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Generated: September 23, 2018

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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.

The generic ingredient in MUCINEX D is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

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
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 021585-002 Jun 22, 2004 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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 ➤ 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

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Merck
Boehringer Ingelheim
Argus Health
Medtronic
Cerilliant
Accenture
Julphar
Chinese Patent Office

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