Details for New Drug Application (NDA): 211566
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NDA 211566 describes ZITUVIO, which is a drug marketed by Zydus Lifesciences and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ZITUVIO profile page.
The generic ingredient in ZITUVIO is sitagliptin. There are thirty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sitagliptin profile page.
The generic ingredient in ZITUVIO is sitagliptin. There are thirty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sitagliptin profile page.
Summary for 211566
| Tradename: | ZITUVIO |
| Applicant: | Zydus Lifesciences |
| Ingredient: | sitagliptin |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211566
Generic Entry Date for 211566*:
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: 211566
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 211566
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZITUVIO | sitagliptin | TABLET;ORAL | 211566 | NDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1240 | 70710-1240-3 | 30 TABLET in 1 BOTTLE (70710-1240-3) |
| ZITUVIO | sitagliptin | TABLET;ORAL | 211566 | NDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1240 | 70710-1240-9 | 90 TABLET in 1 BOTTLE (70710-1240-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 18, 2023 | TE: | RLD: | Yes | |||||
| Patent: | 10,925,871 | Patent Expiration: | Feb 25, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 18, 2023 | TE: | RLD: | Yes | |||||
| Patent: | 10,925,871 | Patent Expiration: | Feb 25, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Oct 18, 2023 | TE: | RLD: | Yes | |||||
| Patent: | 10,925,871 | Patent Expiration: | Feb 25, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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