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Last Updated: March 19, 2024

Metformin hydrochloride; saxagliptin hydrochloride - Generic Drug Details


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

Metformin hydrochloride; saxagliptin hydrochloride is the generic ingredient in three branded drugs marketed by Astrazeneca Ab, Dr Reddys Labs Sa, Mylan, and Sun Pharm, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; saxagliptin hydrochloride has fifty-seven patent family members in thirty-two countries.

Three suppliers are listed for this compound.

Recent Clinical Trials for metformin hydrochloride; saxagliptin hydrochloride

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

SponsorPhase
Sabyasachi SenPhase 4
Dongguan Kanghua HospitalPhase 4
Third Affiliated Hospital, Sun Yat-Sen UniversityPhase 4

See all metformin hydrochloride; saxagliptin hydrochloride clinical trials

Pharmacology for metformin hydrochloride; saxagliptin hydrochloride
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KOMBIGLYZE XR Extended-release Tablets metformin hydrochloride; saxagliptin hydrochloride 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg 200678 3 2013-07-31

US Patents and Regulatory Information for metformin hydrochloride; saxagliptin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205981-002 Jul 31, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 207678-003 Aug 9, 2023 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 207678-002 Aug 9, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205981-003 Jul 31, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205981-001 Jul 31, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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; saxagliptin hydrochloride

International Patents for metformin hydrochloride; saxagliptin hydrochloride

Country Patent Number Title Estimated Expiration
Portugal 2298288 ⤷  Try a Trial
Hungary E029446 ⤷  Try a Trial
Lithuania 2298288 ⤷  Try a Trial
China 102895208 Coated tablet formulation and method ⤷  Try a Trial
Canada 2568391 FORMULATION DE COMPRIME REVETU ET PROCEDE CORRESPONDANT (COATED TABLET FORMULATION AND METHOD) ⤷  Try a Trial
Taiwan 200609002 Coated tablet formulation and method ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for metformin hydrochloride; saxagliptin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498758 301040 Netherlands ⤷  Try a Trial PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
1506211 300677 Netherlands ⤷  Try a 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
2498758 2090013-0 Sweden ⤷  Try a Trial 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
1532149 PA2012022 Lithuania ⤷  Try a Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149 C300569 Netherlands ⤷  Try a 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
1261586 12C0028 France ⤷  Try a Trial PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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