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Last Updated: March 28, 2024

Saxagliptin hydrochloride - Generic Drug Details


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

Saxagliptin hydrochloride is the generic ingredient in two branded drugs marketed by Astrazeneca Ab, Amneal, Aurobindo Pharma, Glenmark Pharms Ltd, Mylan, and Sun Pharm, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Saxagliptin hydrochloride has fifty-seven patent family members in thirty-two countries.

There are eight drug master file entries for saxagliptin hydrochloride. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for saxagliptin hydrochloride

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

SponsorPhase
University of Erlangen-Nürnberg Medical SchoolPhase 4
Ain Shams UniversityN/A
Sabyasachi SenPhase 3

See all saxagliptin hydrochloride clinical trials

Generic filers with tentative approvals for SAXAGLIPTIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 5MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 2.5MG BASETABLET;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 saxagliptin hydrochloride
Paragraph IV (Patent) Challenges for SAXAGLIPTIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ONGLYZA Tablets saxagliptin hydrochloride 2.5 mg and 5 mg 022350 8 2013-07-31

US Patents and Regulatory Information for saxagliptin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205972-002 Jul 31, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205941-001 Jul 31, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Aurobindo Pharma SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205972-001 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 saxagliptin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for saxagliptin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498758 132020000000034 Italy ⤷  Try a Trial PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
2498758 2020C/509 Belgium ⤷  Try a Trial PRODUCT NAME: QTRILMET - 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
2139494 LUC00176 Luxembourg ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
1261586 132012902044560 Italy ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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