US Patent 10,765,628: Scope, Claims, Expiration and Annovera Patent Landscape

US Patent 10,765,628 protects specific methods for using the Annovera vaginal contraceptive system, rather than the ring composition alone. Its core coverage combines the ring's two-core silicone structure and segesterone acetate/ethinyl estradiol loading with a 21-day in-vagina period, a five- to seven-day removal interval, management of removals exceeding two cumulative hours, and seven days of estrogen-free backup contraception. The patent is associated with the Population Council's Annovera technology and has an estimated patent-term endpoint in March 2037, subject to the USPTO's recorded term adjustment and terminal-disclaimer data.[1]

What product does US Patent 10,765,628 protect?

The claimed product is the reusable Annovera vaginal system, a flexible silicone elastomer ring that delivers:

Component	Claimed or labeled amount
Segesterone acetate	103 mg
Ethinyl estradiol	17.4 mg
Average segesterone acetate release	Approximately 0.15 mg/day
Average ethinyl estradiol release	Approximately 0.013 mg/day
Use period	21 days in the vagina
Removal interval	Five to seven days
Intended use	Up to 13 28-day cycles
Ring diameter in claim 1	Approximately 56 mm
Ring cross-sectional diameter in claim 1	Approximately 8.4 mm

The patent does not broadly claim every vaginal contraceptive ring containing segesterone acetate and ethinyl estradiol. It claims methods that use a ring with defined structural, quantitative, dosing, and user-instruction limitations.

The FDA-approved Annovera label describes the same general use pattern: insertion for 21 days, removal for seven days, and reuse for up to 13 cycles. The product is indicated for females of reproductive potential and is supplied for vaginal use under NDA 209306.[2]

What are the independent claims in US Patent 10,765,628?

The patent has three independent method claims: claims 1, 6, and 12. They are directed to overlapping but materially different use protocols.

Claim 1: Initial-cycle timing and removal-management method

Claim 1 requires all of the following:

Initial insertion on menstrual-cycle day 2, 3, 4, or 5.
A silicone elastomer ring with:
- approximately 56 mm overall diameter;
- approximately 8.4 mm cross-sectional diameter;
- two internal channels;
- two drug-containing cores.
A total of 103 mg segesterone acetate distributed between the two cores.
A total of 17.4 mg ethinyl estradiol in one of the cores.
Average release rates of approximately 0.15 mg/day and 0.013 mg/day, respectively.
A 21-day first period.
Removal from the vagina for more than two cumulative hours during that period.
Reinsertion after removal.
Seven days of secondary contraception without estrogen.
Removal on the day after the 21-day period.
Repetition for no more than 13 product-use cycles.

Claim 1 is the narrowest independent claim because it expressly requires the ring dimensions, initial insertion timing, defined release rates, 13-cycle framework, and a removal event exceeding two cumulative hours.

Claim 6: Thirteen-cycle use and storage method

Claim 6 omits the specific 56 mm and 8.4 mm dimensions but retains the principal ring architecture and drug quantities. It requires:

insertion on menstrual-cycle day 2, 3, 4, or 5;
a 21-day first period;
removal on the following day;
storage for a second period of five to seven days, including the removal date;
up to 13 product-use cycles;
insertion at approximately the same time of day in successive cycles;
removal for more than two cumulative hours;
reinsertion;
seven days of estrogen-free secondary contraception.

Claim 6 therefore shifts the center of gravity from physical ring dimensions to the operational regimen and storage interval.

Claim 12: Removal and backup-contraception method

Claim 12 is the broadest independent claim in functional terms. It requires:

insertion of the specified two-channel, two-core ring;
103 mg segesterone acetate;
17.4 mg ethinyl estradiol;
the specified average release rates;
removal for more than two cumulative hours during a 21-day period;
reinsertion;
seven days of estrogen-free backup contraception.

Unlike claims 1 and 6, claim 12 does not expressly require insertion on cycle day 2 through 5, a 13-cycle course, or the five- to seven-day storage period.

How do dependent claims 2 through 17 narrow the patent?

The dependent claims add operational details that are closely aligned with the Annovera prescribing instructions.

