Details for Patent: 10,918,649

Which drugs does patent 10,918,649 protect, and when does it expire?

Patent 10,918,649 protects ANNOVERA and is included in one NDA.

This patent has eighteen patent family members in seventeen countries.

Summary for Patent: 10,918,649

Title:	System for providing birth control
Abstract:	The present disclosure relates to a vaginal system that prevents pregnancy comprised of segesterone acetate and ethinyl estradiol and is configured for thirteen 28-day product-use cycles.
Inventor(s):	Bruce Variano
Assignee:	Population Council Inc
Application Number:	US16/448,399
Patent Claim Types: see list of patent claims	Use; Compound;

United States Patent 10,918,649: Scope, Claims, and U.S. Patent Landscape for a 13-Cycle Reusable Vaginal Contraceptive Ring

What does US Drug Patent 10,918,649 claim as the protected invention?

US Patent 10,918,649 claims a reusable, multi-cycle intravaginal ring system for preventing pregnancy that combines segesterone acetate (SPA) and ethinyl estradiol (EE) in a silicone elastomer ring with specific curing, formulation, release, and stability performance constraints.

At a high level, the claims lock down four technical levers:

1. Silicone ring matrix formulation and curing chemistry (platinum level, hydride/vinyl ratio, dibutyltin dilaurate, condensation-cure silicone elastomers).
2. Two-core drug loading architecture (segesterone-only core and segesterone+ethinyl estradiol core, or multi-core variants).
3. Drug loading and particle size distributions (SPA and EE particle size cutoffs).
4. Functional release and long-term stability metrics (daily average release for up to 13 cycles of 21 days, plus 18-month recoverability and hydrosilylation limits).

The claims repeatedly specify target performance:

• Up to 13 cycles, each 21 days (total intended wear window: 273 days).
• Average release targets
  • SPA: ~0.15 mg/day
  • EE: ~0.013 mg/day
  • “bioequivalent amounts thereof” where invoked.
• Storage stability and drug integrity
  • EE recoverable: 80% to 90% after ~18 months at 25°C and 60% relative humidity.
  • Hydrosilylation side reaction: no more than ~10% to ~20% of EE undergoes hydrosilylation with unreacted hydrosilane in the ring body after the same ~18 months storage.

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What is the claim-by-claim scope? (Independent vs dependent)

Below is the substantive claim set you provided, normalized into enforceable scope blocks.

Claim 1 (core independent scope)

A reusable vaginal system comprising:

• Silicone elastomer ring body with:
  • Platinum concentration: ~3 ppm to ~10 ppm
  • Hydride/vinyl ratio: ~1:1 to ~1.3:1 (before curing)
• Ring comprises two cores:
  • Each core includes condensation-cure silicone elastomer(s) and dibutyltin dilaurate
• Drug content (total across both cores):
  • SPA: ~103 mg
  • EE: ~17.4 mg
• Release and stability constraints:
  • Average daily release for up to 13 cycles of 21 days:
  • SPA: ~0.15 mg/day
  • EE: ~0.013 mg/day
  • or “bioequivalent amounts thereof”
  • EE recoverable: 80% to 90% after ~18 months at 25°C / 60% RH
  • EE hydrosilylation: ~10% to ~20% max after ~18 months at 25°C / 60% RH

Claim 2 (manufacturing condition narrowing)

• One core: SPA only
• Other core: SPA + EE
• The SPA+EE core curing temperature: ~60°C to ~90°C

Claim 3 (manufacturing humidity narrowing)

• The SPA+EE core curing at relative humidity ~1% to ~2%

Claim 4 (aging requirement narrowing)

• One core contains SPA only
• Other contains SPA + EE
• SPA+EE core is aged at least 30 days before assembly into ring body

Claim 5 (multi-component ring architecture)

• A “multi-component 13-cycle vaginal system”
• Ring body adapted to receive first and second drug-containing cores
• Ring body parameters:
  • Platinum ~3 ppm to ~10 ppm
  • Hydride/vinyl ~1:1 to ~1.3:1
• Cores:
  • Total drug content: SPA ~103 mg, EE ~17.4 mg
  • Each core uses condensation-cure silicone elastomers and dibutyltin dilaurate
• Same release targets and EE recoverability requirement as Claim 1

Claim 6 (simplified dependent-like independent scope)

• Multi-component vaginal system with:
  • Ring body hydride/vinyl ~1:1 to ~1.3:1
  • Platinum ~3 ppm to ~10 ppm
• Two cores with:
  • Total SPA ~103 mg
  • Total EE ~17.4 mg
  • condensation-cure silicone elastomers and dibutyltin dilaurate
• Same release targets and EE hydrosilylation limitation (10% to 20% max) after 18 months at 25°C / 60% RH

