➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Colorcon
Mallinckrodt
AstraZeneca
Dow

Last Updated: August 11, 2020

DrugPatentWatch Database Preview

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic sources for metformin hydrochloride; pioglitazone hydrochloride and what is the scope of patent protection?

Metformin hydrochloride; pioglitazone hydrochloride is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan, Sandoz, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in eight NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; pioglitazone hydrochloride has one hundred and twenty-seven patent family members in thirty-one countries.

There are forty-nine drug master file entries for metformin hydrochloride; pioglitazone hydrochloride. Six suppliers are listed for this compound.

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

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

SponsorPhase
All India Institute of Medical Sciences, BhubaneswarPhase 4
Azienda Ospedaliero-Universitaria di ParmaPhase 2/Phase 3
Chiayi Christian HospitalPhase 2

See all METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE clinical trials

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ACTOPLUS MET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; pioglitazone hydrochloride 022024 2011-09-23

US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Torrent Pharms Ltd PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 202001-001 Feb 13, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 091273-001 Apr 16, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-002 Aug 29, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-001 Aug 29, 2005 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 DISCN Yes No   Start Trial   Start Trial Y   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 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 C300677 Netherlands   Start Trial 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
1532149 C300569 Netherlands   Start Trial PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1412357 122008000046 Germany   Start Trial PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1532149 132013902118390 Italy   Start Trial 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
2498758 LUC00152 Luxembourg   Start Trial PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1506211 PA2014026,C1506211 Lithuania   Start Trial PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211 SPC/GB14/050 United Kingdom   Start Trial PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Johnson and Johnson
McKesson
McKinsey
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.