REPAGLINIDE Drug Patent Profile

When do Repaglinide patents expire, and when can generic versions of Repaglinide launch?

Repaglinide is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Mylan, Padagis Us, Sun Pharm Inds Inc, and Lupin Ltd. and is included in nine NDAs.

The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.

Summary for REPAGLINIDE

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	61
Patent Applications:	4,043
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for REPAGLINIDE
DailyMed Link:	REPAGLINIDE at DailyMed

See drug prices for REPAGLINIDE

Recent Clinical Trials for REPAGLINIDE

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

Sponsor	Phase
Eli Lilly and Company	Phase 1
Atriva Therapeutics GmbH	Phase 1
Medicines for Malaria Venture	Phase 1

See all REPAGLINIDE clinical trials

Pharmacology for REPAGLINIDE

Drug Class	Glinide
Mechanism of Action	Potassium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for REPAGLINIDE

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 REPAGLINIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRANDIN	Tablets	repaglinide	0.5 mg*, 1 mg and 2 mg	020741	1	2005-02-10

US Patents and Regulatory Information for REPAGLINIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Totowa	REPAGLINIDE	repaglinide	TABLET;ORAL	090008-001	Jan 22, 2014		DISCN	No	No
Mylan	REPAGLINIDE	repaglinide	TABLET;ORAL	090252-003	Jan 22, 2014		DISCN	No	No
Lupin Ltd	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; repaglinide	TABLET;ORAL	200624-001	Jul 15, 2015		DISCN	No	No
Chartwell Rx	REPAGLINIDE	repaglinide	TABLET;ORAL	078555-001	Nov 22, 2013	AB	RX	No	No
Aurobindo Pharma Ltd	REPAGLINIDE	repaglinide	TABLET;ORAL	203820-001	Jan 22, 2014	AB	RX	No	No
Kenton	REPAGLINIDE	repaglinide	TABLET;ORAL	091517-003	Apr 24, 2015		DISCN	No	No

EU/EMA Drug Approvals for REPAGLINIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Repaglinide Accord	repaglinide	EMEA/H/C/002318 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	yes	no	no	2011-12-22
Teva Pharma B.V.	Repaglinide Teva	repaglinide	EMEA/H/C/001067 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	yes	no	no	2009-06-28
Krka, d.d., Novo mesto	Repaglinide Krka	repaglinide	EMEA/H/C/001066 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	yes	no	no	2009-11-03
Krka, d.d., Novo mesto	Enyglid	repaglinide	EMEA/H/C/001065 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	yes	no	no	2009-10-13
Novo Nordisk A/S	Prandin	repaglinide	EMEA/H/C/000362 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	no	no	no	2001-01-29
Novo Nordisk A/S	NovoNorm	repaglinide	EMEA/H/C/000187 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.	Authorised	no	no	no	1998-08-16