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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Farmers Insurance
McKesson
Johnson and Johnson
Harvard Business School
Argus Health
Daiichi Sankyo
US Army
Boehringer Ingelheim

Generated: July 17, 2018

DrugPatentWatch Database Preview

MUCINEX D Drug Profile

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When do Mucinex D patents expire, and when can generic versions of Mucinex D launch?

Mucinex D is a drug marketed by Reckitt Benckiser and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-nine patent family members in nineteen countries.

The generic ingredient in MUCINEX D is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Drug patent expirations by year for MUCINEX D
Generic Entry Opportunity Date for MUCINEX D
Generic Entry Date for MUCINEX D*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for MUCINEX D

US Patents and Regulatory Information for MUCINEX D

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No ➤ Sign Up ➤ Sign Up Y ➤ 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 ➤ Sign Up
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for MUCINEX D
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 600 mg/30 mg and 1200 mg/60 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for MUCINEX D

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
8,012,504 Sustained release of guaifenesin combination drugs ➤ Sign Up
7,985,421 Sustained release formulations of guaifenesin and additional drug ingredients ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Johnson and Johnson
Chubb
Argus Health
Harvard Business School
Fuji
Daiichi Sankyo
Medtronic
Covington

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.