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Last Updated: May 18, 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.

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
⤷ Try a Trial	⤷ Try a Trial	EQ 5MG BASE	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-001	Jul 31, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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
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
Mylan	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205980-001	Jul 31, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	206078-002	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	022350-001	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	022350-001	Jul 31, 2009	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for saxagliptin hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Malaysia	147639	COATED TABLET FORMULATION AND METHOD	⤷ Try a Trial
Denmark	2298288		⤷ Try a Trial
Cyprus	1117813		⤷ Try a Trial
Israel	218117	טבליה המכילה סאקסאגליפטין ומספר שכבות ציפוי (Tablet comprising saxagliptin and multiple coating layers)	⤷ Try a Trial
Spain	2593582		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for saxagliptin hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	2010C/008	Belgium	⤷ Try a Trial	PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, COMPRENANT LE CHLORHYDRATE DE SAXAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/09/545001 20091005
1084705	SPC/GB14/085	United Kingdom	⤷ Try a Trial	PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
2139494	2020C/533	Belgium	⤷ Try a Trial	PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
2139494	301054	Netherlands	⤷ Try a Trial	PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
1084705	PA2014043	Lithuania	⤷ Try a 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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