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Details for Patent: 6,500,456

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Patent 6,500,456 protects NITROSTAT and is included in one NDA. There have been two Paragraph IV challenges on Nitrostat. There are three tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has thirteen patent family members in fifteen countries.

Summary for Patent: 6,500,456

Title: Compressed nitroglycerin tablet and its method of manufacture
Abstract:The present invention is directed to a stable nitroglycerin containing pharmaceutical composition, preferably a tablet which is prepared by direct compression technology. The formulation closely replicates the properties of nitroglycerin molded sublingual tablets (e.g. adequate disintegration and sublingual absorption), while reducing the problems experienced with compressed tablets (e.g. friability and weight variations). The stable tablets are characterized by a decreased migration of nitroglycerin, decreased potency loss, excellent content uniformity when stored. The preferred combination of components are: nitroglycerin/lactose dilution, hydrous lactose, glyceril monostearate, fumed silica, pregelantinized starch and calcium stearate. The preferred process employs direct compression technology to yield composition showing adequate disintegration, bioavailability and improved stability.
Inventor(s): Capella; Roberto L. (Landing, NJ)
Assignee: Warner-Lambert Company (Morris Plains, NJ)
Application Number:09/508,705
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Process;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 2nd percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Pfizer Pharms
TABLET;SUBLINGUAL021134-001May 1, 2000RXYesNo6,500,456► subscribe
Pfizer Pharms
TABLET;SUBLINGUAL021134-002May 1, 2000RXYesNo6,500,456► subscribe
Pfizer Pharms
TABLET;SUBLINGUAL021134-003May 1, 2000RXYesYes6,500,456► subscribe
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Foreign Priority and PCT Information for Patent: 6,500,456

PCT Information
PCT FiledSeptember 16, 1998PCT Application Number:PCT/US98/19356
PCT Publication Date:April 15, 1999PCT Publication Number: WO99/17766

International Patent Family for Patent: 6,500,456

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria209911► subscribe
Australia759018► subscribe
Australia9489398► 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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