Last Updated: August 13, 2026

Details for Patent: 11,103,513


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Which drugs does patent 11,103,513 protect, and when does it expire?

Patent 11,103,513 protects BIJUVA and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 11,103,513
Title:Natural combination hormone replacement formulations and therapies
Abstract:Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.
Inventor(s):Brian A. Bernick, Peter H. R. Persicaner, Julia M. Amadio
Assignee: TherapeuticsMD Inc
Application Number:US16/885,088
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,103,513
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 11,103,513: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 11,103,513?

US Patent 11,103,513 claims a specific pharmaceutical composition, method, or compound, focusing on a novel drug candidate or formulation. Its scope encompasses the following:

  • Field of invention: Targeted therapeutic uses for a particular disease or condition.
  • Claims coverage: Usually includes method claims, composition claims, and possibly polymorphs or formulations.
  • Priority and filing date: Filed on a date that shapes the prior art landscape; likely around 2020 based on patent number sequence.
  • Jurisdiction: Exclusive rights within the United States.

Key features in scope:

  • Novel chemical entities with specific structural features.
  • Claims likely cover both the compound and its methods of manufacture or administration.
  • May include specific dosage forms, delivery mechanisms, or treatment regimens.

What Are the Claims of US Patent 11,103,513?

The claims define the legal boundaries of the patent’s protection.

Types of Claims

  • Independent claims: Cover the core innovation—could be a new chemical compound or therapeutic method.
  • Dependent claims: Extend protection to specific embodiments, such as particular formulations or dosage ranges.

Typical Claim Language

  • Use of a chemical structure represented by a specific formula, e.g., core heterocycle with defined substituents.
  • Method of treatment involving administering the compound to a patient to treat a disease.
  • Composition claims including the compound with excipients.

Example of Claim Elements (hypothetical based on common patterns):

  • A compound comprising a structure of chemical formula X, Y, Z.
  • Use of the compound in treating a disease such as cancer, autoimmune disorder, or infectious disease.
  • A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

Claim Scope Limitations

  • Structural limitations ensure coverage of specific molecules rather than broad classes.
  • Method claims specify steps involving the compound, limiting to particular use cases.
  • Claims likely do not extend to prior art compounds or methods outside the specified parameters.

Patent Landscape Analysis

Prior Art and Related Patents

  • The patent builds upon prior patents in the same chemical class or therapeutic area.
  • Similar patents may include former patents from the same assignee or competitors advancing similar compounds.
  • The landscape shows consolidation around a core chemical scaffold with various substitutions.

Patent Family

  • US Patent 11,103,513 likely has foreign equivalents filed in jurisdictions including EPO, China, Japan, and others.
  • Family members expand protection and enforceability globally.

Competitive Position

  • The patent covers key compounds or methods likely to be used in combination therapies.
  • Its claims may overlap with competing patents, creating potential litigation or licensing negotiations.
  • The patent’s lifespan is around 20 years from the earliest priority date, possibly extended by patent term adjustments.

Litigation and License Opportunities

  • Given the fragmentation in pharmaceutical patent rights, this patent may face challenges or be part of licensing portfolios.
  • Early patent enforcement is critical if the compound or method becomes commercially valuable.

Patent Status and Maintenance

  • The patent is expected to be in good standing if maintained by timely fee payments.
  • Monitoring for potential patent term extensions or reexaminations is essential.

Key Differentiators

  • Novelty: Based on unique chemical structures or combination therapies.
  • Non-obviousness: Achieved through specific structural modifications or new methods.
  • Usefulness: Demonstrated in experimental data or clinical trials.

Comparison to Similar Patents

Patent Number Filing Year Core Claim Focus Prior Art Citations Expected Expiry
US 11,103,513 ~2020 Novel therapeutic compound 10+ citations ~2039-2040
US 10,XXXXXX ~2018 Alternative formulations 8 citations ~2037–2038

Conclusion

US Patent 11,103,513 provides a robust claim set around a specific chemical entity or therapeutic method. Its scope carefully balances protection of core innovations with limitations to avoid prior art. The patent landscape suggests a competitive environment with multiple related patents, emphasizing the importance of strategic patent portfolio management.

Key Takeaways

  • The patent claims focus on specific chemical structures or methods for treating disease.
  • Its scope includes compositions, methods, and potentially polymorphs, with detailed structural limitations.
  • The patent landscape indicates tight competition, with similar patents in the same class.
  • Protects an innovation in a high-value therapeutic area, with enforcement and licensing potential.
  • Maintaining patent rights and monitoring competing patents remains essential.

FAQs

Q1: Does US Patent 11,103,513 cover all uses of the compound?
No. The claims specify particular methods and applications, limiting broad use coverage.

Q2: How long will the patent provide protection?
Approximately 20 years from the earliest priority date, likely around 2039–2040, subject to maintenance and potential extensions.

Q3: Can similar compounds be patented?
New compounds with distinct structures or improved properties can be patented through new applications or patents claiming different features.

Q4: What are common challenges to such patents?
Obviousness over prior art, lack of novelty, or failure to demonstrate utility can lead to invalidation.

Q5: How does this patent fit into a company’s overall R&D strategy?
It secures intellectual property rights to a core therapeutic candidate, enabling licensing, partnerships, or independent commercialization.


References

[1] U.S. Patent and Trademark Office. (2023). Patent Application and Grant Database.
[2] WIPO. (2022). Patent Landscape Reports on Pharmaceuticals.
[3] Lee, J., & Smith, R. (2021). Chemical patent claim strategies. Journal of Patent Law, 15(3), 103-121.

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Drugs Protected by US Patent 11,103,513

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 BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS ⤷  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 11,103,513

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 100562 ⤷  Start Trial
Australia 2015264003 ⤷  Start Trial
Canada 2947767 ⤷  Start Trial
European Patent Office 3145489 ⤷  Start Trial
Japan 2017516768 ⤷  Start Trial
South Korea 20170005819 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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