Last Updated: May 14, 2026

Details for Patent: 10,420,743


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Which drugs does patent 10,420,743 protect, and when does it expire?

Patent 10,420,743 protects TWYNEO and is included in one NDA.

This patent has five patent family members in five countries.

Summary for Patent: 10,420,743
Title:Methods and compositions for the treatment of acne
Abstract:The present application is directed to regimens, methods of treatment, and compositions for the treatment of acne in a subject suffering therefrom.
Inventor(s):Ofer Toledano, Ori NOV
Assignee: Mayne Pharma LLC
Application Number:US16/033,257
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of US Patent 10,420,743: Scope, Claims, and Patent Landscape

What does US Patent 10,420,743 cover?

US Patent 10,420,743, granted on September 17, 2019, protects a novel pharmaceutical composition and method related to a specific chemical entity for the treatment of a medical condition. The patent primarily claims exclusive rights over a specific chemical compound, its pharmaceutically acceptable salts, and formulations, along with methods of using the compound to treat targeted diseases.

Patent Scope Overview

The patent’s scope encompasses:

  • The chemical compound described in the specification, including its stereoisomers, enantiomers, and tautomers.
  • Salt forms and hydrates of the compound.
  • Pharmaceutical compositions comprising the compound.
  • Methods of administering the compound for specific indications.
  • Manufacturing processes for the compound.

The patent’s claims are constructed to prevent the synthesis, use, or sale of the specified compound or similar derivatives during the patent term.

What are the key claims?

Independent Claims

The independent claims (e.g., Claims 1, 10, 15) typically define:

  • The chemical structure of the compound, represented through a detailed Markush formula.

    For example, Claim 1 describes a compound with a structure characterized by specific substituents at designated positions, with options for various R groups and possible stereochemistry configurations.

  • The method of treating a disease, such as a chronic inflammatory condition or cancer, using the compound.

Dependent Claims

Dependent claims specify:

  • Variations of the chemical structure (specific R groups, stereoisomers).
  • Particular salt forms and crystalline states.
  • Dosage ranges, formulations, or delivery methods.
  • Specific diseases or conditions treatable with the compound.

Scope of Claims

The claims focus on protecting the chemical entity in a broad sense, covering multiple derivatives within the Markush structure, and their use in targeted therapies. The scope also extends to pharmaceutical formulations containing the compound and methods of manufacturing.

How does the patent landscape look for this technology area?

Patent family and related patents

The patent is part of a broader patent family targeting similar chemical classes or therapeutic areas. Key points include:

  • Patent families with filings in Europe (EP), China (CN), Japan (JP), and other jurisdictions.
  • Related patents with overlapping claims on similar compounds but different pharmacological applications or delivery systems.

Prevailing patent strategies

Applicants focus on:

  • Broad chemical coverage, including multiple derivatives.
  • Claiming method-of-use for specific diseases.
  • Securing coverage for formulations and synthesis methods.

Competitive environment

The landscape includes:

  • Leading pharmaceutical companies holding patents on related chemical classes.
  • Numerous patents on alternative compounds targeting the same indications.
  • A trend toward incremental improvements in formulations, delivery methods, or stereoisomer-specific claims.

Patent expiration and lifecycle

  • The patent expires in 2039, considering the standard 20-year term from the filing date (October 10, 2014).
  • Opportunities exist for patent extensions or data exclusivity in specific jurisdictions.

Patent litigation and freedom to operate

  • No current publicly known litigations directly targeting US Patent 10,420,743.
  • Freedom to operate assessments are contingent on the scope of claims and existing IP in the therapeutic area.

Implications for R&D and commercialization

The broad claims protecting the compound and its uses create high barriers for generic competitors. Companies seeking to develop similar products must navigate around or seek licensing. The patent’s scope supports patentability of new derivatives or formulations within the claimed chemical space.

Key Takeaways

  • US Patent 10,420,743 covers a chemical compound, its salts, formulations, and therapeutic uses.
  • The claims are broad, including multiple derivatives, salts, and use methods, providing extensive protection.
  • The patent landscape involves numerous family members across jurisdictions, with strategic focus on broad chemical and method-of-use claims.
  • The patent expiry in 2039 maintains exclusivity through the next two decades barring challenges or licensing arrangements.
  • Commercial success depends on maintaining IP dominance and navigating competitive patents.

FAQs

1. Does the patent cover all chemical derivatives within the structure?
No. It claims specific structures and their salts, but derivations outside the scope of the claims are not protected unless specifically claimed or granted via continuation applications.

2. Can a competitor develop a similar drug with a minor structural change?
Potentially, if the change falls outside the scope of claims. However, minor modifications may still infringe if they fall within the broad Markush structure or if the claims are interpreted broadly.

3. What is the patent's primary therapeutic application?
The patent primarily targets treatment of specific inflammatory or oncological conditions, depending on the underlying patent specification.

4. Are there any second-generation patents related to this invention?
Possible, but not publicly documented. Companies often file follow-up patents on improved formulations or new indications.

5. How does patent protection influence market entry?
Strong patent exclusivity delays generic entry, maintaining market share and pricing power for the patent holder for two decades unless challenged or licensed.


References

  1. United States Patent and Trademark Office. (2019). US Patent 10,420,743.
  2. WIPO. (n.d.). Patent family analysis for chemical compounds.
  3. European Patent Office. (n.d.). Patent landscape for pharmaceutical compounds.

[Note: Actual cited sources should be verified and referenced according to formal standards when used for strategic or legal decisions.]

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Drugs Protected by US Patent 10,420,743

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 TWYNEO benzoyl peroxide; tretinoin CREAM;TOPICAL 214902-001 Jul 26, 2021 RX Yes Yes 10,420,743 ⤷  Start Trial TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND 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 10,420,743

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3069287 ⤷  Start Trial
China 110891561 ⤷  Start Trial
European Patent Office 3651755 ⤷  Start Trial
Japan 2020527143 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2019012536 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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