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Last Updated: September 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210874


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NDA 210874 describes QTERNMET XR, which is a drug marketed by Astrazeneca Ab and is included in one NDA. There are seven patents protecting this drug. Additional details are available on the QTERNMET XR profile page.

The generic ingredient in QTERNMET XR is dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride. There are twenty-six drug master file entries for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride profile page.
Summary for 210874
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 210874
Generic Entry Date for 210874*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG;1GM;EQ 2.5MG BASE
Approval Date:May 2, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:May 2, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Free Forever TrialPatent Expiration:Oct 4, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TYPE 2 DIABETES MELLITUS
Patent:⤷  Free Forever TrialPatent Expiration:Dec 16, 2029Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 210874

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-001 May 2, 2019 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-002 May 2, 2019 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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