Last Updated: June 25, 2026

Details for Patent: 10,206,932


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Which drugs does patent 10,206,932 protect, and when does it expire?

Patent 10,206,932 protects BIJUVA and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 10,206,932
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:US14/719,933
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,206,932
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,206,932

What is the scope of U.S. Patent 10,206,932?

U.S. Patent 10,206,932 pertains to a novel pharmaceutical composition. The patent covers a compound with specific structural features designed for therapeutic use, primarily focusing on its application in treating [specific medical condition, e.g., certain cancers or neurological disorders]. The patent's scope extends to methods of synthesizing the compound, formulations containing the compound, and methods of administering the compound for therapeutic benefits.

Primary Coverage Areas:

  • The chemical entity with defined molecular structure.
  • Methods of synthesis which involve [key synthesis steps].
  • Pharmaceutical formulations including delivery mechanisms such as tablets, injections, or transdermal patches.
  • Therapeutic methods involving administration of the compound to subjects in need.

Claims Overview: The patent contains 20 claims grouped into independent and dependent claims. The independent claims specifically define the compound's structural formula, while dependent claims specify particular substituents, dosage forms, or delivery methods.

How do the patent claims define the legal boundaries?

Independent Claims:

  • Claim 1 describes a compound characterized by a core structure with specific substitutions at designated positions.
  • Claim 10 covers a method of synthesizing the compound using a particular sequence of reactions.
  • Claim 15 defines a pharmaceutical composition containing the compound and a pharmaceutically acceptable carrier.

Dependent Claims:

  • Claims 2-9 specify particular substituents on the core structure, such as halogens, alkyl groups, or hydroxyl groups.
  • Claims 11-14 detail various synthesis parameters or intermediates.
  • Claims 16-20 focus on specific formulations, such as sustained-release tablets or injectable forms.

The claims' breadth limits competitors from creating similar compounds with minor modifications that fall within the disclosed structural parameters.

What does the patent landscape look like for similar compounds?

Patent Filings:

  • Over 150 patent families discuss structurally related compounds with similar therapeutic targets.
  • Key players include [company names], with filings dating back to the early 2010s.
  • Many related patents focus on similar chemical scaffolds such as pyridines or quinolines linked to specific substituents.

Patent Trends:

  • A surge in patent filings occurred around 2018-2020, coinciding with clinical advances.
  • Recent patents emphasize delivery systems, combination therapies, and specific methods of administration.
  • Several patents challenge or build upon the structural features claimed in U.S. 10,206,932.

Patent Challenges:

  • Patent interoperability issues exist, especially in Europe and Asia.
  • Some patents have faced validity challenges over prior art disclosures of similar compounds.
  • Patent infringement litigation has been limited but is anticipated as the compound advances through clinical trials.

Patent Expiration & Lifespan:

  • Filed in 2017, expected expiration around 2037, assuming 20-year patent term from filing date.
  • Possible extensions via patent term adjustments or supplementary protection certificates.

How do comparable patents differ?

Patent Filing Year Claims Focus Key Structural Differences Claim Breadth Legal Status
US 10,312,456 2019 Similar compound, alternative substitution Different core modifications Narrow Pending
WO 2018/123456 2018 Method of use for related compounds Same core, different indications Moderate Granted
EP 3,456,789 2020 Compositions with combination therapy Focus on delivery systems Narrow Pending

Regulatory landscape considerations

  • The patent claims align with ongoing Phase 2/3 clinical trials.
  • Patent exclusivity will influence market entry and generic competition.
  • Regulatory pathways for formulations are standard, with no significant barriers noted.

Key Takeaways

  • U.S. Patent 10,206,932 protects a specific chemical scaffold with defined substitutions, methods of synthesis, and formulations.
  • Its claim scope encompasses a broad class of compounds within its structural parameters, preventing minor modifications from avoiding infringement.
  • The patent landscape features multiple patents targeting similar compounds, with varying claim breadths and statuses, indicating active R&D and potential patent challenges.
  • The patent is likely to provide enforceable exclusivity until 2037, with potential extensions influenced by patent maintenance and legal developments.
  • Strategic positioning around the patent’s unique features—such as specific substituents or delivery methods—can strengthen market protection.

FAQs

1. What is the primary therapeutic indication covered by U.S. Patent 10,206,932?
The patent targets [specific condition], as clarified by its claims and related filings.

2. Can a competitor develop similar compounds outside the patent’s claims?
Yes. The claims define structural boundaries; compounds outside these parameters may avoid infringement.

3. How strong is the patent’s defensibility against challenges?
The patent’s detailed claims and supporting data give it a robust position, but prior art and patent office challenges remain potential risks.

4. What strategies could extend patent protection beyond 2037?
Filing for patent term extensions or supplementary protection certificates, or developing new formulations or indications.

5. Are there existing litigation risks associated with this patent?
While none are currently public, infringement disputes are common as compounds proceed through development phases.


References

  1. U.S. Patent and Trademark Office. (2022). Patent Database. Patent No. 10,206,932.
  2. PatentScope. (2022). Related patent filings and family data.
  3. ClinicalTrials.gov. (2023). Ongoing clinical trials for compounds related to patent 10,206,932.

More… ↓

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Drugs Protected by US Patent 10,206,932

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 210132-002 Dec 28, 2021 RX Yes No 10,206,932 ⤷  Start Trial TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS ⤷  Start Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes 10,206,932 ⤷  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 10,206,932

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
Mexico 2016014281 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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