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Details for Patent: 6,372,252

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Patent 6,372,252 protects MUCINEX DM, MUCINEX, and MUCINEX D, and is included in three NDAs. There have been zero Paragraph IV challenges on Mucinex DM and Mucinex

This patent has thirty-four patent family members in nineteen countries.

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;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 55th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCNo6,372,252► subscribeY
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-001Apr 29, 2004OTCYes6,372,252► subscribeY
Reckitt Benckiser
MUCINEX
guaifenesin
TABLET, EXTENDED RELEASE;ORAL021282-002Dec 18, 2002OTCYes6,372,252► subscribe EXPECTORANT
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Non-Orange Book Patents 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
8,012,504Sustained release of guaifenesin combination drugs► subscribe
6,955,821 Sustained release formulations of guaifenesin and additional drug ingredients► subscribe
7,838,032Sustained release of guaifenesin► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 6,372,252

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria391494► subscribe
Australia2001255680► subscribe
Australia2003237807► 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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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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