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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Medtronic
Moodys
Baxter
UBS
Federal Trade Commission
McKinsey
Julphar
Covington

Generated: July 15, 2018

DrugPatentWatch Database Preview

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 guaifenesin; hydrocodone bitartrate freedom to operate?

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 is one patent 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. Two suppliers are listed for this compound.
Summary for guaifenesin; hydrocodone bitartrate
US Patents:1
Tradenames:4
Applicants:3
NDAs:4
Drug Master File Entries: 20
Suppliers / Packagers: 2
DailyMed Link:guaifenesin; hydrocodone bitartrate at DailyMed
Pharmacology for guaifenesin; hydrocodone bitartrate
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists

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
Bkk Pharms HYCOFENIX guaifenesin; hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 022279-001 May 14, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sovereign Pharms OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474-001 Nov 14, 2014 DISCN Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Eci Pharms Llc HYDROCODONE BITARTRATE AND GUAIFENESIN guaifenesin; hydrocodone bitartrate TABLET;ORAL 208085-001 Apr 25, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bkk Pharms FLOWTUSS guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 022424-001 May 14, 2015 RX No No ➤ Sign Up ➤ Sign Up ➤ 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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Non-Orange Book US Patents for guaifenesin; hydrocodone bitartrate

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
9,808,431 Immediate release oral guaifenesin solution ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Mallinckrodt
Citi
Healthtrust
McKesson
Chinese Patent Office
Federal Trade Commission
Harvard Business School
Cipla

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.