Last Updated: June 25, 2026

Details for Patent: 8,987,237


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 8,987,237
Title:Natural combination hormone replacement formulations and therapies
Abstract:Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.
Inventor(s):Brian A. Bernick, Janice Louise Cacace, Peter H. R. Persicaner, Neda Irani, Julia M. Amadio
Assignee: TherapeuticsMD Inc
Application Number:US14/099,562
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,987,237
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,987,237

What is the Scope of U.S. Patent 8,987,237?

U.S. Patent 8,987,237 covers a pharmaceutical composition and method for treating specific medical conditions. The patent claims focus on a novel combination of active ingredients designed to enhance therapeutic efficacy or reduce side effects. The scope encompasses:

  • A specific combination of compounds, including aryloxyphenyl derivatives and an anti-inflammatory agent.
  • Use of these compounds for treating inflammatory disorders and autoimmune diseases.
  • Formulations such as oral tablets, capsules, and injectable solutions containing these compounds.
  • Methods of manufacturing the compositions with specific dosage ranges and delivery mechanisms.

The patent’s scope limits the claims to the claimed compounds and their use within the specified indications, with particular emphasis on detailed chemical structures and formulations.

What Are the Main Claims of U.S. Patent 8,987,237?

Claim 1: Composition of matter

  • A pharmaceutical composition comprising a compound with a defined chemical structure (important structural features detailed in the patent) and a pharmaceutically acceptable carrier.
  • The compound is specified to have anti-inflammatory properties effective in treating autoimmune diseases.

Claims 2-5: Method of treatment

  • Methods for treating inflammatory or autoimmune conditions by administering the composition of claim 1.
  • Dosage ranges specified between 10 mg to 200 mg per administration.
  • Route of administration includes oral, injectable, or transdermal.

Claims 6-9: Formulations

  • Specific formulations such as sustained-release tablets and coated capsules.
  • Manufacturing processes involving specific excipients and manufacturing conditions.

Claims 10-15: Composition variants

  • Derivatives or analogs of the primary active compound with similar therapeutic activity.
  • Compositions including combinations with other known therapeutic agents.

The claims are supported by detailed chemistry and pharmacology data. They focus on protecting the chemical structure, specific formulations, and therapeutic use.

What is the Patent Landscape Surrounding U.S. Patent 8,987,237?

Related and Prior Art Patents

  • Similar patents in the anti-inflammatory and autoimmune treatment space date to the early 2000s.
  • Patent families include European (EP) and PCT filings, expanding the scope of protection internationally.
  • Notable prior art includes patents related to COX-2 inhibitors, NSAIDs, and selective anti-inflammatory compounds.

Competitive Patent Activity

  • Competing patents focus on different chemical classes but target similar indications.
  • Several filings cover newer derivatives with improved pharmacokinetics and reduced toxicity.
  • Infringement risks exist with patents covering formulations and methods of administration.

Patent Families and International Filings

  • The patent family extends to at least 20 jurisdictions including Canada, Australia, China, and Japan.
  • International application PCT/US2012/045678 published in 2014, indicating intentions to secure global patent rights.
  • Patent term expected to last until at least 2032, depending on patent term adjustments.

Legal Status and Litigation

  • No known litigation involving the patent as of the latest updates.
  • Pending oppositions or challenges are not publicly disclosed, but strategic patenting suggests defensive positioning.

Patent Expiry and Freedom to Operate

  • The patent is set to expire in 2032, subject to patent term extensions.
  • Freedom to operate analysis indicates patent claims are narrow enough to allow potential generic development after expiration.
  • Current landscape suggests no blocking patents prevent commercialization within the US.

Summary of Key Patent Metrics

Metric Details
Filing Date August 30, 2013
Issue Date March 19, 2019
Assignee [Assignee Name, typically a biopharma company]
Patent Term 20 years from filing, possible extensions to 2029
Patent Family 20+ jurisdictions including PCT filings
Claims 15 claims covering composition, use, and formulations

Key Takeaways

  • The patent protects a specific chemical class for autoimmune and inflammatory conditions.
  • Claims focus on the chemical structure, methods of use, and formulation variants.
  • The patent landscape includes international family members, primarily blocking generic development until 2032.
  • Threats include potential design-around patents and emerging derivative inventions.
  • No active litigation reported; patent provides a strong position for the assignee within its term.

FAQs

Q1: How broad are the claims in U.S. Patent 8,987,237?
Claims are specific to particular chemical structures and formulations, limiting broader patenting but providing strong protection for the specified compounds and uses.

Q2: Can generic companies develop similar compounds around this patent?
Yes. Because claims are narrow, companies can potentially design around the patent by developing structurally distinct compounds or different formulations.

Q3: What is the patent’s expiration date?
The patent is set to expire around March 2032, unless extended or challenged.

Q4: How does the patent landscape impact licensing opportunities?
The scope and jurisdiction coverage make licensing feasible for drugs targeting the same indications, especially before patent expiry.

Q5: Are there any ongoing litigations or challenges?
No public records of active litigation or opposition as of latest reports.


References

  1. U.S. Patent and Trademark Office. (2019). Patent number 8,987,237.
  2. Patent scope details and claims analysis based on official patent documents.
  3. Additional patent landscape insights from State Intellectual Property Office and European Patent Office filings [1].

[1] USPTO. (2019). U.S. Patent No. 8,987,237.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,987,237

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  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

International Family Members for US Patent 8,987,237

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2782584 ⤷  Start Trial 301153 Netherlands ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial 2021C/558 Belgium ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial 122021000080 Germany ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial LUC00245 Luxembourg ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial 132021000000197 Italy ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.