Claims	Added limitation
2	Storage at room temperature while the ring is out of the vagina
3	More-than-two-hour removal achieved through multiple events on the same or different days
4	Removal may be intentional or caused by expulsion
5	Secondary contraception may be a male condom
7	Intentional, unintentional, or combined removals
8	Unintentional removal includes expulsion
9	At least two removal instances
10	Removal instances may occur on the same or different days
11	Different days may be consecutive or nonconsecutive
13	Intentional, unintentional, or combined removals
14	Unintentional removal includes expulsion
15	At least two removal instances
16	Same-day or different-day removal events
17	Consecutive or nonconsecutive different days

The dependent claims provide fallback positions if a court narrows an independent claim. Their commercial relevance is limited if the FDA label already instructs users to manage ring expulsion or prolonged removal in substantially the same way. Their litigation value is greater where a generic label reproduces the instructions expressly or where the proposed product is marketed for the same use.

What is the legal scope of the patent?

US 10,765,628 is a method-of-use patent with embedded product limitations. A potential infringement theory would generally require proof that an accused product is used according to the claimed regimen, not merely that it contains segesterone acetate and ethinyl estradiol.

The patent's scope can be divided into four elements:

1. Device identity

The ring must have the claimed two-channel and two-core arrangement. Claim 1 also requires approximate external dimensions. A ring with different dimensions or a materially different drug-core architecture may avoid some claim limitations, although claims 6 and 12 do not contain the full dimensional limitation.

2. Drug loading and release

The method requires 103 mg segesterone acetate and 17.4 mg ethinyl estradiol, together with approximate average release rates. These limitations create a product-specific boundary. A generic product with materially different loading, release kinetics, or distribution may raise non-infringement arguments, but bioequivalence requirements could make design-around difficult.

3. Use schedule

Claims 1 and 6 require the 21-day use period and repeated 28-day cycles. Claim 6 also requires storage during the five- to seven-day interval and insertion at approximately the same time of day in later cycles.

4. Removal-event management

The most distinctive limitation is removal for more than two cumulative hours followed by reinsertion and seven days of estrogen-free backup contraception. The claims cover both intentional removal and expulsion, including multiple removal events.

Because the claims are method claims, liability may depend on the product label, instructions for use, promotional communications, prescriber conduct, and the extent to which the manufacturer encourages the claimed regimen. Direct infringement by patients is a separate question from inducement or contributory infringement by a manufacturer.

When does US Patent 10,765,628 expire?

The patent is associated with a March 2037 patent-term endpoint based on the relevant family filing history. The precise expiration date should be taken from the USPTO patent record because patent-term adjustment can change the nominal 20-year term.[1]

Event	Date or period
Patent type	US utility patent
Patent number	10,765,628
Patent title	Methods of using a vaginal ring
FDA product associated with technology	Annovera
FDA approval	August 10, 2018
Estimated patent-term endpoint	March 2037
FDA new chemical entity exclusivity	Approximately through August 10, 2023
Patent protection remaining after FDA exclusivity	Approximately 13 years on the estimated endpoint

FDA exclusivity and patent protection are separate. Annovera's five-year new chemical entity exclusivity did not replace or shorten the patent term. Once FDA exclusivity ended, an ANDA applicant could potentially file a Paragraph IV certification against listed patents, subject to the Orange Book listing and patent-litigation framework.

What is the Orange Book status of Annovera?

Annovera is approved under FDA NDA 209306. The Orange Book is the controlling source for patents submitted by the NDA holder and listed against the product. Annovera's patent estate has included patents directed to the ring, drug delivery, and methods of use.[2][3]

For US 10,765,628, the commercially relevant question is whether it is listed against the approved drug and whether the listing remains active for the relevant dosage form and method of use. A listed method-of-use patent may be challenged through a Paragraph IV certification or carved out through a section viii statement, depending on the claim language and the approved labeling.

The patent's close alignment with labeled Annovera instructions makes a pure label carve-out more difficult than for a method claim covering an optional or non-approved use. A generic applicant would need to assess whether it can omit the claimed removal-management instruction while still obtaining approval for the remaining approved use.

Which companies are challenging the Annovera patent estate?

The public commercial risk centers on potential ANDA applicants seeking approval for a reusable segesterone acetate/ethinyl estradiol ring. The relevant challenger would need to address both listed patents and the regulatory requirements for a complex vaginal delivery system.

The main legal routes are:

Paragraph IV certification that a listed patent is invalid, unenforceable, or not infringed;
section viii certification with an omission of the patented method from labeling;
approval after patent expiration;
licensing or settlement with the patent holder.

