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	022386-002	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	022386-001	Jun 23, 2008

International Patents for PRANDIMET

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

Country	Patent Number	Title	Estimated Expiration
Spain	545883
Spain	8604548
Bulgaria	61519
Ireland	861752
Finland	83417
European Patent Office	0147850	PHENYLACETIC-ACID DERIVATIVES, MEDICINES CONTAINING THESE COMPOUNDS AND PROCESS FOR THEIR PREPARATION
New Zealand	210657	PHENYLACETIC ACID DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS

Supplementary Protection Certificates for PRANDIMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	122020000018	Germany		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1412357	50/2008	Austria		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
2498758	2090013-0	Sweden		PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
1412357	132008901682802	Italy		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
2498758	CA 2020 00017	Denmark		PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
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
0861666	07C0006	France		PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728