Details for New Drug Application (NDA): 219209
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NDA 219209 describes JOURNAVX, which is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the JOURNAVX profile page.
The generic ingredient in JOURNAVX is suzetrigine. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the suzetrigine profile page.
The generic ingredient in JOURNAVX is suzetrigine. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the suzetrigine profile page.
Summary for 219209
| Tradename: | JOURNAVX |
| Applicant: | Vertex Pharms Inc |
| Ingredient: | suzetrigine |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219209
Generic Entry Date for 219209*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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: 219209
| Mechanism of Action | Cytochrome P450 3A Inducers Sodium Channel Antagonists |
Suppliers and Packaging for NDA: 219209
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JOURNAVX | suzetrigine | TABLET;ORAL | 219209 | NDA | Vertex Pharmaceuticals Incorporated | 51167-548 | 51167-548-25 | 5 BLISTER PACK in 1 CARTON (51167-548-25) / 5 TABLET, FILM COATED in 1 BLISTER PACK (51167-548-05) |
| JOURNAVX | suzetrigine | TABLET;ORAL | 219209 | NDA | Vertex Pharmaceuticals Incorporated | 51167-548 | 51167-548-30 | 30 TABLET, FILM COATED in 1 BOTTLE (51167-548-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 30, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 30, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 4, 2040 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF MODERATE TO SEVERE ACUTE PAIN IN ADULTS USING SUZETRIGINE | ||||||||
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