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Last Updated: April 14, 2021

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Metformin hydrochloride; sitagliptin phosphate - Generic Drug Details

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What are the generic drug sources for metformin hydrochloride; sitagliptin phosphate and what is the scope of freedom to operate?

Metformin hydrochloride; sitagliptin phosphate is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme and is included in two NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; sitagliptin phosphate has one hundred and thirty-six patent family members in forty-six countries.

There are forty-nine drug master file entries for metformin hydrochloride; sitagliptin phosphate. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for metformin hydrochloride; sitagliptin phosphate

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

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Merck Sharp & Dohme Corp.N/A
University of NebraskaN/A

See all metformin hydrochloride; sitagliptin phosphate clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial1GM; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial500MG; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for metformin hydrochloride; sitagliptin phosphate
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Tradename Dosage Ingredient NDA Submissiondate
JANUMET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; sitagliptin phosphate 202270 2012-10-22
JANUMET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; sitagliptin phosphate 202270 2012-03-16
JANUMET TABLET;ORAL metformin hydrochloride; sitagliptin phosphate 022044 2010-10-18

US Patents and Regulatory Information for metformin hydrochloride; sitagliptin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 RX Yes No   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes   Start Trial   Start Trial   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; sitagliptin phosphate

International Patents for metformin hydrochloride; sitagliptin phosphate

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2005003135   Start Trial
Norway 321999   Start Trial
Malaysia 139595   Start Trial
Serbia 20050947   Start Trial
World Intellectual Property Organization (WIPO) 2007078726   Start Trial
Norway 2020007   Start Trial
Iceland 8617   Start Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for metformin hydrochloride; sitagliptin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/02 Switzerland   Start Trial PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1412357 C300357 Netherlands   Start Trial PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357 0790041-8 Sweden   Start Trial PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT
1412357 91470 Luxembourg   Start Trial 91470, EXPIRES: 20280818
1412357 SPC/GB08/040 United Kingdom   Start Trial PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
1412357 106 4-2007 Slovakia   Start Trial PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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