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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
US Department of Justice
Baxter
US Army
Covington
AstraZeneca
Argus Health
Citi
Accenture

Generated: June 23, 2018

DrugPatentWatch Database Preview

QTERN Drug Profile

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When do Qtern patents expire, and when can generic versions of Qtern launch?

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

This drug has three hundred and twenty patent family members in forty-seven countries.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

US Patents and Regulatory Information for QTERN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for QTERN
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 10 mg/5 mg ➤ Subscribe 2018-01-08

Non-Orange Book US Patents for QTERN

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
9,339,472 Coated tablet formulation and method ➤ Sign Up
9,453,039 Crystal structures of SGLT2 inhibitors and processes for preparing same ➤ Sign Up
7,951,400 Coated tablet formulation and method ➤ Sign Up
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for QTERN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00524 Netherlands ➤ Sign Up 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:
2014000070 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
2014000071 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1261586/02 Switzerland ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Citi
McKesson
Cantor Fitzgerald
Dow
Boehringer Ingelheim
AstraZeneca
Fish and Richardson
Express Scripts

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