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ONGLYZA Drug Profile

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

This drug has eighty-nine patent family members in thirty-four countries.

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

Summary for Tradename: ONGLYZA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list4

Pharmacology for Tradename: ONGLYZA

Clinical Trials for: ONGLYZA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXNoRE44186<disabled>YY <disabled>
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXNo<disabled><disabled>
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYes7,951,400<disabled>Y <disabled>
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Paragraph IV activity 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<disabled in preview>
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method<disabled in preview>
9,339,472Coated tablet formulation and method<disabled in preview>
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International Patent Family for Tradename: ONGLYZA

Country Document Number Estimated Expiration
Russian Federation2002125491<disabled in preview>
European Patent Office2995615<disabled in preview>
South Korea20070027560<disabled in preview>
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Supplementary Protection Certificates for Tradename: ONGLYZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00062Denmark<disabled>PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
1084705/03Switzerland<disabled>PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
C0010France<disabled>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
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