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Serving leading biopharmaceutical companies globally:

Express Scripts
QuintilesIMS
Farmers Insurance
Novartis
Boehringer Ingelheim
Mallinckrodt
Federal Trade Commission
McKinsey
Cipla
US Army

Generated: January 20, 2018

DrugPatentWatch Database Preview

Guaifenesin; pseudoephedrine hydrochloride - Generic Drug Details

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What are the generic sources for guaifenesin; pseudoephedrine hydrochloride and what is the scope of guaifenesin; pseudoephedrine hydrochloride patent protection?

Guaifenesin; pseudoephedrine hydrochloride
is the generic ingredient in two branded drugs marketed by Actavis Labs Fl and Reckitt Benckiser, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Guaifenesin; pseudoephedrine hydrochloride has thirty-nine patent family members in nineteen countries.

There are twenty drug master file entries for guaifenesin; pseudoephedrine hydrochloride. Twenty-one suppliers are listed for this compound.
Summary for guaifenesin; pseudoephedrine hydrochloride
Pharmacology for guaifenesin; pseudoephedrine hydrochloride

US Patents and Regulatory Information for guaifenesin; pseudoephedrine hydrochloride

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 021585-001 Jun 22, 2004 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
Actavis Labs Fl GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071-002 May 27, 2015 OTC No No ➤ Subscribe ➤ Subscribe ➤ 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 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 021585-002 Jun 22, 2004 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Actavis Labs Fl GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071-001 May 27, 2015 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Non-Orange Book US Patents for guaifenesin; pseudoephedrine hydrochloride

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

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International Patents for guaifenesin; pseudoephedrine hydrochloride

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Cipla
Citi
Mallinckrodt
Covington
Johnson and Johnson
Colorcon
US Department of Justice

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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