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Details for Patent: 8,288,434

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Patent 8,288,434 protects ACANYA and ONEXTON and is included in one NDA. There have been zero Paragraph IV challenges on Onexton and Acanya

This patent has fourteen patent family members in ten 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): Chang; Yunik (Sonoma, CA), Dow; Gordon J. (Santa Rosa, CA)
Assignee: Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:12/455,525
Patent Claim Types:
see list of patent claims
Formulation; Use; Compound;
Patent Metrics:
Source: PatentQuant.com
Field: Basic materials chemistry
Back Citations: 6th percentile
Forward Citations: 2nd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Dow Pharm
ACANYA
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-001Oct 23, 2008RXYes8,288,434► subscribeY TREATMENT OF ACNE
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 2014RXYes8,288,434► subscribeY TOPICAL TREATMENT OF ACNE VULGARIS
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 2014RXYes8,288,434► subscribeY TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
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Non-Orange Book Patents for Patent: 8,288,434

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,895,070Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent► subscribe
9,078,870Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent► subscribe
8,663,699Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,288,434

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Russian Federation2013122395► subscribe
Russian Federation2493847► subscribe
Russian Federation2010146038► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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