Details for New Drug Application (NDA): 213969
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NDA 213969 describes ZOKINVY, which is a drug marketed by Sentynl Theraps Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ZOKINVY profile page.
The generic ingredient in ZOKINVY is lonafarnib. One supplier is listed for this compound. Additional details are available on the lonafarnib profile page.
The generic ingredient in ZOKINVY is lonafarnib. One supplier is listed for this compound. Additional details are available on the lonafarnib profile page.
Summary for 213969
| Tradename: | ZOKINVY |
| Applicant: | Sentynl Theraps Inc |
| Ingredient: | lonafarnib |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213969
Generic Entry Date for 213969*:
Constraining patent/regulatory exclusivity:
TREATMENT OF HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND PROGEROID LAMINOPATHIES 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: 213969
Suppliers and Packaging for NDA: 213969
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969 | NDA | Eiger BioPharmaceuticals, Inc. | 73079-050 | 73079-050-30 | 1 BOTTLE, PLASTIC in 1 CARTON (73079-050-30) / 30 CAPSULE in 1 BOTTLE, PLASTIC |
| ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969 | NDA | Eiger BioPharmaceuticals, Inc. | 73079-075 | 73079-075-30 | 1 BOTTLE, PLASTIC in 1 CARTON (73079-075-30) / 30 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Nov 20, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 20, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Nov 20, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND PROGEROID LAMINOPATHIES | ||||||||
| Patent: | 7,838,531 | Patent Expiration: | Jul 26, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCING THE RISK OF MORTALITY IN HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) | ||||||||
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