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Last Updated: March 6, 2021

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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 11th, 2013.

  Start Trial

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

Supplementary Protection Certificates for PRANDIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0147850 SPC/GB98/042 United Kingdom   Start Trial 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   Start Trial PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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