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 six 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.
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
| Tradename: | QTERNMET XR |
| Applicant: | Astrazeneca Ab |
| Ingredient: | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG;1GM;EQ 2.5MG BASE | ||||
| Approval Date: | May 2, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 6,515,117 | Patent Expiration: | Oct 4, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF TYPE 2 DIABETES MELLITUS | ||||||||
| Patent: | 7,919,598 | Patent Expiration: | Dec 16, 2029 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 8,501,698 | Patent Expiration: | Jun 20, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF TYPE 2 DIABETES MELLITUS | ||||||||
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 | 210874-002 | May 2, 2019 | 9,198,925 | ⤷ Subscribe |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | 6,414,126 | ⤷ Subscribe |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-002 | May 2, 2019 | 6,414,126 | ⤷ Subscribe |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | 9,198,925 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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