ONGLYZA Drug Patent Profile

Which patents cover Onglyza, and what generic alternatives are available?

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

This drug has one hundred and twenty-seven patent family members in forty-one 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:	127
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	68
Patent Applications:	3,764
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ONGLYZA
Drug Sales Revenues:	Drug sales revenues 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 three 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	AB	RX	Yes	No			Y	Y
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009	AB	RX	Yes	Yes			Y	Y
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009	AB	RX	Yes	No			Y
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009	AB	RX	Yes	Yes			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	022350-002	Jul 31, 2009
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009

International Patents for ONGLYZA

When does loss-of-exclusivity occur for ONGLYZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I354569
Portugal	1261586
Spain	2582646
China	1213028
Argentina	099567	FORMULACIÓN DE TABLETA REVESTIDA QUE COMPRENDE SAXAGLIPTINA Y MÉTODO DE PREPARACIÓN
Hong Kong	1155399	加衣錠片調製物及製備彼之方法 (COATED TABLET FORMULATION AND METHOD)
Uruguay	26613	INHIBIDORES A BASE DE PIRROLIDINA FUSIONADA CON CICLOPROPILO DE DIPEPTIDIL PEPTIDASA IV Y MÉTODO

Supplementary Protection Certificates for ONGLYZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1261586	C01261586/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
1261586	12C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1261586	SPC005/2010	Ireland		SPC005/2010: 20100702, EXPIRES: 20240930
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
2139494	301054	Netherlands		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
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