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Last Updated: March 29, 2024

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 freedom to operate?

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.

Summary for metformin hydrochloride; repaglinide
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Clinical Trials: 21
DailyMed Link:metformin hydrochloride; repaglinide at DailyMed
Recent Clinical Trials for metformin hydrochloride; repaglinide

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

SponsorPhase
Medicines for Malaria VenturePhase 1
Novartis PharmaceuticalsPhase 1
Ministry of Health, KuwaitPhase 4

See all metformin hydrochloride; repaglinide clinical trials

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; REPAGLINIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PRANDIMET Tablets metformin hydrochloride; repaglinide 1 mg/500 mg and 2 mg/500 mg 022386 1 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
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd REPAGLINIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; repaglinide TABLET;ORAL 200624-002 Jul 15, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd REPAGLINIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; repaglinide TABLET;ORAL 200624-001 Jul 15, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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