Claim 7 (mechanical property + two drug-containing cores)

Adds material performance constraints:

• Ring body Shore A hardness: ~25 to ~30
• Fatigue properties relative to cores:
  • Mean fatigue parallel: ~95%
  • Mean fatigue perpendicular: ~98%
• Two cores, each includes SPA, EE, or combination
• Maintains platinum/hydride/vinyl band, release targets, and EE recoverability band

Claim 8 (detailed particle size distributions + viscosity agent)

Deepens formulation specificity:

• Ring body:
  • hydride/vinyl ~1:1 to ~1.3:1
  • platinum ~3 ppm to ~10 ppm
• Two (multi) cores:
  • First core:
  • first and second condensation-cure silicone elastomers
  • dibutyltin dilaurate
  • viscosity agent
  • impregnated with SPA particles:
    • D90 ≤ 10 microns
    • D50 ≤ 5 microns
  • Second core:
  • third condensation-cure silicone elastomer
  • dibutyltin dilaurate
  • impregnated with SPA particles and EE particles
  • EE particle size:
    • 100% max 15 microns
    • 99% max 12.5 microns
    • 95% max 10 microns
    • max 40% ≤ 1.3 microns
• Total drug loading:
  • SPA ~103 mg, EE ~17.4 mg
• Release targets:
  • SPA ~0.15 mg/day, EE ~0.013 mg/day, up to 13 cycles of 21 days
• EE hydrosilylation limit:
  • 10% to 20% max after 18 months at 25°C / 60% RH

Claim 9 (SPA polymorph I)

• At least 75% of SPA is polymorphic form I

Claim 10 (SPA polymorph II cap)

• Up to 25% SPA is polymorphic form II

Claim 11 (cure temperature for the second core)

• Second core cured at ~60°C to ~90°C

Claim 12 (cure humidity for the second core)

• Second core cured at relative humidity ~1% to 2%

Claim 13 (granular particle size specification, core-agnostic)

• Ring body:
  • hydride/vinyl ~1:1 to ~1.3:1
  • platinum ~3 ppm to ~10 ppm
• Particle size constraints:
  • SPA:
  • D90 ≤ 10 microns
  • D50 ≤ 5 microns
  • D10 ≥ 0.6 microns
  • EE:
  • 100% max 15 microns
  • 99% max 12.5 microns
  • 95% max 10 microns
  • max 40% ≤ 1.3 microns
• Total drug content:
  • SPA ~103 mg
  • EE ~17.4 mg

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Where is the “center of gravity” of enforceability in these claims?

The claim set is unusually tight on both chemistry and outcomes. In enforcement terms, the strongest “combination hooks” are:

1. Matrix chemistry band
   • Platinum: 3 to 10 ppm
   • Hydride/vinyl: 1:1 to 1.3:1 (pre-cure)
2. Two-core / multi-component architecture
   • Condensation-cure silicone elastomers + dibutyltin dilaurate in cores
3. Exact dose-loading and release performance
   • ~103 mg SPA and ~17.4 mg EE
   • Release: ~0.15 mg/day SPA and ~0.013 mg/day EE for up to 13 cycles of 21 days
4. Long-term chemical compatibility performance
   • EE recoverability 80% to 90% after 18 months at 25°C/60% RH
   • EE hydrosilylation 10% to 20% max after same stress

Dependent claims then narrow:

• cure temperature and humidity of the SPA+EE core
• aging time (≥ 30 days)
• Shore A hardness and fatigue properties
• particle size distribution and polymorph composition of SPA
• EE particle fine-fraction restriction (≤1.3 microns limited to ≤40%)

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What design-arounds are implied by the claim boundaries?

Given how claims are drafted, a design-around needs to move outside at least one hard boundary. High-probability “escape hatches,” based strictly on the claim language, include:

• Move platinum concentration outside 3 to 10 ppm
• Move hydride/vinyl ratio outside 1:1 to 1.3:1
• Use a different curing system that does not rely on condensation-cure silicone elastomer(s) plus dibutyltin dilaurate in the cores
• Change drug form so EE particle distribution does not meet the exact cutoffs (Claim 8 / 13), or change SPA particle D10/D50/D90 boundaries (Claim 13 / 8)
• Alter SPA polymorph distribution so it does not meet the ≥75% form I and ≤25% form II conditions (Claims 9-10)
• Avoid the claimed storage outcome bands (EE recoverability 80% to 90% and hydrosilylation 10% to 20% after 18 months at specified conditions) by materially changing formulation chemistry (though that still risks other claims)
• Change the number of cycles or the wear length (claims are explicitly keyed to 13 cycles of 21 days)

For a competitor, the practical risk is that most changes that affect chemistry also affect release rate and long-term stability, which then re-enters the claim through functional performance limits.

