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Details for Patent: 8,323,692

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Patent 8,323,692 protects GLUMETZA and is included in one NDA. There has been one Paragraph IV challenge on Glumetza.

This patent has twenty-two patent family members in fourteen countries.

Summary for Patent: 8,323,692

Title:Controlled release dosage forms
Abstract: The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55.degree. C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.
Inventor(s): Frisbee; Steven (Reston, VA)
Assignee: Valeant International Bermuda (Hamilton, BM)
Application Number:12/328,828
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Process;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 29th 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
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005RXYes8,323,692► subscribeY
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Non-Orange Book Patents for Patent: 8,323,692

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
8,158,147Modified release formulations of at least one form of tramadol► subscribe
2,005,182,056► subscribe
7,780,987Controlled release dosage forms► 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: 8,323,692

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria536173► subscribe
Australia2003211145► subscribe
Australia2003211146► 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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