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Last Updated: July 28, 2021

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Dextromethorphan hydrobromide; guaifenesin - Generic Drug Details

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What are the generic drug sources for dextromethorphan hydrobromide; guaifenesin and what is the scope of patent protection?

Dextromethorphan hydrobromide; guaifenesin is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma Ltd, Perrigo R And D, and Rb Hlth, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for dextromethorphan hydrobromide; guaifenesin. Fifty-three suppliers are listed for this compound.

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Tradename Dosage Ingredient NDA Submissiondate
MUCINEX DM TABLET, EXTENDED RELEASE;ORAL dextromethorphan hydrobromide; guaifenesin 021620 2008-12-17

US Patents and Regulatory Information for dextromethorphan hydrobromide; guaifenesin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 209692-002 Nov 1, 2018 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Aurobindo Pharma Ltd GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 206941-002 Mar 17, 2017 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Actavis Labs Fl GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 091070-001 Aug 31, 2015 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amneal Pharms GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 209692-001 Nov 1, 2018 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Perrigo R And D GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 207602-002 Mar 5, 2018 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Aurobindo Pharma Ltd GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 206941-001 Mar 17, 2017 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for dextromethorphan hydrobromide; guaifenesin

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Johnson and Johnson
Merck
McKesson
Dow

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