PONVORY — FDA application NDA213498
Listed sponsor: VANDA PHARMS INC · VNDA company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | PONVORY | PONESIMOD | TABLET | ORAL | 2MG | Prescription | not listed | Yes |
| 002 | PONVORY | PONESIMOD | TABLET | ORAL | 3MG | Prescription | not listed | Yes |
| 003 | PONVORY | PONESIMOD | TABLET | ORAL | 4MG | Prescription | not listed | Yes |
| 004 | PONVORY | PONESIMOD | TABLET | ORAL | 5MG | Prescription | not listed | Yes |
| 005 | PONVORY | PONESIMOD | TABLET | ORAL | 6MG | Prescription | not listed | Yes |
| 006 | PONVORY | PONESIMOD | TABLET | ORAL | 7MG | Prescription | not listed | Yes |
| 007 | PONVORY | PONESIMOD | TABLET | ORAL | 8MG | Prescription | not listed | Yes |
| 008 | PONVORY | PONESIMOD | TABLET | ORAL | 9MG | Prescription | not listed | Yes |
| 009 | PONVORY | PONESIMOD | TABLET | ORAL | 10MG | Prescription | not listed | Yes |
| 010 | PONVORY | PONESIMOD | TABLET | ORAL | 20MG | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent RE43728 | 001 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent RE43728 | 002 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent RE43728 | 003 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent RE43728 | 004 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent RE43728 | 005 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent RE43728 | 006 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent RE43728 | 007 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent RE43728 | 008 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent RE43728 | 009 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent RE43728 | 010 | listed patent expiry date: 2029-11-16 | drug substance, drug product |
| Patent 9062014 | 001 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 9062014 | 002 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 9062014 | 003 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 9062014 | 004 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 9062014 | 005 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 9062014 | 006 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 9062014 | 007 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 9062014 | 008 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 9062014 | 009 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 9062014 | 010 | listed patent expiry date: 2032-05-06 | drug substance, drug product, U-2774 |
| Patent 10220023 | 001 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 10220023 | 002 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 10220023 | 003 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 10220023 | 004 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 10220023 | 005 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 10220023 | 006 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 10220023 | 007 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 10220023 | 008 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 10220023 | 009 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 10220023 | 010 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 001 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 002 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 003 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 004 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 005 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 006 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 007 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 008 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 009 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 12336980 | 010 | listed patent expiry date: 2035-12-10 | U-3103 |
| Patent 11951097 | 001 | listed patent expiry date: 2042-10-10 | U-3891 |
| Patent 11951097 | 002 | listed patent expiry date: 2042-10-10 | U-3891 |
| Patent 11951097 | 003 | listed patent expiry date: 2042-10-10 | U-3891 |
| Patent 11951097 | 004 | listed patent expiry date: 2042-10-10 | U-3891 |
| Patent 11951097 | 005 | listed patent expiry date: 2042-10-10 | U-3891 |
| Patent 11951097 | 006 | listed patent expiry date: 2042-10-10 | U-3891 |
| Patent 11951097 | 007 | listed patent expiry date: 2042-10-10 | U-3891 |
| Patent 11951097 | 008 | listed patent expiry date: 2042-10-10 | U-3891 |
| Patent 11951097 | 009 | listed patent expiry date: 2042-10-10 | U-3891 |
| Patent 11951097 | 010 | listed patent expiry date: 2042-10-10 | U-3891 |
| Exclusivity NCE | 001 | listed exclusivity date: 2026-03-18 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2026-03-18 | FDA code as listed |
| Exclusivity NCE | 003 | listed exclusivity date: 2026-03-18 | FDA code as listed |
| Exclusivity NCE | 004 | listed exclusivity date: 2026-03-18 | FDA code as listed |
| Exclusivity NCE | 005 | listed exclusivity date: 2026-03-18 | FDA code as listed |
| Exclusivity NCE | 006 | listed exclusivity date: 2026-03-18 | FDA code as listed |
| Exclusivity NCE | 007 | listed exclusivity date: 2026-03-18 | FDA code as listed |
| Exclusivity NCE | 008 | listed exclusivity date: 2026-03-18 | FDA code as listed |
| Exclusivity NCE | 009 | listed exclusivity date: 2026-03-18 | FDA code as listed |
| Exclusivity NCE | 010 | listed exclusivity date: 2026-03-18 | FDA code as listed |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- PONESIMOD · UNII 5G7AKV2MKP · lmmol compound LPAUOXUZGSBGDU-STDDISTJSA-N · CHEMBL1096146
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.