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Last Updated: November 28, 2024

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Saxagliptin - Generic Drug Details


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Recent Clinical Trials for saxagliptin

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 clinical trials

Generic filers with tentative approvals for SAXAGLIPTIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5MG;1000MGTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up2.5MG;1000MGTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up5MG;500MGTABLET, 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.

US Patents and Regulatory Information for saxagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sun Pharm SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 206078-002 Jul 31, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205980-001 Jul 31, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 206078-001 Jul 31, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205941-001 Jul 31, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205994-001 Jul 31, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205941-002 Jul 31, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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.