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US Department of Justice

Generated: March 20, 2019

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QTERN Drug Profile

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Which patents cover Qtern, 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-four patent family members in forty-seven countries.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six 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.

Drug patent expirations by year for QTERN
Generic Entry Opportunity Date for QTERN
Generic Entry Date for QTERN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 Date
➤ Subscribe Tablets 10 mg/5 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for QTERN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 300677 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1261586 SPC/GB10/001 United Kingdom ➤ Try a Free Trial PRODUCT 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
1506211 SPC/GB13/021 United Kingdom ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114
1506211 13C0022 France ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
1506211 136 5005-2013 Slovakia ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Baxter
Cipla
Daiichi Sankyo
Covington
Medtronic

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