PRANDIMET Drug Patent Profile

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.

Summary for PRANDIMET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	47
Formulation / Manufacturing:	see details
DailyMed Link:	PRANDIMET at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for PRANDIMET

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BX	Other blood glucose lowering drugs, excl. insulins
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008		DISCN	Yes	No

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	022386-002	Jun 23, 2008
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-001	Jun 23, 2008
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-001	Jun 23, 2008

International Patents for PRANDIMET

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

Country	Patent Number	Title	Estimated Expiration
Finland	845145
Canada	1292000	FORMES SOLIDES DE L'ACIDE 2-ETHOXY-4-[N-[1(2- PIPERIDINOPHENYL)-3-METHYL-1-BUTYL]- AMINOCARBONYLMETHYL]-BENZOIQUE (SOLID FORMS OF 2-ETHOXY-4-(N-(1-(2-PIPERIDINO- PHENYL)-3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZOIC ACID)
Norway	862631
Australia	5938386
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
Spain	8604547
Germany	69800806

Supplementary Protection Certificates for PRANDIMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211	PA2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2498758	16/2020	Austria		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113
0147850	99C0002	Belgium		PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817
1532149	132013902118390	Italy		PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1506211	122014000071	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116