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PRANDIN Drug Profile

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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. Nine suppliers are listed for this compound. Additional details are available on the repaglinide profile page.

US ANDA 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
Bulk Api Vendors:	104
Patent Applications:	4,053
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PRANDIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRANDIN
What excipients (inactive ingredients) are in PRANDIN?	PRANDIN excipients list
DailyMed Link:	PRANDIN at DailyMed

See drug prices for PRANDIN

Paragraph IV (Patent) Challenges for PRANDIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
PRANDIN	TABLET;ORAL	repaglinide	020741	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	020741-003	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	020741-003	Dec 22, 1997

International Patents for PRANDIN

Country	Patent Number	Estimated Expiration
Spain	2159184
Spain	8605500
Portugal	82832
Israel	73963
Luxembourg	90301
Greece	861558

Supplementary Protection Certificates for PRANDIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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/
0147850	99C0002	Belgium		PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817