A definitive list of active challengers and any 30-month litigation stay must be taken from current FDA Orange Book records and federal district-court filings. The patent claims supplied do not identify a challenger, ANDA number, complaint, settlement, or court judgment. No specific company can be assigned challenger status solely from the claim text.

What patent litigation affects US 10,765,628?

A litigation analysis must distinguish three categories:

Category	Relevance to US 10,765,628
Composition or device litigation	Tests the ring's cores, channels, materials, drug loading, or release profile
Method-of-use litigation	Tests the 21-day regimen, removal instructions, backup contraception, and cycle timing
Regulatory litigation	Tests Orange Book listing, Paragraph IV certification, section viii labeling, or FDA approval timing

For this patent, the most likely dispute points are:

Whether the accused ring has the claimed two-core structure.
Whether the product contains the claimed quantities and average release rates.
Whether the generic label instructs users to reinsert after more than two cumulative hours out of the vagina.
Whether the label requires seven days of non-estrogen backup contraception.
Whether the generic can omit cycle-day timing or the 13-cycle reuse instructions.
Whether the claims are enabled and adequately supported across the claimed release-rate range.
Whether the method claims are anticipated by earlier vaginal-ring clinical protocols or product instructions.

The patent is vulnerable to a divided-infringement defense if the manufacturer does not direct the critical user steps. That defense is weaker when the FDA-approved label expressly instructs the patient to follow every claimed step.

How strong is the patent estate for Annovera?

The estate is stronger as a combined portfolio than as a single patent. US 10,765,628 has meaningful commercial coverage because it ties the physical ring to the labeled use protocol. A competitor may avoid one claim limitation but still face other patents covering the device or formulation.

Strengths

The claims identify a commercial product with unusual structural and dosing characteristics.
The method covers both intentional removal and accidental expulsion.
Multiple dependent claims create fallback positions for cumulative removal events.
The seven-day estrogen-free backup requirement tracks the product's clinical-use instructions.
The claims extend through the expected period of commercial exploitation.

Weaknesses

The independent claims require numerous limitations.
The removal and reinsertion steps may create divided-infringement issues.
Approximate dimensions and average release rates may create measurement disputes.
Prior art involving contraceptive rings, cyclic use, expulsion, and backup contraception may be relevant to validity.
A competitor may attempt to design around the cycle timing, ring dimensions, storage conditions, or label language.

The strongest enforcement position would likely involve a product that is structurally equivalent to Annovera and carries instructions substantially identical to the claimed regimen. The weakest position would involve a ring with different architecture and a label that omits the prolonged-removal protocol.

What manufacturing and intellectual-property barriers exist?

Annovera presents higher entry barriers than a conventional oral contraceptive. A competing manufacturer would need to reproduce or establish:

a silicone elastomer ring with two internal channels;
two drug-containing cores;
stable incorporation of segesterone acetate and ethinyl estradiol;
controlled release over 21 days;
stability during room-temperature storage;
reproducible performance over repeated reuse cycles;
compatibility with FDA requirements for a complex drug-device combination.

The manufacturing process may be protected by related patents, trade secrets, know-how, or regulatory data even where a competitor avoids literal infringement of US 10,765,628. The need to demonstrate consistent release after repeated insertion, removal, storage, and reinsertion increases development risk.

How does US 10,765,628 compare with composition and formulation patents?

Patent category	Primary protection	Design-around potential
Device-structure patent	Ring geometry, channels, cores, elastomer	Moderate, depending on architecture
Formulation or release patent	Drug loading, excipients, diffusion and release rates	Moderate to low if release targets are necessary for equivalence
Method-of-use patent	Insertion, 21-day use, removal, backup contraception	Moderate through labeling or regimen changes
Manufacturing patent	Core fabrication, loading, molding, assembly	Variable; trade-secret overlap may remain
Regulatory exclusivity	FDA approval and exclusivity periods	Ends independently of patent term

US 10,765,628 is not a complete substitute for the broader device and formulation estate. It operates as a use-protocol layer. A successful design-around would need to avoid the claimed method while still meeting FDA requirements and preserving contraceptive efficacy.

What generic launch scenarios exist?

Scenario 1: Paragraph IV challenge

A generic applicant certifies that the patent is invalid, unenforceable, or not infringed. Litigation may delay approval, with the first applicant potentially receiving 180-day generic exclusivity if statutory requirements are met.

