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Last Updated: March 28, 2024

PRANDIN Drug Patent 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. 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 11th, 2013.

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Summary for PRANDIN
Drug patent expirations by year for PRANDIN
Drug Prices for PRANDIN

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Recent Clinical Trials for PRANDIN

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

SponsorPhase
University of LeicesterPhase 4
University Hospital BirminghamPhase 4
National Institutes of Health (NIH)N/A

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for PRANDIN

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

Country Patent Number Title Estimated Expiration
Spain 8604548 ⤷  Try a Trial
European Patent Office 1097710 Produit de combinaison pour le traitement du diabète sucré non-insulinodependant (NIDDM) (Combination product for treating niddm) ⤷  Try a Trial
Denmark 1011673 ⤷  Try a Trial
Spain 2003629 PROCEDIMIENTO PARA PREPARAR NUEVOS DERIVADOS DE ACIDOS FENILACETICOS (Phenylacetic-acid derivatives, pharmaceutical compositions containing them and processes for their production.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRANDIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0147850 99C0002 Belgium ⤷  Try a Trial PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817
0147850 SPC/GB98/042 United Kingdom ⤷  Try a 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/
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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