Details for New Drug Application (NDA): 213498
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NDA 213498 describes PONVORY, which is a drug marketed by Janssen Pharms 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 PONVORY profile page.
The generic ingredient in PONVORY is ponesimod. One supplier is listed for this compound. Additional details are available on the ponesimod profile page.
The generic ingredient in PONVORY is ponesimod. One supplier is listed for this compound. Additional details are available on the ponesimod profile page.
Summary for 213498
| Tradename: | PONVORY |
| Applicant: | Janssen Pharms |
| Ingredient: | ponesimod |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213498
Generic Entry Date for 213498*:
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: 213498
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Suppliers and Packaging for NDA: 213498
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PONVORY | ponesimod | TABLET;ORAL | 213498 | NDA | Janssen Pharmaceuticals, Inc | 50458-707 | 50458-707-14 | 1 KIT in 1 CARTON (50458-707-14) * 1 BLISTER PACK in 1 CARTON (50458-706-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-709-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-708-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-711-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-710-00) / 3 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-705-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-704-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-703-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-702-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK |
| PONVORY | ponesimod | TABLET;ORAL | 213498 | NDA | Janssen Pharmaceuticals, Inc | 50458-720 | 50458-720-30 | 1 BOTTLE in 1 CARTON (50458-720-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Mar 18, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 18, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 10, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS | ||||||||
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