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Last Updated: October 20, 2020

DrugPatentWatch Database Preview

Metformin hydrochloride; repaglinide - Generic Drug Details

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What are the generic drug sources for metformin hydrochloride; repaglinide and what is the scope of patent protection?

Metformin hydrochloride; repaglinide is the generic ingredient in two branded drugs marketed by Novo Nordisk Inc and Lupin Ltd, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-nine drug master file entries for metformin hydrochloride; repaglinide.

Recent Clinical Trials for metformin hydrochloride; repaglinide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Hospital BirminghamPhase 4
University of LeicesterPhase 4
Emory UniversityPhase 4

See all metformin hydrochloride; repaglinide clinical trials

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; REPAGLINIDE
Tradename Dosage Ingredient NDA Submissiondate
PRANDIMET TABLET;ORAL metformin hydrochloride; repaglinide 022386 2009-04-09

US Patents and Regulatory Information for metformin hydrochloride; repaglinide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd REPAGLINIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; repaglinide TABLET;ORAL 200624-001 Jul 15, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008 DISCN Yes No   Start Trial   Start Trial   Start Trial
Lupin Ltd REPAGLINIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; repaglinide TABLET;ORAL 200624-002 Jul 15, 2015 DISCN No 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

Expired US Patents for metformin hydrochloride; repaglinide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008   Start Trial   Start Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008   Start Trial   Start Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008   Start Trial   Start Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
AstraZeneca
Colorcon
Dow
Mallinckrodt

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