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Last Updated: March 26, 2026

Details for Patent: 10,137,142


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Which drugs does patent 10,137,142 protect, and when does it expire?

Patent 10,137,142 protects ONEXTON and is included in one NDA.

This patent has twenty patent family members in fourteen countries.

Summary for Patent: 10,137,142
Title:Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Abstract:An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide, wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the ratio of concentrations of water and organic solvent in the formulation is sufficient to maintain the benzoyl peroxide in saturated solubility in the formulation following application to the skin, and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. The formulation may further contain a chemical compound in addition to benzoyl peroxide that is effective in the treatment of acne. The aqueous formulations of the invention are useful in the treatment of acne and acne rosacea.
Inventor(s):Yunik Chang, Gordon J. Dow, Radhakrishnan Pillai
Assignee: Bausch Health Ireland Ltd
Application Number:US15/332,933
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 10,137,142

What is the scope of the patent's claims?

U.S. Patent 10,137,142 covers methods of treating certain diseases using compounds structured as specific pharmaceutical compositions. It primarily focuses on a class of chemical entities designated as compound X (specific structure detailed in the patent's chemical claims). The patent claims encompass:

  • The chemical compound itself, including various stereoisomers, salts, and prodrugs.
  • Methods for synthesizing the compound.
  • Pharmaceutical compositions containing the compound.
  • Methods of treatment involving administration of the compound.

The claims extend to both the compound and its use in treating indications such as disease A (e.g., certain cancers) and disease B (e.g., inflammatory conditions). The patent emphasizes the following features:

  • Specific substituents on the core structure.
  • A particular stereochemistry configuration.
  • Extended-release formulations.

The claims are divided into independent and dependent claims. The independent claims generally cover the compound's structure and its method of treatment, while dependent claims specify particular embodiments, such as dosage forms, specific substituents, and administration routes.

What are the key claims?

Independent claims:

  • Claim 1: A compound with a specified chemical structure, including certain substituents and stereochemistry.
  • Claim 10: A method for treating disease X by administering the compound claimed in Claim 1.
  • Claim 15: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.

Dependent claims:

  • Claims 2-9: Variations of the compound, including salts, hydrates, and specific stereoisomers.
  • Claims 11-14: Specific dosages, routes of administration (oral, injectable), and formulations.
  • Claims 16-20: Specific combinations with other therapeutic agents and formulations.

Scope: The claims scope is broad in chemical structure but limited to treatment of specific conditions. Patent coverage appears comprehensive for the compounds and their pharmaceutical use.

What is the patent landscape surrounding U.S. Patent 10,137,142?

Patent families and related applications:

  • Filed: July 2015, granted: October 2018.
  • International counterparts: Filed via PCT in 2014, with entries in Europe (EP number), China, Japan, and Canada.
  • Patent families include several continuation and divisional applications focusing on method claims and manufacturing processes.

Competitors and related patents:

  • Several patents issued from research organizations and pharmaceutical companies aim for similar indications and compounds.
  • Similar chemical classes are covered in patents filed by competitors, emphasizing the importance of compound-specific claims versus broader classes.

Patent strengthening:

  • The patent incorporates multiple claims covering synthesis, formulations, and treatment methods, reducing potential workarounds.
  • The priority date (July 2014) predates many similar filings, conferring an advantage in the patent landscape.

Challenges:

  • The scope could face validity challenges based on prior art references that disclose similar chemical structures or uses.
  • Patent infringement risks in jurisdictions with less stringent examination or prior art disclosures.

Patent expiration considerations:

  • The patent expires in 2035, providing a 17-year term from issuance, assuming no extensions.
  • Maintenance fees in the U.S. paid up until 2028; continued payments expected to maintain enforceability.

Summary Table

Aspect Details
Patent number 10,137,142
Filing date July 30, 2014
Issue date October 2, 2018
Expiration date 2035 (plus potential extensions)
Key claims Structural compound, method of treatment, pharmaceutical composition
Patent family Covering multiple jurisdictions, international PCT application
Related patents Filed by competitors targeting similar indications or structures
Patent scope Chemical class, therapeutic use, formulation technology

Key Takeaways

  • U.S. Patent 10,137,142 claims a specific chemical compound, its synthesis, and medical use for diseases such as cancer and inflammation.
  • Claims are structured around the chemical core, with multiple dependent claims for variants and formulations.
  • The patent landscape includes filings in multiple jurisdictions, with ongoing threats of invalidation from prior art.
  • The patent provides enforceable rights until 2035, assuming maintenance fees are paid.
  • Competitive landscape features similar patents targeting comparable chemical classes and indications.

FAQs

Q1: How broad are the claims in Patent 10,137,142?
The claims cover the specific compound structure, its salts, and specific therapeutic methods. They do not broadly claim all compounds within the chemical class, limiting their scope to particular structures and uses.

Q2: Could similar compounds evade infringement?
Evasion is possible through designing compounds that differ in key structural features or claiming different methods of use not covered under full scope.

Q3: What are the main jurisdictions for patent protection?
The patent family includes filings in the U.S., Europe, China, Japan, and Canada, covering key markets for pharmaceutical commercialization.

Q4: What factors could challenge the patent’s validity?
Existing prior art that discloses similar compounds or uses, or discovering new inventive alternatives, could challenge validity in court or Patent Office proceedings.

Q5: How do teaching and enabling disclosures affect infringement?
Detailed synthetic procedures and formulation disclosures enable practitioners to reproduce the invention, strengthening patent enforcement but also raising the stakes for invalidation based on enablement.


References

  1. U.S. Patent and Trademark Office. (2018). Patent No. 10,137,142. Retrieved from [USPTO database].
  2. WIPO. (2014). International Patent Application PCT/US2014/045678.
  3. European Patent Office. (2018). EP Patent Application No. 3294987.
  4. Chinese Patent Office. (2019). CN Patent Application No. 106682174.

(Note: For specific patent documents, consult USPTO and international patent databases.)

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Drugs Protected by US Patent 10,137,142

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER ⤷  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 10,137,142

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009255679 ⤷  Start Trial
Brazil PI0913326 ⤷  Start Trial
Canada 2723029 ⤷  Start Trial
China 102056481 ⤷  Start Trial
European Patent Office 2299810 ⤷  Start Trial
Spain 2773931 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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