ONGLYZA Drug Patent Profile

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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 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

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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

Drug patent expirations by year 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

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

Coated tablet formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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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
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 ONGLYZA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ONGLYZA

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005117841		⤷ Sign Up
European Patent Office	1261586	INHIBITEURS DE LA DIPEPTIDYL-PEPTIDASE IV COMPRENANT UNE PYRROLIDINE ET UN CYCLOPROPYLE FUSIONNES, PROCEDES POUR LEUR PREPARATION ET UTILISATION DE CES COMPOSES (CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITORS OF DIPEPTIDYL PEPTIDASE IV, PROCESSES FOR THEIR PREPARATION, AND THEIR USE)	⤷ Sign Up
Spain	2754573		⤷ Sign Up
Japan	5427047		⤷ Sign Up
Israel	179454	COATED TABLET FORMULATION COMPRISING SAXAGLIPTIN AND METHOD FOR PREPARING THE SAME	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ONGLYZA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	SZ 4/2010	Austria	⤷ Sign Up	PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
2139494	301054	Netherlands	⤷ Sign Up	PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
2498758	132020000000034	Italy	⤷ Sign Up	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
2139494	2020C/533	Belgium	⤷ Sign Up	PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
2139494	34/2020	Austria	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description