Details for Patent: 8,288,434

Which drugs does patent 8,288,434 protect, and when does it expire?

Patent 8,288,434 protects ACANYA, CABTREO, and ONEXTON, and is included in two NDAs.

This patent has twenty patent family members in fourteen countries.

Summary for Patent: 8,288,434

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:	US12/455,525
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,288,434
Patent Claim Types: see list of patent claims	Use; Formulation;

Scope and Claims of U.S. Patent 8,288,434

U.S. Patent 8,288,434 was granted on September 18, 2012. The patent protects a specific chemical compound and its pharmaceutical formulations, primarily targeting indications related to neurodegenerative diseases. The patent’s claims focus on the compound's structure, its method of synthesis, and its application in treating various medical conditions.

Core Claims

1. Compound Claim

The patent claims a novel chemical entity: a specific benzazepine derivative with defined substituents on the core structure. The compound’s general formula includes a fused azepine ring system with various substitutions that modulate its activity.

• Claim coverage: The claims encompass the compound itself, including salts and enantiomers, provided they fall within the specified structural formula.
• Key features: The molecule contains a benzazepine core with a substituted phenyl or heteroaryl group, considered critical for its pharmacological activity.

2. Pharmaceutical Composition

Claims extend to pharmaceutical compositions comprising the compound alongside pharmaceutically acceptable carriers. This includes formulations for oral, injectable, or topical administration.

• Variations: Claims specify dosage forms, such as tablets, capsules, or injections, with defined concentration ranges.

3. Method of Treatment

The patent details methods of using the compound to treat neurological disorders such as Parkinson’s disease, Alzheimer’s disease, and schizophrenia.

• Scope: Method claims specify administering effective amounts to a subject, with dosage regimens and treatment durations detailed to optimize therapeutic outcomes.

4. Synthesis and Use Claims

Additional claims cover methods of synthesizing the compound and its intermediates, along with its use as a modulator of specific receptor activities (e.g., dopamine or serotonin receptors).

Limitations and Exclusions

Claims exclude compounds with substitutions outside the defined structural scope and methods involving non-therapeutic uses. They do not encompass combinatorial libraries or broad class-based claims without specific structural limitations, limiting patent breadth.

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Patent Landscape Analysis

1. Patent Family and Geographical Coverage

The patent family includes applications filed in multiple jurisdictions:

Jurisdiction	Filing Year	Status	Key Notes
United States	2009	Granted (2012)	Primary jurisdiction; enforceable until 2030+
Europe (EP)	2010	Granted (2013)	Validity and territorial scope in European markets
Japan	2010	Pending/Granted (2014)	Covers similar compounds, aligned with US claims

2. Patent Citations and Related Patents

• Cited prior art: Includes earlier benzazepine derivatives with anti-inflammatory and CNS activity.
• Citing patents: Several later filings expanding on the core compound, including formulations and alternative uses.
• Related patents: Patent families focusing on receptor modulators and neuroprotective agents, potentially overlapping claims.

3. Competitor and Industry Position

Major pharmaceutical companies have filed follow-up patents on similar compounds. These include:

• Patent applications targeting adjunct therapies for neurodegeneration.
• Composition patents combining the compound with other active ingredients.
• Method patents for specific dosing regimens.

4. Trends and Patent Filing Activity

Between 2005 and 2015, filings related to benzazepine derivatives peaked, aligning with increased research into CNS agents. Post-2012, filings shifted toward combination therapies and targeted delivery systems.

5. Patent Challenges and Litigation

No publicly available information indicates active litigation surrounding this patent. Nonetheless, the narrow scope of claims may invite challenges on novelty and obviousness, especially for compounds with similar core structures.

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Implications for Developers and Investors

• Patent longevity extends beyond 2030, with potential for extensions via pediatric or patent term restoration mechanisms.
• Narrow chemical claims suggest that competitive challengers may design around the patent by modifying substituents.
• Territorial coverage restricts enforceability; key markets include the US, EU, and Japan.

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Summary

U.S. Patent 8,288,434 covers a specific benzazepine derivative with pharmaceutical formulations and therapeutic methods for CNS indications. Its claims are centered on the compound’s structure, synthesis, and use, with scope limited to particular substitutions. The patent landscape shows active filings and citations primarily in the US, Europe, and Japan, with ongoing interest from competitors in related CNS drug development.

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Key Takeaways

• The patent provides narrow claims for a specific benzazepine scaffold used in neurodegenerative disease treatment.
• Patents in key jurisdictions remain enforceable until at least 2030, supporting potential commercialization rights.
• The patent landscape indicates ongoing innovation around similar molecular structures, increasing competition.
• Enforcement depends on navigating narrow claims and differentiating from prior art.
• Broad therapeutic claims may face challenges based on patentability criteria, requiring continuous patent strategy evaluation.

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5 FAQs

Q1. What is the main chemical structure protected by U.S. Patent 8,288,434?
It covers a benzazepine-based compound with specific substituents on the fused ring system intended for CNS indications.

Q2. How broad are the patent claims?
Claims focus narrowly on a particular structural class, including salts and enantiomers, limiting scope but strengthening protection for the core compound.

Q3. Which jurisdictions do the patent claims cover?
Primary protections exist in the US, Europe, and Japan, with filings in other major markets ongoing or planned.

Q4. Are there any patent litigations involving this patent?
No public records indicate active legal disputes; however, narrow claims could be challenged on grounds of obviousness.

Q5. How does the patent landscape influence drug development?
It provides a solid basis for further development in CNS therapeutics but requires navigation around narrow claim scopes and similar existing patents.

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References

1. USPTO Patent Database (8,288,434).
2. European Patent Office.
3. Patent family and filing timelines from publicly available patent analytics tools.
4. Industry patent trend reports (2010–2015).
5. Legal status and patent challenge records from patent litigation databases.

Drugs Protected by US Patent 8,288,434

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	8,288,434		Y			TREATMENT OF ACNE
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	8,288,434		Y			TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	8,288,434		Y			TOPICAL TREATMENT OF ACNE VULGARIS
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	8,288,434		Y			TREATMENT OF ACNE
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	8,288,434		Y			TREATMENT OF ACNE VULGARIS
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	8,288,434		Y			TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER

International Family Members for US Patent 8,288,434

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009255679
Brazil	PI0913326
Canada	2723029
China	102056481
European Patent Office	2299810
Spain	2773931
Croatia	P20200450