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 is one patent protecting this drug. Additional details are available on the ZOKINVY profile page.
The generic ingredient in ZOKINVY is lonafarnib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lonafarnib profile page.
The generic ingredient in ZOKINVY is lonafarnib. There is one drug master file entry for this compound. 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: | 1 |
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 | Sentynl Therapeutics, Inc. | 42358-450 | 42358-450-30 | 1 BOTTLE, PLASTIC in 1 CARTON (42358-450-30) / 30 CAPSULE in 1 BOTTLE, PLASTIC |
| ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969 | NDA | Sentynl Therapeutics, Inc. | 42358-475 | 42358-475-30 | 1 BOTTLE, PLASTIC in 1 CARTON (42358-475-30) / 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, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND PROGEROID LAMINOPATHIES | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 26, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCING THE RISK OF MORTALITY IN HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
| Approval Date: | Nov 20, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 20, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND PROGEROID LAMINOPATHIES | ||||||||
Expired US Patents for NDA 213969
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sentynl Theraps Inc | ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969-001 | Nov 20, 2020 | ⤷ Start Trial | ⤷ Start Trial |
| Sentynl Theraps Inc | ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969-002 | Nov 20, 2020 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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