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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Accenture
Chinese Patent Office
Daiichi Sankyo
Fuji
AstraZeneca
Citi
Medtronic

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for Patent: 6,955,821

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Summary for Patent: 6,955,821
Title: Sustained release formulations of guaifenesin and additional drug ingredients
Abstract:The invention relates to a novel pharmaceutical sustained release formulation of guaifenesin and at least one additional drug ingredient. 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 nine-to-one (9:1), more preferably a range of about three-to-two (3:2) to about six-to-one (6:1), and most preferably in a range of about two-to-one (2:1) to about four-to-one (4:1) 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 product which has two portions: a first portion having an immediate release formulation of guaifenesin and a second portion having a sustained release formulation of guaifenesin, wherein one or both portions has at least one additional drug ingredient. The modified release product has a maximum guaifenesin 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): Davis; Robert D. (Arlington, TX), Blume; Ralph W. (Fort Worth, TX), Keyser; Donald Jeffrey (Southlake, TX)
Assignee: Adams Laboratories, Inc. (Fort Worth, TX)
Application Number:10/121,706
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,955,821
Patent Claim Types:
see list of patent claims
Formulation; Compound; Composition; Dosage form; Use; Delivery;

Drugs Protected by US Patent 6,955,821

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 ➤ Sign Up ➤ Sign Up Y EXPECTORANT ➤ Sign Up
Reckitt Benckiser MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 OTC Yes No ➤ Sign Up ➤ Sign Up Y EXPECTORANT ➤ Sign Up
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y EXPECTORANT AND NASAL DECONGESTANT ➤ Sign Up
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 OTC Yes No ➤ Sign Up ➤ Sign Up Y EXPECTORANT AND NASAL DECONGESTANT ➤ Sign Up
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 6,955,821

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
7,985,420 Sustained release of guaifenesin combination drugs ➤ Sign Up
6,372,252 Guaifenesin sustained release formulation and tablets ➤ Sign Up
7,985,421 Sustained release formulations of guaifenesin and additional drug ingredients ➤ Sign Up
7,838,032 Sustained release of guaifenesin ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Cipla
AstraZeneca
Fuji
Deloitte
Chubb
Chinese Patent Office
QuintilesIMS
US Department of Justice

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