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Serving leading biopharmaceutical companies globally:

Colorcon
Healthtrust
Novartis
Argus Health
Harvard Business School
Julphar
McKesson
Daiichi Sankyo
Teva
Citi

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for Patent: 7,838,032

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Summary for Patent: 7,838,032
Title:Sustained release of guaifenesin
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 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. 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: Reckitt Benckiser Inc. (Parsippany, NJ)
Application Number:10/406,557
Patent Claim Types:
see list of patent claims
Compound; Dosage form;

Drugs Protected by US Patent 7,838,032

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Reckitt Benckiser MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 OTC Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 OTC Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 7,838,032

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
6,372,252 Guaifenesin sustained release formulation and tablets ➤ Subscribe
8,012,504 Sustained release of guaifenesin combination drugs ➤ Subscribe
6,955,821 Sustained release formulations of guaifenesin and additional drug ingredients ➤ Subscribe
7,985,420 Sustained release of guaifenesin combination drugs ➤ Subscribe
7,985,421 Sustained release formulations of guaifenesin and additional drug ingredients ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 7,838,032

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Taiwan 200400836 ➤ Subscribe
Portugal 1276467 ➤ Subscribe
New Zealand 561044 ➤ Subscribe
New Zealand 562286 ➤ Subscribe
Japan 2003531849 ➤ Subscribe
Japan 5466346 ➤ Subscribe
Israel 190742 ➤ Subscribe
Japan 2005528402 ➤ Subscribe
Israel 164438 ➤ Subscribe
Israel 152012 ➤ Subscribe
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Federal Trade Commission
Cipla
Baxter
Deloitte
Daiichi Sankyo
Boehringer Ingelheim
Healthtrust
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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