Scenario 2: Section viii carve-out

The applicant omits the patented prolonged-removal and backup-contraception instructions from its labeling. This route is difficult if those instructions are necessary for safe and effective use of the approved product.

Scenario 3: Product design-around

The applicant develops a ring with different dimensions, core architecture, drug loading, or release profile. This approach may avoid claim 1 but still face claims 6 or 12 and other patents in the Annovera estate.

Scenario 4: Post-expiration launch

A competitor waits until the relevant patent term ends. This minimizes litigation exposure but gives the innovator a long period of potential market protection.

Scenario 5: License or settlement

A license can establish an authorized entry date and resolve infringement claims. The value depends on the remaining patent term, litigation strength, regulatory exclusivity, and expected contraceptive-market revenue.

What revenue exposure does the patent create?

The patent's economic value is tied to Annovera's ability to maintain pricing and market share against generic or follow-on vaginal systems. The relevant revenue exposure is not limited to sales directly attributable to the use instructions. A successful challenge to this patent could reduce the overall exclusivity value of the product if the remaining device and formulation patents are weak or expired.

The most sensitive commercial variables are:

annual Annovera prescriptions;
refill and reuse persistence across 13 cycles;
net price after rebates and access programs;
payer coverage;
generic substitution rules;
the number of viable ANDA applicants;
the enforceability of the device and formulation patents;
whether a generic can obtain approval without reproducing the patented label.

Because the claims cover the approved 13-cycle regimen, a generic launch could affect the product's full recurring-use model rather than only a single dispensing event.

Key Takeaways

US 10,765,628 is primarily a method-of-use patent for the Annovera vaginal contraceptive system.
Its core limitations are the two-core silicone ring, 103 mg segesterone acetate, 17.4 mg ethinyl estradiol, 21-day use, prolonged removal exceeding two cumulative hours, reinsertion, and seven days of estrogen-free backup contraception.
Claim 1 is narrowest because it adds ring dimensions and initial insertion on menstrual-cycle days 2 through 5.
Claim 6 emphasizes 13-cycle use, storage for five to seven days, and consistent insertion timing.
Claim 12 is the broadest independent method claim but still requires the specified ring composition and release rates.
Dependent claims cover room-temperature storage, intentional removal, expulsion, and multiple removal events.
The estimated patent-term endpoint is in March 2037, subject to the USPTO record.
FDA new chemical entity exclusivity was separate from the patent term and ran approximately through August 2023.
The principal generic risks are Paragraph IV litigation, a section viii label carve-out, or a structural and labeling design-around.
The patent is commercially strongest when asserted with the related Annovera device, formulation, and manufacturing patents.

FAQs

Does US 10,765,628 cover the Annovera ring itself?

No. It covers methods of using a ring with specified structural and drug-delivery characteristics. Separate patents may cover the ring, formulation, release profile, or manufacturing process.

Can a generic avoid US 10,765,628 by changing the ring diameter?

Possibly for claim 1, because claim 1 expressly requires approximately 56 mm overall diameter and approximately 8.4 mm cross-sectional diameter. Claims 6 and 12 do not include both dimensional limitations, so a diameter change alone may not avoid the entire patent family.

Does accidental expulsion fall within the patent claims?

Yes. Claims 4, 7, 8, 13, and 14 expressly cover unintentional removal and expulsion, including combinations of intentional and unintentional removal.

Is a male condom an acceptable backup method under the claimed regimen?

Yes. Claim 5 specifically identifies a male condom as an estrogen-free secondary contraception product.

Does FDA approval automatically establish infringement of US 10,765,628?

No. FDA approval and patent infringement are separate legal determinations. The relevant question is whether the approved product, labeling, instructions, and resulting use satisfy every limitation of an asserted claim.

Sources

United States Patent and Trademark Office. (2020). U.S. Patent No. 10,765,628, Methods of using a vaginal ring.
U.S. Food and Drug Administration. (2018). Annovera prescribing information. TherapeuticsMD, Inc.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2018). FDA approves new vaginal ring for birth control that can be used for one year.
United States Code, 35 U.S.C. §§ 154, 271, and 355.

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	10,765,628	⤷ 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
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,765,628	⤷ 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Summary for Patent: 10,765,628