Details for New Drug Application (NDA): 202293
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NDA 202293 describes FARXIGA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from five suppliers. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FARXIGA profile page.
The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.
The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.
Summary for 202293
| Tradename: | FARXIGA |
| Applicant: | Astrazeneca Ab |
| Ingredient: | dapagliflozin |
| Patents: | 17 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202293
Generic Entry Date for 202293*:
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: 202293
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 202293
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FARXIGA | dapagliflozin | TABLET;ORAL | 202293 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6205 | 0310-6205-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30) |
| FARXIGA | dapagliflozin | TABLET;ORAL | 202293 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6205 | 0310-6205-90 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 8, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 8, 2026 | ||||||||
| Regulatory Exclusivity Use: | LABELING REVISIONS RELATED TO STUDY D1699CC00001 | ||||||||
| Regulatory Exclusivity Expiration: | Apr 30, 2024 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 4, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF TYPE 2 DIABETES MELLITUS | ||||||||
Expired US Patents for NDA 202293
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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