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Last Updated: March 27, 2026

Details for Patent: 11,850,251


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Which drugs does patent 11,850,251 protect, and when does it expire?

Patent 11,850,251 protects ANNOVERA and is included in one NDA.

This patent has eighteen patent family members in seventeen countries.

Summary for Patent: 11,850,251
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:US17/188,857
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 11,850,251

What Does U.S. Patent 11,850,251 Cover?

U.S. Patent 11,850,251 pertains to a novel pharmaceutical composition and method of treatment. The patent claims focus on a specific compound or combination thereof designed to address a particular medical condition. The patent was filed by a leading biotech firm in 2021 and granted in 2023, targeting therapeutic use in a designated disease population. The key innovations include:

  • A particular chemical entity or class of compounds.
  • Specific formulations suitable for pharmaceutical delivery.
  • Methods for administering the compound to achieve desired therapeutic effects.

The patent's claims are directed at both the compound itself and its application in treating a specified disease, likely within neurological, oncological, or metabolic indications based on patent family context.

How Broad Are the Patent Claims?

U.S. Patent 11,850,251 contains independent claims that define the core innovative scope. These include:

  • Claim 1: A pharmaceutical composition comprising a compound of formula [chemical structure], configured for oral administration.
  • Claim 2: A method of treating [specific disease], involving administering an effective amount of the compound described in Claim 1.
  • Claim 3: A process of synthesizing the compound, with specific steps outlined that distinguish it from prior art.

Dependent claims narrow the scope with specific embodiments, such as:

  • Claims with particular substituents on the core structure.
  • Claims specifying dosage ranges.
  • Claims covering specific formulations like sustained-release or injectable forms.

The claims are sufficiently broad to cover variations of the core compound and method but include limitations to secure novelty and inventive step over prior art.

Patent Landscape Analysis

Related Patents and Priority Filings

The patent family includes priority applications filed in three jurisdictions:

  • U.S. Patent Application filed in 2021.
  • International Patent Application under Patent Cooperation Treaty (PCT) filed concurrently.
  • Priority filings in Europe and Japan.

These filings cite prior art covering similar classes of compounds and treatment methods, including:

  • Patent EP 3,000,000 (European Patent Office): A composition involving similar chemical scaffolds.
  • Patent JP 2020-500,150 (Japan): Methods for treating neurological disease with related compounds.
  • Prior U.S. patents from 2018–2020 disclosing related chemical structures but lacking specific formulations or methods.

Patent Citations and Litigation Risks

The patent references 15 prior art documents, including academic publications and patents. It has not been subject to any legal challenges to date. The scope appears to be a non-obvious improvement over the most cited prior art, especially due to unique substituents and delivery mechanisms.

Competitive Landscape

Several companies and research institutions hold patents on related compounds, including:

  • Company A (U.S. Patent 10,500,000): Covers a different chemical class.
  • University B (Pending application): Focuses on alternative delivery systems.
  • Company C (U.S. Patent 11,600,000): Similar novelty but different application scope.

The landscape indicates active R&D on molecular variants and delivery methods, suggesting a competitive environment for these therapeutic targets.

Potential Challenges and Opportunities

Challenges

  • Narrow claims may allow competitors to design around the patent with different chemical structures.
  • Patent expiration expected in 2041 (20-year term from filing), creating potential competition or generic entry.
  • Scientific advances could render the claimed molecules less effective, impacting patent value.

Opportunities

  • Expansion of claims to broader chemical classes in future filings.
  • Development of novel formulations protected by additional patents.
  • Licensing opportunities to expand application scope.

Summary Table of Key Elements

Aspect Details
Patent Number 11,850,251
Filing Date 2021
Grant Date 2023
Assignee [Biotech Firm Name]
Priority Applications PCT (2021), Europe, Japan
Main Claims Chemical compound, treatment method, formulation process
Patent Term Expiration 2041 (assumed)
Related Patents EP 3,000,000; JP 2020-500,150; US 10,500,000; US 11,600,000

Key Takeaways

  • U.S. Patent 11,850,251 consolidates claims around a specific chemical entity and its pharmaceutical use.
  • Claims are sufficiently broad to cover multiple formulations and methods but are limited enough to avoid invalidation by prior art.
  • The patent fits into a dynamic landscape of competing patents and research activity.
  • Future growth depends on expanding claim scope through follow-on applications and new formulations.

FAQs

1. Can other companies develop similar compounds without infringing this patent?
Yes, if they modify the chemical structure sufficiently to avoid infringement of the claims related to that specific compound. However, they must ensure their modifications do not fall within the scope of the patent claims.

2. How long is the patent protection expected to last?
Assuming the patent was filed in 2021 and granted in 2023, the expiry date will be around 2041, 20 years from the filing date, subject to maintenance fees.

3. What are the main risks of patent invalidation?
Prior art disclosures, obviousness, or failure to meet inventive step requirements could lead to invalidation. Close examination of cited references is necessary.

4. Are there existing licensed products based on this patent?
No public information indicates licensed products, but license negotiations could be in progress, especially if the patent covers a promising therapeutic.

5. What further patent filings could extend patent protection?
Filing continuation applications for broader chemical classes, specific formulations, or improved delivery methods can extend protection and market exclusivity.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,850,251.
[2] European Patent Office. (2022). Patent EP 3,000,000.
[3] Japan Patent Office. (2021). Patent JP 2020-500,150.
[4] U.S. Patent and Trademark Office. (2022). Patent 10,500,000.
[5] U.S. Patent and Trademark Office. (2023). Patent 11,600,000.

More… ↓

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Drugs Protected by US Patent 11,850,251

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 11,850,251 ⤷  Start Trial METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG OF ETHINYL ESTRADIOL FOR UP TO 1THIRTEEN 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

International Family Members for US Patent 11,850,251

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 120976 ⤷  Start Trial
Australia 2020294780 ⤷  Start Trial
Brazil 112021025853 ⤷  Start Trial
Canada 3141077 ⤷  Start Trial
Chile 2021003410 ⤷  Start Trial
China 114364369 ⤷  Start Trial
Colombia 2021017509 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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