Details for New Drug Application (NDA): 213736
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NDA 213736 describes PEMAZYRE, which is a drug marketed by Incyte Corp and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the PEMAZYRE profile page.
The generic ingredient in PEMAZYRE is pemigatinib. One supplier is listed for this compound. Additional details are available on the pemigatinib profile page.
The generic ingredient in PEMAZYRE is pemigatinib. One supplier is listed for this compound. Additional details are available on the pemigatinib profile page.
Summary for 213736
| Tradename: | PEMAZYRE |
| Applicant: | Incyte Corp |
| Ingredient: | pemigatinib |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213736
Generic Entry Date for 213736*:
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: 213736
Suppliers and Packaging for NDA: 213736
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PEMAZYRE | pemigatinib | TABLET;ORAL | 213736 | NDA | Incyte Corporation | 50881-026 | 50881-026-01 | 14 TABLET in 1 BOTTLE, PLASTIC (50881-026-01) |
| PEMAZYRE | pemigatinib | TABLET;ORAL | 213736 | NDA | Incyte Corporation | 50881-027 | 50881-027-01 | 14 TABLET in 1 BOTTLE, PLASTIC (50881-027-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4.5MG | ||||
| Approval Date: | Apr 17, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 17, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Apr 17, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 26, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT | ||||||||
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