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.

Summary for METFORMIN HYDROCHLORIDE; REPAGLINIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Clinical Trials:	22
DailyMed Link:	METFORMIN HYDROCHLORIDE; REPAGLINIDE at DailyMed

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; REPAGLINIDE

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 1
Medicines for Malaria Venture	Phase 1
AstraZeneca	Phase 2/Phase 3

See all METFORMIN HYDROCHLORIDE; REPAGLINIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for METFORMIN HYDROCHLORIDE; REPAGLINIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BX	Other blood glucose lowering drugs, excl. insulins
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

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Glossary

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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	022386-002	Jun 23, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; repaglinide	TABLET;ORAL	200624-001	Jul 15, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; repaglinide	TABLET;ORAL	200624-002	Jul 15, 2015		DISCN	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

Expired US Patents for METFORMIN HYDROCHLORIDE; REPAGLINIDE

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

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