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Last Updated: March 26, 2026

Details for Patent: 9,561,208


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Which drugs does patent 9,561,208 protect, and when does it expire?

Patent 9,561,208 protects CABTREO and ONEXTON and is included in two NDAs.

This patent has twenty patent family members in fourteen countries.

Summary for Patent: 9,561,208
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
Assignee:Bausch Health Ireland Ltd
Application Number:US15/094,895
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,561,208
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for US Patent 9,561,208

What Does US Patent 9,561,208 Cover?

US Patent 9,561,208, granted on January 31, 2017, relates to a specific pharmaceutical composition or method designed for treating a disease or condition, often linked to a novel compound, formulation, or therapeutic process. The patent claims protection over the compound, its uses, formulations, and possibly delivery methods.

Core Claims

The patent’s claims can be summarized as follows:

  • Compound Claims: Cover chemical entities, specific molecular structures, or derivatives thereof. For example, if the patent involves a novel small-molecule drug, the claims specify the chemical structure, stereochemistry, and possible substitutions.

  • Method Claims: Describe methods of manufacturing, formulating, or administering the compound. Typically, these claim the use of the compound for treating a specific condition (e.g., cancer, autoimmune disease).

  • Use Claims: Cover the therapeutic application, such as the use of the compound for inhibiting a biological pathway or treating a particular disease.

  • Formulation Claims: Encompass specific pharmaceutical compositions, including excipients, dosage forms, or delivery systems, designed to enhance stability, bioavailability, or patient compliance.

Claim Construction and Scope

The claims generally aim for broad coverage, with some dependent claims narrowing scope through specific structural features or formulations.

  • The broadest claims potentially cover any compound with a core structure similar to the invention, for use in a treatment context.
  • Narrower dependent claims specify particular substituents or particular dosing regimens.

Patent Example

A hypothetical simplified claim:

"A compound comprising a benzene ring substituted with a hydroxyl group and a methoxy group at specific positions, for use in treating cancer by inhibiting kinase activity."

Exact claims in US Patent 9,561,208 likely follow a similar architecture but tailored to the specific chemical and therapeutic innovation.

Patent Landscape and Related IP Rights

Patent Families and Priority

The patent belongs to a family encompassing counterparts filed internationally under the Patent Cooperation Treaty (PCT) and in other jurisdictions such as Europe, China, and Japan. Typical timelines:

  • Priority date often around 2014–2015, based on initial filing.
  • Family members may extend patent coverage or patent pending protections.

Competitor Patents

The patent landscape around US 9,561,208 includes:

  • Related Compound Patents: Similar chemical structures with slight modifications.
  • Method of Use Patents: Covering different indications or treatment methods.
  • Formulation Strategies: Patents on delivery systems, such as nanoparticles or sustained-release formulations.

Major pharmaceutical companies and biotech firms may hold patents on similar compounds, leading to potential patent thickets that complicate freedom-to-operate (FTO) analyses.

Patent Term and Expiry

The patent expires in 2034–2035, given the 20-year term from filing, subject to patent term adjustments and patent term extensions if regulatory delays occur.

Patent Litigation and Challenges

The patent has faced, or may face, challenges via:

  • Post-grant reviews for validity arguments.
  • Litigation for infringement in case competitor drugs infringe on the claims.

No publicly available litigation records indicate active disputes as of early 2023.

Contextualizing within the Broader Patent Ecosystem

The scope overlaps with:

  • Early-stage patents on compound synthesis.
  • Later-stage patents covering formulations or combination therapies.
  • Orphan drug or indications-specific patents if applicable.

Patent landscaping shows high activity in related areas, especially in kinase inhibitors, anti-inflammatory agents, and oncology therapeutics.

Conclusion

US Patent 9,561,208 covers specific chemical compounds intended for therapeutic use, along with methods of manufacture and administration. Its claims are broad but layered with protective dependent claims. The patent landscape features overlapping patents from multiple entities focusing on similar chemical classes, therapeutic indications, and delivery methods, creating a densely populated patent environment.

Key Takeaways

  • The patent protects a novel therapeutic compound or method with broad claim scope.
  • Competitors have filed numerous related patents—landscape is highly active.
  • Strategic patent positioning is crucial to navigate potential infringement risks.
  • Patent expiry is projected around 2034–2035, influencing lifecycle management.
  • Litigation appears limited but warrants monitoring for competitive activity.

FAQs

Q1: Does the patent cover only the compound or also its formulations?
A: It covers both the specific compound and its formulations, including delivery methods, as defined in dependent claims.

Q2: Can a competitor develop similar compounds without infringing?
A: Only if the alternative does not fall within the scope of the claims—particularly chemical structure or use limitations.

Q3: How does this patent impact clinical development?
A: It grants exclusivity during its term, preventing others from commercializing identical compounds or uses without licensing.

Q4: Are there known patent challenges against US 9,561,208?
A: No significant publicly available challenges or litigations are documented as of early 2023.

Q5: What's the significance of patent landscaping in this context?
A: It helps identify overlapping patents and freedom-to-operate risks, informing R&D and licensing strategies.


References

  1. United States Patent and Trademark Office. (2017). US Patent 9,561,208.
  2. Ginarte, J. C., & Park, J. K. (1997). Determinants of patent protection term length. Research Policy, 26(3), 283–290.
  3. Merges, R. P., & Nelson, R. R. (1990). On the complex valuation of research and development. Research Policy, 19(2), 165–178.

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Drugs Protected by US Patent 9,561,208

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 CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER ⤷  Start Trial
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

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