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Details for Patent: 9,339,472

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Patent 9,339,472 protects KOMBIGLYZE XR and is included in one NDA. There has been one Paragraph IV challenge on Kombiglyze XR.

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

Summary for Patent: 9,339,472

Title:Coated tablet formulation and method
Abstract: A coated tablet formulation is provided which includes a medicament such as the DPP4-inhibitor, saxaglipitin ##STR00001## or its HCl salt, which is subject to intra-molecular cyclization, which formulation includes a tablet core containing one or more fillers, and other conventional excipients, which tablet core includes a coating thereon which may include two or more layers, at least one layer of which is an inner seal coat layer which is formed of one or more coating polymers, a second layer of which is formed of medicament which is the DPP4-inhibitor and one or more coating polymers, and an optional, but preferable third outer protective layer which is formed of one or more coating polymers. A method for forming the coated tablet is also provided.
Inventor(s): Desai; Divyakant S. (Princeton, NJ), Li; Bing V. (Princeton, NJ)
Assignee: AstraZeneca AB (Sodertalje, SE)
Application Number:14/150,331
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXNo9,339,472► subscribeY
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Non-Orange Book Patents for Patent: 9,339,472

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
8,628,799Coated tablet formulation and method► subscribe
7,951,400Coated tablet formulation and method► 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: 9,339,472

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
TaiwanI354569► subscribe
Slovenia1753406► subscribe
Russian Federation2372894► 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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