REPAGLINIDE - Generic Drug Details

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

Repaglinide is the generic ingredient in two branded drugs marketed by Gemini Labs Llc, Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Norvium Bioscience, Padagis Us, and Sun Pharm Inds Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for repaglinide. Seven suppliers are listed for this compound.

Summary for REPAGLINIDE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	66
Patent Applications:	7,298
Drug Prices:	Drug price trends for REPAGLINIDE
What excipients (inactive ingredients) are in REPAGLINIDE?	REPAGLINIDE excipients list
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
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company	Phase 1
Pfizer	Phase 1
Eli Lilly and Company	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
Sun Pharm Inds Inc	REPAGLINIDE	repaglinide	TABLET;ORAL	077571-002	Jul 11, 2013	AB	RX	No	No
Padagis Us	REPAGLINIDE	repaglinide	TABLET;ORAL	201189-001	Jul 17, 2013	AB	RX	No	No
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997		DISCN	Yes	No
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997		DISCN	Yes	No
Kenton	REPAGLINIDE	repaglinide	TABLET;ORAL	091517-002	Apr 24, 2015		DISCN	No	No
Actavis Totowa	REPAGLINIDE	repaglinide	TABLET;ORAL	090008-003	Jan 22, 2014		DISCN	No	No
Actavis Totowa	REPAGLINIDE	repaglinide	TABLET;ORAL	090008-001	Jan 22, 2014		DISCN	No	No

Expired US Patents for REPAGLINIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-002	Dec 22, 1997
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-003	Dec 22, 1997
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997

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