Details for New Drug Application (NDA): 216956
NDA 216956 describes VELSIPITY, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the VELSIPITY profile page.
The generic ingredient in VELSIPITY is etrasimod arginine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the etrasimod arginine profile page.
The generic ingredient in VELSIPITY is etrasimod arginine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the etrasimod arginine profile page.
Summary for 216956
| Tradename: | VELSIPITY |
| Applicant: | Pfizer |
| Ingredient: | etrasimod arginine |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216956
Generic Entry Date for 216956*:
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: 216956
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Suppliers and Packaging for NDA: 216956
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VELSIPITY | etrasimod arginine | TABLET;ORAL | 216956 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0274 | 0069-0274-30 | 1 BOTTLE in 1 CARTON (0069-0274-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Oct 12, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 12, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,301,262 | Patent Expiration: | Jun 21, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 10,676,435 | Patent Expiration: | Jun 21, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING ULCERATIVE COLITIS BY ADMINISTERING A THERAPEUTICALLY EFFECTIVE AMOUNT OF THE FORM OF ESTRASIMOD ARGININE AS CLAIMED | ||||||||
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