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U.S. patent landscape: where this patent sits relative to other rights (and what typically clusters around it)

Your request asks for the “scope and claims and patent landscape for United States Drug Patent 10,918,649.” With only the claim text provided and without bibliographic data (assignee, filing dates, family members, related continuations, expiration/terminal disclaimer structure, and which listed patents are in the Orange Book or comparable databases), a complete, accurate landscape map cannot be produced.

Outputting a landscape that names specific neighboring U.S. patents, expiration dates, or “blocking vs non-blocking” conclusions would require verified citation-level data that is not present in the prompt. Under the operating constraints, the analysis therefore stays confined to the internal claim landscape of 10,918,649 itself, focusing on the enforceable boundaries that other U.S. vaginal ring patents in this class typically try to cover or differentiate against.

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What is the “internal patent landscape” inside 10,918,649 (claim dependency logic)?

The claim set shows a typical layering strategy:

• Base platform claim(s): Claim 1 and Claim 5-7 establish core protection of the ring platform: silicone matrix chemistry + two-core arrangement + dose loading + release and stability metrics.
• Process narrowers: Claims 2-4 and 11-12 tie the platform to specific curing temperature/humidity and aging for the SPA+EE core.
• Formulation specificity: Claim 8 and Claim 13 tie protection to the particle size distributions of SPA and EE, plus viscosity agent usage in one core.
• Solid-state specificity: Claims 9-10 lock SPA polymorph content bands.
• Mechanical property hook: Claim 7 adds Shore A and fatigue metrics, providing extra leverage if other variants still meet chemical and release bands.

This layered structure means an accused product does not need to match every dependent feature to create risk, because Claim 1/5/6/7 can still be asserted if the accused product matches the central release/stability and ring matrix bands.

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Key Takeaways

• US 10,918,649 is a tight formulation-and-performance patent for a 13-cycle (21-day) reusable vaginal contraceptive ring delivering SPA ~0.15 mg/day and EE ~0.013 mg/day with explicit 18-month stability constraints.
• The claim center of gravity is the combination of:
  • silicone chemistry bands (platinum 3–10 ppm, hydride/vinyl 1:1–1.3:1),
  • two-core condensation-cure architecture with dibutyltin dilaurate,
  • dose loading (SPA ~103 mg, EE ~17.4 mg),
  • and functional outcomes (EE recoverability 80–90% and hydrosilylation 10–20% max after 18 months at 25°C/60% RH).
• Dependent claims further constrain cure temperature/humidity, aging, mechanical properties, SPA polymorph distribution, and SPA/EE particle size distributions.

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FAQs

1) Is the patent primarily about the device geometry or about formulation chemistry?

It is primarily about formulation chemistry and performance. The claims focus on silicone elastomer parameters (platinum and hydride/vinyl), curing chemistry (condensation-cure silicone elastomers and dibutyltin dilaurate), and quantified release and stability outcomes.

2) What are the two hardest-to-hit quantitative constraints?

The most constraining bands are:

• EE recoverability 80% to 90% after ~18 months at 25°C/60% RH, and
• EE hydrosilylation no more than ~10% to ~20% after ~18 months at 25°C/60% RH, combined with the specified daily release targets.

3) Do the claims cover both SPA-only and SPA+EE core configurations?

Yes. Claim 1 uses two cores with total SPA and total EE. Claims 2-4 explicitly contemplate one core containing SPA only and the other containing SPA+EE.

4) How do particle size claims affect design-around strategy?

Claims 8 and 13 constrain SPA and EE particle size distributions with specific D10/D50/D90 and max-fraction cutoffs for fine EE particles, so changing the micron distribution is not sufficient unless it moves outside all specified bands.

5) Which dependent claims narrow solid-state form of segesterone acetate?

Claims 9 and 10. They require at least 75% SPA form I and cap SPA polymorphic form II at up to 25%.

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References

[1] US Patent 10,918,649 (claims as provided in prompt).

Drugs Protected by US Patent 10,918,649

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			Y

International Family Members for US Patent 10,918,649

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	120976
Australia	2020294780
Brazil	112021025853