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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 ninety-one 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
Drug Prices: :see details

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, 2009RXNoRE44186Jul 31, 2023YY
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXNoMay 24, 2016
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYes7,951,400Nov 30, 2028Y
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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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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
Israel151372<disabled in preview>
New Zealand520821<disabled in preview>
Brazil0109115<disabled in preview>
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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
00524Netherlands<disabled>PRODUCT 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:
/2012Austria<disabled>PRODUCT 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
2014 00062Denmark<disabled>PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
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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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