SAXAGLIPTIN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for saxagliptin hydrochloride and what is the scope of patent protection?

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.

Summary for SAXAGLIPTIN HYDROCHLORIDE

International Patents:	57
US Patents:	1
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	121
Patent Applications:	5
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAXAGLIPTIN HYDROCHLORIDE
DailyMed Link:	SAXAGLIPTIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for SAXAGLIPTIN HYDROCHLORIDE

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

Sponsor	Phase
University of Erlangen-Nürnberg Medical School	Phase 4
Ain Shams University	N/A
Sabyasachi Sen	Phase 3

See all SAXAGLIPTIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for SAXAGLIPTIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 5MG BASE	TABLET;ORAL
		EQ 2.5MG BASE	TABLET;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

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

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
Glenmark Pharms Ltd	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205994-001	Jul 31, 2023	AB	RX	No	No
Sun Pharm	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	206078-001	Jul 31, 2023	AB	RX	No	No
Sun Pharm	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	206078-002	Jul 31, 2023	AB	RX	No	No
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009		DISCN	Yes	No			Y
Mylan	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205980-001	Jul 31, 2023	AB	RX	No	No
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-001	Jul 31, 2023		DISCN	No	No
Aurobindo Pharma	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205972-002	Jul 31, 2023	AB	RX	No	No

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	022350-002	Jul 31, 2009
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009

International Patents for SAXAGLIPTIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Montenegro	02643	FORMULACIJA I METOD OBLOŽENE TABLETE (COATED T ABLET FORMULATION AND METHOD)
Malaysia	147639	COATED TABLET FORMULATION AND METHOD
Slovenia	2298288
Poland	2298288
European Patent Office	2298288	Formulation de comprime revêtu et procède correspondant (Coated tablet formulation and method)
Poland	1753406
Mexico	PA06013711	FORMULACION DE TABLETA REVESTIDA Y METODO. (COATED TABLET FORMULATION AND METHOD.)

Supplementary Protection Certificates for SAXAGLIPTIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	132020000000034	Italy		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
1261586	132012902044560	Italy		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
2498758	2020C/509	Belgium		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
1261586	10C0010	France		PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE CHLORHYDRATE DE SAXAGLIPTINE; NAT. REGISTRATION NO/DATE: EU/1/09/545/001 20091001; FIRST REGISTRATION: EU/1/09/454/001 20091001
2498758	LUC00152	Luxembourg		PRODUCT NAME: 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
1261586	C01261586/02	Switzerland		PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
1261586	1290013-0	Sweden		PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124