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Last Updated: June 23, 2024

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 Msd Sub Merck and is included in two NDAs. There are two 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 sixty-one patent family members in forty countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Generic Entry Dates for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL
Generic Entry Dates for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

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

SponsorPhase
The Affiliated Hospital of Qingdao UniversityPhase 1
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Merck Sharp & Dohme Corp.

See all METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up1GM; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up500MG; 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 Strength NDA ANDAs Submitted Submissiondate
JANUMET XR Extended-release Tablets metformin hydrochloride; sitagliptin phosphate 100 mg/1000 mg 202270 1 2012-10-22
JANUMET XR Extended-release Tablets metformin hydrochloride; sitagliptin phosphate 50 mg/500 mg and 50 mg/1000 mg 202270 1 2012-03-16
JANUMET Tablets metformin hydrochloride; sitagliptin phosphate 50 mg/500 mg and 50 mg/1000 mg 022044 5 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
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  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 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 C300357 Netherlands ⤷  Sign Up 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
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
1506211 300677 Netherlands ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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