Details for New Drug Application (NDA): 209091
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NDA 209091 describes QTERN, which is a drug marketed by Astrazeneca Ab and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QTERN profile page.
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.
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
*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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-002 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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