Details for New Drug Application (NDA): 215830
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NDA 215830 describes LITFULO, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the LITFULO profile page.
The generic ingredient in LITFULO is ritlecitinib tosylate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ritlecitinib tosylate profile page.
The generic ingredient in LITFULO is ritlecitinib tosylate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ritlecitinib tosylate profile page.
Summary for 215830
| Tradename: | LITFULO |
| Applicant: | Pfizer |
| Ingredient: | ritlecitinib tosylate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215830
Generic Entry Date for 215830*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 215830
Suppliers and Packaging for NDA: 215830
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LITFULO | ritlecitinib tosylate | CAPSULE;ORAL | 215830 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0334 | 0069-0334-28 | 28 CAPSULE in 1 BOTTLE (0069-0334-28) |
| LITFULO | ritlecitinib tosylate | CAPSULE;ORAL | 215830 | NDA | U.S. Pharmaceuticals | 63539-334 | 63539-334-28 | 28 CAPSULE in 1 BOTTLE (63539-334-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Jun 23, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 23, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 3, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING SEVERE ALOPECIA AREATA IN ADULTS AND ADOLESCENTS 12 YEARS AND OLDER BY ADMINISTERING RITLECTINIB | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 17, 2041 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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