” requires fact-specific evidence concerning actual use.
The patent may be vulnerable to anticipation or obviousness arguments based on earlier vaginal-ring regimens, contraceptive instructions, and clinical protocols.
A generic applicant may attempt a label carve-out or design-around.

The strongest invalidity theories would likely focus on whether prior art disclosed the same reusable ring, the same formulation, and the same cycle-specific instructions in combination. The strongest infringement theory would focus on the approved label rather than individual patient conduct.

What patent litigation and Paragraph IV risks exist?

A generic applicant seeking to market an equivalent segesterone acetate/ethinyl estradiol ring would likely evaluate the patent under three pathways:

Paragraph IV certification. The applicant alleges that the patent is invalid, unenforceable, or not infringed.
Section viii statement. The applicant removes the patented method from its proposed labeling.
Delayed filing or settlement. The applicant accepts a later launch date or waits for patent expiration.

If the NDA holder files suit within 45 days of a Paragraph IV notice, FDA approval may be stayed for up to 30 months under the Hatch-Waxman framework, subject to court rulings and statutory exceptions.[4]

The principal litigation questions would be:

Whether the proposed product has the same two-core silicone ring structure;
Whether the proposed formulation contains the claimed quantities;
Whether its measured release rates fall within the construction of “approximately”;
Whether the proposed label instructs use for 13 cycles;
Whether the label addresses more-than-two-hour removal;
Whether backup contraception is required after reinsertion; and
Whether the applicant can omit enough instructions to avoid induced infringement without making the product unsafe or non-approvable.

No biosimilar pathway applies. Annovera is a small-molecule drug-device product, so competitive entry would proceed through an ANDA or, depending on the product and reliance strategy, a 505(b)(2) application rather than a biosimilar application under the Public Health Service Act.

Which companies are relevant to the Annovera competitive landscape?

The principal rights-holder structure has involved the Population Council and TherapeuticsMD. The Population Council developed the technology and licensed commercial rights for Annovera; TherapeuticsMD commercialized the product in the United States.[5]

The competitive landscape includes:

Annovera as the reusable segesterone acetate/ethinyl estradiol ring;
NuvaRing and its generic equivalents, which use etonogestrel and ethinyl estradiol and are not direct formulation equivalents;
Other monthly or extended-use hormonal vaginal systems;
Potential ANDA applicants seeking to reproduce Annovera’s active ingredients and delivery system; and
Contraceptive ring developers using different progestins, polymers, or release architectures.

NuvaRing generics do not automatically threaten the claims of Patent 10,632,066 because they use a different progestin and different ring technology. Their commercial significance is competitive rather than necessarily infringing.

What generic launch scenarios are most plausible?

Scenario	Patent impact	Commercial result
Same ring, same formulation, same label	High infringement exposure	Paragraph IV litigation likely
Same ring and formulation with a narrow label carve-out	Depends on FDA acceptance and claim scope	Possible delayed or restricted entry
Different reservoir architecture	Lower literal infringement risk	Development and equivalence burden increases
Different hormone loads or release profile	Potential design-around	May require new clinical and regulatory work
Nonreusable ring	Likely outside the principal claims	Competes on a different use model
505(b)(2) product with modified regimen	Patent and regulatory review required	Could avoid some claims but face clinical bridging requirements

A generic launch before patent expiration would require either a successful validity or noninfringement decision, a settlement permitting entry, a label carve-out accepted by FDA, or a product design that avoids the claimed limitations.

What geographic coverage does the patent provide?

Patent 10,632,066 provides rights only in the United States. It does not directly block commercialization in Canada, Europe, Japan, or other jurisdictions.

The international landscape must be assessed separately through:

PCT applications;
National-phase filings;
Country-specific granted patents;
Supplementary protection certificates in Europe;
Local regulatory exclusivity;
Local patent-linkage rules; and
National litigation or settlement agreements.

A U.S. patent can support U.S. importation and sale claims, but it does not establish worldwide exclusivity for segesterone acetate rings.

Key Takeaways

Patent 10,632,066 is a narrow but commercially targeted method-of-use patent for the Annovera reusable vaginal contraceptive system.
Claims 1 and 6 require the specific 103 mg segesterone acetate/17.4 mg ethinyl estradiol two-core silicone ring.
The claims also require a 21-day insertion period, a five- to seven-day storage interval, and reuse for up to 13 28-day cycles.
More than two cumulative hours outside the vagina triggers the reinsertion and seven-day non-estrogen backup requirements in the claimed methods.
The patent does not broadly cover segesterone acetate, ethinyl estradiol, or all contraceptive vaginal rings.
Generic exposure is highest where the proposed product and label replicate Annovera’s formulation, release profile, removal instructions, and 13-cycle regimen.
Biosimilar competition is irrelevant because Annovera is a small-molecule drug-device product.
Patent expiration must be calculated from the patent-family filing data, with patent-term adjustment, extension, and regulatory exclusivity reviewed separately.
The most credible generic strategies are a Paragraph IV challenge, a section viii label carve-out, or a technical design-around.

FAQs

Can a generic avoid Patent 10,632,066 by changing the ring color or shape?

Probably not if the same claimed two-channel silicone structure, drug loads, release profile, and use instructions remain. Cosmetic changes do not remove the core limitations.

Does a patient’s actual removal behavior determine infringement?

For method claims, actual performance can be relevant, but the central commercial issue is often whether the generic label instructs or encourages the claimed conduct. Induced-infringement analysis can therefore matter even when individual patient behavior varies.

Does claim 5 require condom use in every cycle?

Claim 5 depends on claim 1 and narrows the backup method to a male condom. It does not independently replace the other claim 1 requirements.

Can a 13-cycle regimen be omitted from a generic label?

Omitting the 13-cycle instruction may reduce exposure to claims 1 and 6, but the label must remain consistent with FDA requirements and the reference product’s approved use. A partial carve-out can create both regulatory and patent-law issues.

Are international Annovera patents automatically coextensive with U.S. Patent 10,632,066?

No. Foreign family members can have different claims, prosecution histories, expiration dates, and enforceability outcomes. U.S. claim scope cannot be imported into another jurisdiction.

References

U.S. Food and Drug Administration. (2018). FDA approves new vaginal ring for one year of birth control.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
United States Patent and Trademark Office. (2020). U.S. Patent No. 10,632,066, Methods of using a vaginal system.
U.S. Food and Drug Administration. (2023). Hatch-Waxman amendments and abbreviated new drug applications.
Population Council. (2018). Annovera segesterone acetate and ethinyl estradiol vaginal system product and development information.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION	⤷ Start Trial
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Details for Patent: 10,632,066

Which drugs does patent 10,632,066 protect, and when does it expire?

Summary for Patent: 10,632,066