Details for New Drug Application (NDA): 214793
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NDA 214793 describes PYLARIFY, which is a drug marketed by Progenics Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the PYLARIFY profile page.
The generic ingredient in PYLARIFY is piflufolastat f-18. One supplier is listed for this compound. Additional details are available on the piflufolastat f-18 profile page.
The generic ingredient in PYLARIFY is piflufolastat f-18. One supplier is listed for this compound. Additional details are available on the piflufolastat f-18 profile page.
Summary for 214793
| Tradename: | PYLARIFY |
| Applicant: | Progenics Pharms Inc |
| Ingredient: | piflufolastat f-18 |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214793
*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: 214793
| Mechanism of Action | Positron Emitting Activity |
Suppliers and Packaging for NDA: 214793
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYLARIFY | piflufolastat f-18 | SOLUTION;INTRAVENOUS | 214793 | NDA | Progenics Pharmaceuticals, Inc. | 71258-022 | 71258-022-01 | 50 mL in 1 VIAL, MULTI-DOSE (71258-022-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50ML (1-80mCi/ML) | ||||
| Approval Date: | May 26, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 26, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 9, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 9, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER | ||||||||
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