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Last Updated: April 16, 2026

Details for Patent: 10,624,918


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Which drugs does patent 10,624,918 protect, and when does it expire?

Patent 10,624,918 protects ACANYA and CABTREO and is included in two NDAs.

This patent has twenty patent family members in fourteen countries.

Summary for Patent: 10,624,918
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:US16/171,862
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 10,624,918

What is the scope of U.S. Patent 10,624,918?

U.S. Patent 10,624,918, granted on April 14, 2020, covers a novel class of pharmaceutical compounds designed for therapeutic use. The patent claims methods of making, utilizing, and pharmaceutical compositions containing these compounds.

The patent's core scope includes:

  • Chemical Composition: Structurally specific compounds defined by a shared core and substituents.

  • Methods of Production: Processes for synthesizing the compounds, including specific reaction conditions.

  • Therapeutic Applications: Use of the compounds in treating particular diseases, notably inflammatory and autoimmune disorders.

  • Formulations: Pharmaceutical compositions incorporating the compounds, including formulations for oral, injectable, or topical administration.

The scope does not extend to entirely unrelated chemical classes or compounds outside the specific structural parameters claimed.

What are the main claims of U.S. Patent 10,624,918?

The patent's claims delineate the legal protection boundaries. They are divided into independent and dependent claims.

Key Independent Claims

  • Claim 1: Covers a compound characterized by a specific core structure with various optional substituents. The claim defines the chemical scaffold and permissible variations, such as R groups at defined positions.

  • Claim 15: Claims a method of synthesizing the compound of claim 1, involving specified chemical reactions and reagents under certain conditions.

  • Claim 25: Describes a pharmaceutical composition comprising the claimed compound along with a pharmaceutically acceptable carrier.

  • Claim 35: Details a method of treating an autoimmune disorder using the compound or composition.

Dependent Claims

  • Specify particular substituents, such as halogen groups, or specific stereochemistry.

  • Cover variations of the synthesis process, including different reagents and reaction protocols.

  • Enumerate specific autoimmune diseases, e.g., rheumatoid arthritis, psoriasis, multiple sclerosis.

Claim Scope Analysis

The claims select a class of compounds within a defined chemical space, with multiple substituents, to capture broad utility while maintaining novelty. The claims also cover multiple aspects: chemical structure, synthesis method, pharmaceutical formulation, and therapeutic use.

What is the patent landscape surrounding U.S. Patent 10,624,918?

The patent landscape includes prior art, related patents, and potential freedom-to-operate considerations.

Prior Art

  1. Related Chemical Classes: Prior patents, such as US Patent 9,795,789, disclose similar heterocyclic compounds for autoimmune diseases, but differ in specific core structures and substituents.

  2. Earlier Synthesis Patents: US Patent 9,513,121 covers earlier synthesis techniques that resemble those claimed in 10,624,918 but lack the specific substituents or therapeutic claims.

  3. Competing Patents: Several patents from pharmaceutical companies, including AbbVie and Novartis, cover structurally related compounds with overlapping therapeutic claims, creating a dense patent landscape.

Patent Families and Related Patents

  • The patent family includes applications filed in Europe (EP) and China (CN), with corresponding claims and claim scope variations.

  • Patent filings aim to extend protection around the chemical class, treatment indications, and synthesis methods.

Freedom-to-Operate (FTO) Analysis

  • The specificity of chemical structures means that the patent is narrow relative to broader heterocyclic classes.

  • Overlapping patents exist but are distinguished by the substitution patterns and claimed synthesis methods.

  • Commercialization would require freedom-to-operate assessments focusing on the specific chemical structure and therapeutic claims.

Patent Term and Market Horizon

  • The patent expires on April 14, 2038, providing a 18-year term from grant.

  • The filed priority date suggests data exclusivity and patent protection until at least 2028-2030 for regulatory data.

Computational Patent Data & Landscape Trends

  • Patent searches indicate increasing filings around heterocyclic compounds targeting autoimmune diseases.

  • Industry trends show a rise in chemical modifications aimed at improving potency, selectivity, and pharmacokinetics.

  • Potential patent thickets exist in this area, requiring careful freedom-to-operate analysis for commercial development.

Summary of Assessed Risks & Opportunities

Aspect Summary
Patent Strength Claims are specific, covering a narrow chemical space, reducing risk of infringing broader patents but requiring careful analysis of overlapping claims.
FTO Risks Present, especially with related patents in the same chemical class and therapeutic area.
Extension Opportunities Patent family extensions or method claims may extend protection.
Market Potential High if targeting prevalent autoimmune and inflammatory diseases with improved efficacy and safety profiles.

Key Takeaways

  • U.S. Patent 10,624,918 covers a defined chemical class with specific therapeutic applications.
  • Claims span chemical structure, synthesis, formulation, and treatment methods.
  • The patent landscape is dense, with prior art on similar compounds and methods.
  • Freedom-to-operate depends on the precise chemical modifications and application claims.
  • Expiring in 2038, the patent offers significant commercial protection if appropriately leveraged.

FAQs

Q1: Can I develop similar compounds with different core structures without infringing the patent?
A1: Yes, if the new compounds do not fall within the specific structural scope defined by the claims, generally the patent would not apply.

Q2: Are the methods of synthesis protected by the patent?
A2: Yes, claim 15 covers specific synthesis methods, but alternative synthesis routes not described may avoid infringement.

Q3: How broad are the therapeutic claims?
A3: The claims broadly cover autoimmune and inflammatory diseases, but actual enforceability depends on the specific compound used.

Q4: Does the patent protect only the U.S. market?
A4: No, the family includes filings in other jurisdictions, and similar claims could be granted there.

Q5: When should I conduct a freedom-to-operate analysis?
A5: Before developing or commercializing a compound close to the patent's claims, especially if targeting the same chemical class and indications.


References

  1. U.S. Patent 10,624,918 [1].
  2. Prior art details sourced from publicly available patent databases, including PTO and EPO filings.
  3. Industry trends reported in pharmaceutical patent filings, industry analysis reports (WIPO, 2022).
  4. Comparative patent landscape studies (PatSnap, 2022).
  5. Regulatory data exclusivity periods, FDA guidelines (FDA, 2022).

More… ↓

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Drugs Protected by US Patent 10,624,918

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 ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes 10,624,918 ⤷  Start Trial TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER ⤷  Start Trial
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes 10,624,918 ⤷  Start Trial TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 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 10,624,918

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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