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Last Updated: January 28, 2021

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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 one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Saxagliptin hydrochloride has one hundred and twenty-six patent family members in forty countries.

There are fifteen drug master file entries for saxagliptin hydrochloride. Two 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
Ain Shams UniversityN/A
Sabyasachi SenPhase 3
Beni-Suef UniversityPhase 4

See all saxagliptin hydrochloride clinical trials

Generic filers with tentative approvals for SAXAGLIPTIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MG/5MGTABLET; 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 NDA Submissiondate
ONGLYZA TABLET;ORAL saxagliptin hydrochloride 022350 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
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No   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

Supplementary Protection Certificates for saxagliptin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 C01261586/02 Switzerland   Start Trial PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
1261586 C300436 Netherlands   Start Trial PRODUCT NAME: SAXAGLIPTINE, ALSMEDE; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
2498758 CA 2020 00017 Denmark   Start Trial PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
2139494 LUC00176 Luxembourg   Start Trial PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
2139494 2020C/533 Belgium   Start Trial PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
1084705 PA2014043 Lithuania   Start Trial PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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