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Last Updated: February 23, 2020

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GUAIFENESIN; HYDROCODONE BITARTRATE - Generic Drug Details

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

Guaifenesin; hydrocodone bitartrate is the generic ingredient in four branded drugs marketed by Bkk Pharms, Sovereign Pharms, and Eci Pharms Llc, and is included in four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for guaifenesin; hydrocodone bitartrate.

Summary for GUAIFENESIN; HYDROCODONE BITARTRATE
US Patents:3
Tradenames:4
Applicants:3
NDAs:4
Drug Master File Entries: 20
Clinical Trials: 1
DailyMed Link:GUAIFENESIN; HYDROCODONE BITARTRATE at DailyMed
Recent Clinical Trials for GUAIFENESIN; HYDROCODONE BITARTRATE

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SponsorPhase
Reckitt Benckiser LLCPhase 1

See all GUAIFENESIN; HYDROCODONE BITARTRATE clinical trials

US Patents and Regulatory Information for GUAIFENESIN; HYDROCODONE BITARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eci Pharms Llc XTRELUS guaifenesin; hydrocodone bitartrate TABLET;ORAL 208085-001 Apr 25, 2018 DISCN Yes No   Start Trial   Start Trial   Start Trial
Sovereign Pharms OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474-001 Nov 14, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Bkk Pharms FLOWTUSS guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 022424-001 May 14, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Sovereign Pharms OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474-001 Nov 14, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Bkk Pharms HYCOFENIX guaifenesin; hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 022279-001 May 14, 2015 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Merck
McKesson
Dow
Medtronic

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