ONGLYZA Drug Patent Profile

When do Onglyza patents expire, and when can generic versions of Onglyza launch?

Onglyza is a drug marketed by Astrazeneca Ab and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in thirty-two countries.

The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Onglyza

Onglyza was eligible for patent challenges on July 31, 2013.

There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (saxagliptin hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for ONGLYZA

International Patents:	57
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	68
Patent Applications:	4,141
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ONGLYZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONGLYZA
What excipients (inactive ingredients) are in ONGLYZA?	ONGLYZA excipients list
DailyMed Link:	ONGLYZA at DailyMed

See drug prices for ONGLYZA

See drug sales revenues for ONGLYZA

Recent Clinical Trials for ONGLYZA

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

Sponsor	Phase
Ain Shams University	N/A
Beni-Suef University	Phase 4
Sabyasachi Sen	Phase 4

See all ONGLYZA clinical trials

Pharmacology for ONGLYZA

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

Anatomical Therapeutic Chemical (ATC) Classes for ONGLYZA

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ONGLYZA

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 ONGLYZA

ONGLYZA is protected by one US patents.

Patents protecting ONGLYZA

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			Y
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009		DISCN	Yes	No			Y

Expired US Patents for ONGLYZA

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

International Patents for ONGLYZA

See the table below for patents covering ONGLYZA around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	551591	Coated tablet formulation and method
Japan	5427047
Japan	2010077163	CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITOR FOR DIPEPTIDYL PEPTIDASE IV, AND METHOD
European Patent Office	3078369	FORMULATION DE COMPRIMÉ REVÊTU ET PROCÉDÉ CORRESPONDANT (COATED TABLET FORMULATION AND METHOD)
Hungary	S1200030
Spain	2754573
Taiwan	I415635

Supplementary Protection Certificates for ONGLYZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	CR 2020 00017	Denmark		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
1261586	2010C/008	Belgium		PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, COMPRENANT LE CHLORHYDRATE DE SAXAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/09/545001 20091005
1261586	SPC/GB10/001	United Kingdom		PRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001
1261586	91985	Luxembourg		91985, EXPIRES: 20260305
2139494	2090034-6	Sweden		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE; REG. NO/DATE: EU/1/16/1108 20160719
2139494	LUC00176	Luxembourg		PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
2139494	CA 2020 00035	Denmark		PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719