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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Julphar
Fish and Richardson
Chinese Patent Office
AstraZeneca
Express Scripts
US Army
Chubb
Cantor Fitzgerald
Queensland Health

Generated: October 20, 2017

DrugPatentWatch Database Preview

ONGLYZA Drug Profile

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What is the patent landscape for Onglyza, and what generic Onglyza 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 eighteen patent family members in thirty-nine countries and twenty-two supplementary protection certificates in eleven countries.

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

Summary for Tradename: ONGLYZA

US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list39
Clinical Trials: see list64
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ONGLYZA at DailyMed

Pharmacology for Tradename: 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;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ONGLYZA

Drugname Dosage Strength RLD Submissiondate
saxagliptin hydrochlorideTablets2.5 mg and 5 mgOnglyza7/31/2013

Non-Orange Book Patents for Tradename: ONGLYZA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,628,799Coated tablet formulation and method► Subscribe
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method► Subscribe
9,339,472Coated tablet formulation and method► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ONGLYZA

Country Document Number Estimated Expiration
European Patent Office1753406► Subscribe
Japan2015134830► Subscribe
Luxembourg91650► Subscribe
Slovenia2298288► Subscribe
Israel151372► Subscribe
Israel177018► Subscribe
South Korea20060026125► Subscribe
Hong Kong1152516► Subscribe
Peru04252006► Subscribe
Ukraine88168► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ONGLYZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0028France► SubscribePRODUCT 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
00524Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
650Luxembourg► Subscribe91650, EXPIRES: 20241001
C/GB10/001United Kingdom► SubscribePRODUCT 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
00707Netherlands► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
1084705/03Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
C0010France► SubscribePRODUCT 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
/2012Austria► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
4/2010Austria► SubscribePRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
985Luxembourg► Subscribe91985, EXPIRES: 20260305
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Johnson and Johnson
Farmers Insurance
Cipla
QuintilesIMS
Harvard Business School
Federal Trade Commission
Argus Health
Queensland Health
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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