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Generated: May 22, 2019

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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
Prior Art and Litigation SupportOrder Prior Art and Litigation support 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 Submissiondate
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y EXPECTORANT ➤ Sign Up
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 OTC Yes No ➤ Sign Up ➤ Sign Up Y EXPECTORANT ➤ Sign Up
Rb Hlth 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
Rb Hlth 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
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No ➤ Sign Up ➤ Sign Up Y EXPECTORANT AND COUGH SUPPRESSANT ➤ Sign Up
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y EXPECTORANT AND COUGH SUPPRESSANT ➤ 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 Submissiondate

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International Family Members for US Patent 6,955,821

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 391494 ➤ Sign Up
Australia 2001255680 ➤ Sign Up
Australia 2003237807 ➤ Sign Up
Australia 5568001 ➤ Sign Up
Canada 2405031 ➤ Sign Up
Canada 2481739 ➤ Sign Up
Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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