Details for New Drug Application (NDA): 213498
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NDA 213498 describes PONVORY, which is a drug marketed by Vanda Pharms Inc and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the PONVORY profile page.
The generic ingredient in PONVORY is ponesimod. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ponesimod profile page.
The generic ingredient in PONVORY is ponesimod. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ponesimod profile page.
Summary for 213498
| Tradename: | PONVORY |
| Applicant: | Vanda Pharms Inc |
| 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 | Vanda Pharmaceuticals Inc. | 43068-610 | 43068-610-09 | 1 KIT in 1 CARTON (43068-610-09) * 1 BLISTER PACK in 1 CARTON (43068-606-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-609-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-608-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-607-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-611-00) / 3 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-605-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-604-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-603-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-602-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK |
| PONVORY | ponesimod | TABLET;ORAL | 213498 | NDA | Vanda Pharmaceuticals Inc. | 43068-620 | 43068-620-01 | 1 BOTTLE in 1 CARTON (43068-620-01) / 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: | 10,220,023 | 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: | 11,951,097 | Patent Expiration: | Oct 10, 2042 | 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 BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT | ||||||||
Expired US Patents for NDA 213498
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-006 | Mar 18, 2021 | 9,000,018 | ⤷ Start Trial |
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-006 | Mar 18, 2021 | 8,273,779 | ⤷ Start Trial |
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-010 | Mar 18, 2021 | 9,000,018 | ⤷ Start Trial |
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-009 | Mar 18, 2021 | 8,273,779 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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