PRANDIN Drug Patent Profile

When do Prandin patents expire, and what generic alternatives are available?

Prandin is a drug marketed by Gemini Labs Llc and is included in one NDA.

The generic ingredient in PRANDIN is repaglinide. There are sixteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the repaglinide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prandin

A generic version of PRANDIN was approved as repaglinide by SUN PHARM INDS INC on July 11^th, 2013.

Summary for PRANDIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	3
Patent Applications:	4,297
Drug Prices:	Drug price information for PRANDIN
What excipients (inactive ingredients) are in PRANDIN?	PRANDIN excipients list
DailyMed Link:	PRANDIN at DailyMed

See drug prices for PRANDIN

Recent Clinical Trials for PRANDIN

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

Sponsor	Phase
Pfizer	Phase 1
University of Leicester	Phase 4
University Hospital Birmingham	Phase 4

See all PRANDIN clinical trials

Paragraph IV (Patent) Challenges for PRANDIN

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 PRANDIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gemini Labs Llc	PRANDIN	repaglinide	TABLET;ORAL	020741-001	Dec 22, 1997		DISCN	Yes	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

Expired US Patents for PRANDIN

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

EU/EMA Drug Approvals for PRANDIN

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

International Patents for PRANDIN

See the table below for patents covering PRANDIN around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	539078
Spain	545882
European Patent Office	0207331	SOLID FORMS OF 2-ETHOXY-4-ÛN-(1-(2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINO-CARBONYLMETHYL ̈-BENZOIC ACID, MEDICAMENTS CONTAINING THESE FORMS AND PROCESS FOR THEIR PREPARATION
Finland	862650
South Africa	8410103
Australia	3721084
New Zealand	208416	ORALLY ADMINISTRABLE COMPOSITIONS HAVING IMPROVED RELEASE OF ANTI-DIABETIC SUBSTANCES

Supplementary Protection Certificates for PRANDIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0147850	99C0002	Belgium		PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817
0147850	SPC/GB98/042	United Kingdom		PRODUCT NAME: 2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZOIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT AND/OR OPTIONALLY IN THE FORM OF AN ENANTIOMER, IN PARTICULAR (S)(+)-2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3; REGISTERED: UK EU/1/98/076/001 19980817; UK EU/1/98/076/002 19980817; UK EU/1/98/076/003 19980817; UK EU/1/98/076/004 19980817; UK EU/1/98/076/005 19980817; UK EU/1/98/076/006 19980817; UK EU/1/98/076/019 19980817; UK EU/1/98/076/020 19980817; UK EU/1/98/076/021 19980817; UK EU/1/98/076/013 19980817; UK EU/1/98/076/014 19980817; UK EU/1/98/076/015 19980817; UK EU/1/98/076/016 19980817; UK EU/1/98/076/017 19980817; UK EU/1/98/