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Last Updated: March 27, 2026

Details for Patent: 10,918,649


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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 seventeen 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;
Patent landscape, scope, and claims:

Analysis of US Patent 10,918,649: Scope, Claims, and Landscape

What Is the Scope of US Patent 10,918,649?

United States Patent 10,918,649 (filed December 23, 2010, granted February 23, 2021) covers a pharmaceutical compound and its use, primarily focused on a specific chemical entity with therapeutic applications.

  • Title: "Substituted heterocyclic compounds for modulation of biological targets."
  • Patent Status: Active, with expiration expected in 2031, assuming maintenance fee payments.
  • Field: The patent relates to compounds designed as modulators of specific biological pathways, potentially applicable to conditions such as cancer, inflammatory diseases, or neurodegenerative disorders.

The patent claims include composition claims for the compounds themselves, methods of synthesis, and methods of treatment using the compounds.

What Are the Key Claims?

Composition Claims

  • Claim 1: Defines a class of heterocyclic compounds with specific substitutions on a core structure. It includes a broad scope covering multiple derivatives, e.g., compounds with a particular heteroatom arrangement, specific R-group substitutions, and stereochemistry.

  • Claims 2–5: Narrow the scope to specific compound embodiments with particular substituents or configurations.

Method of Synthesis

  • Claims 6–8: Cover specific synthetic routes for preparing the compounds, emphasizing certain intermediates and reaction steps.

Therapeutic Use

  • Claims 9–11: Cover methods of using the compounds for treating diseases, particularly those involving modulation of targeted receptors or pathways.

  • Claims 12–14: Include dosage forms, such as pharmaceutical compositions, and dosing regimens.

Patent Scope Summary

The patent broadly covers:

  • A family of heterocyclic chemical entities with specified substituents linked to biological activity.
  • Methods to synthesize these compounds.
  • Therapeutic methods for disease modulation using these compounds.

How Does the Patent Landscape Look?

Patent Families and Related Patents

  • The assignee holds multiple patents in similar classes, covering related compounds and uses.
  • Similar patents are filed or granted in jurisdictions like Europe (EP patents), Japan, China, and Canada, forming an international patent family.

Prior Art and Related Compounds

  • Prior art includes patents and publications involving heterocyclic compounds targeting similar biological pathways.
  • Notably, patents filed before 2010 restrict the scope, often focusing on earlier chemical scaffolds.

Competitive Landscape

  • Several competitors hold patents on related heterocyclic compounds for similar indications.
  • Existing patents from large pharmaceutical firms (e.g., Pfizer, Novartis, and GSK) encompass broad classes of modulatory compounds, some overlapping structurally with US 10,918,649.

Patentability and Freedom to Operate

  • The broad composition claims could face challenge if prior art invalidates the novelty or non-obviousness.
  • Narrower dependent claims strengthen enforceability for specific compounds.
  • The synthesis claims add value by claiming key methods, although they face prior art for generic synthetic routes.

Potential Infringement and Non-Patent Barriers

  • Given the broad scope, third parties developing similar compounds must analyze the specific claim limitations to avoid infringement.
  • Non-patent barriers include regulatory approval requirements, patent expiration timelines, and licensing possibilities.

Summary Table of Claims and Scope

Category Details Number of Claims Comments
Composition Heterocyclic compounds with substitutions 1–5 Broad, covering multiple derivatives
Synthesis Synthetic routes and intermediates 6–8 Define methods, can be challenged by prior art
Therapeutic Methods of treatment, dosing 9–14 Focus on disease applications
Patent Family Related jurisdictions Multiple, including EP, JP, CN International protection consistent

Key Trends & Implications

  • The patent's broad composition scope indicates an attempt to monopolize a chemical class with therapeutic potential.
  • Similar patents could prompt challenges based on obviousness or prior art.
  • Key for competitors to analyze specific claim language for invalidity or design-around options.

Key Takeaways

  • US 10,918,649 covers a wide class of heterocyclic compounds with potential therapeutic uses.
  • Its claims include chemical structures, synthesis methods, and treatment methods, giving comprehensive control but also vulnerability to prior art.
  • The patent landscape is crowded with related patents that limit freedom to operate.
  • Enforcement will depend on the precise chemical structures and claimed methods.

FAQs

1. What types of diseases can the compounds in US 10,918,649 target?

The patent suggests applications in cancer, inflammation, and neurodegeneration, depending on the biological target modulation.

2. How broad is the chemical scope covered by the patent?

The first claim covers a wide class of heterocyclic compounds with specific substitutions, which can encompass thousands of derivatives.

3. Can competitors design around this patent?

Yes; focusing on structurally different compounds outside the defined substitution patterns can avoid infringement.

4. When does the patent expire?

Assuming maintenance fees are paid, it expires in 2031, but this may vary based on jurisdiction and legal challenges.

5. How does this patent compare to prior art?

It extends prior heterocyclic compounds by including newer substitutions and synthesis methods, but similar compounds may exist in earlier patents or literature, risking invalidity claims.


References

  1. U.S. Patent and Trademark Office. (2021). Patent No. 10,918,649. Retrieved from the USPTO database.
  2. World Intellectual Property Organization. (n.d.). Patent scope and legal status information for related family members.
  3. European Patent Office. (2022). Patent landscape reports on heterocyclic compounds targeting biological pathways.

More… ↓

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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 10,918,649 ⤷  Start Trial Y ⤷  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

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