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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Novartis
Boehringer Ingelheim
US Army
McKinsey
AstraZeneca
UBS
Cantor Fitzgerald
Teva
Fuji

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for Patent: 6,372,252

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Summary for Patent: 6,372,252
Title: Guaifenesin sustained release formulation and tablets
Abstract:The invention relates to a novel pharmaceutical sustained release formulation of guaifenesin. The formulation may comprise a hydrophilic polymer, preferably a hydroxypropyl methylcellulose, and a water-insoluble polymer, preferably an acrylic resin, in a ratio range of about one-to-one (1:1) to about six-to-one (6:1), more preferably a range of about three-to-two (3:2) to about four-to-one (4:1), and most preferably about two-to-one (2:1), by weight. This formulation capable of providing therapeutically effective bioavailability of guaifenesin for at least twelve hours after dosing in a human subject. The invention also relates to a modified release guaifenesin tablet which has two portion: the first portion comprises an immediate release formulation of guaifenesin and the second portion comprises a sustained release formulation of guaifenesin as described above. This two portion, or bi-layer, tablet has a maximum serum concentration equivalent to that of an immediate release guaifenesin tablet, and is capable of providing therapeutically effective bioavailability of guaifenesin for at least twelve hours after dosing in a human subject.
Inventor(s): Blume; Ralph W. (Fort Worth, TX), Davis; Robert D. (Arlington, TX), Keyser; Donald Jeffrey (Southlake, TX)
Assignee: Adams Laboratories, Inc. (Ft. Worth, TX)
Application Number:09/559,542
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;

Drugs Protected by US Patent 6,372,252

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Reckitt Benckiser MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial EXPECTORANT ➤ Try a Free Trial
Reckitt Benckiser MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial EXPECTORANT ➤ Try a Free Trial
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 6,372,252

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
6,955,821 Sustained release formulations of guaifenesin and additional drug ingredients ➤ Try a Free Trial
7,985,421 Sustained release formulations of guaifenesin and additional drug ingredients ➤ Try a Free Trial
8,012,504 Sustained release of guaifenesin combination drugs ➤ Try a Free Trial
7,838,032 Sustained release of guaifenesin ➤ Try a Free Trial
7,985,420 Sustained release of guaifenesin combination drugs ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 6,372,252

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 391494 ➤ Try a Free Trial
Australia 2001255680 ➤ Try a Free Trial
Australia 2003237807 ➤ Try a Free Trial
Australia 5568001 ➤ Try a Free Trial
Canada 2405031 ➤ Try a Free Trial
Canada 2481739 ➤ Try a Free Trial
China 1655766 ➤ Try a Free Trial
Cyprus 1108166 ➤ Try a Free Trial
Germany 60133538 ➤ Try a Free Trial
Denmark 1276467 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
AstraZeneca
Merck
Fuji
Healthtrust
McKesson
Medtronic
Citi
Daiichi Sankyo

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