Details for New Drug Application (NDA): 209091
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The generic ingredient in QTERN 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 209091
Tradename: | QTERN |
Applicant: | Astrazeneca Ab |
Ingredient: | dapagliflozin; saxagliptin hydrochloride |
Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209091
Generic Entry Date for 209091*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 209091
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 209091
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6770 | 0310-6770-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30) |
QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6780 | 0310-6780-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-6780-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;EQ 5MG BASE | ||||
Approval Date: | Feb 27, 2017 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 4, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF TYPE 2 DIABETES MELLITUS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 16, 2029 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 21, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 209091
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