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Last Updated: November 24, 2024

PRANDIMET Drug Patent Profile


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Which patents cover Prandimet, and when can generic versions of Prandimet launch?

Prandimet is a drug marketed by Novo Nordisk Inc and is included in one NDA.

The generic ingredient in PRANDIMET is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.

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Summary for PRANDIMET
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 2
Patent Applications: 38
DailyMed Link:PRANDIMET at DailyMed
Drug patent expirations by year for PRANDIMET
Paragraph IV (Patent) Challenges for PRANDIMET
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PRANDIMET Tablets metformin hydrochloride; repaglinide 1 mg/500 mg and 2 mg/500 mg 022386 1 2009-04-09

US Patents and Regulatory Information for PRANDIMET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 PRANDIMET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-002 Jun 23, 2008 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PRANDIMET

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

Country Patent Number Title Estimated Expiration
Japan S625974 NOVEL PHENYLACETATE DERIVATIVE, PHARMACEUTICAL COMPOSITION AND PRODUCTION THEREOF ⤷  Sign Up
New Zealand 216640 SOLID FORMS OF 2-ETHOXY-4-(N-(1-(2-PIPERIDINO-PHENYL) -3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZOIC ACID ⤷  Sign Up
Norway 167736 ⤷  Sign Up
New Zealand 216700 PHENYLACETIC ACID DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRANDIMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 C01506211/02 Switzerland ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1532149 92128 Luxembourg ⤷  Sign Up PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
1261586 12C0028 France ⤷  Sign Up PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1412357 132008901682802 Italy ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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