# PONVORY — FDA application NDA213498

Informational only - not investment advice.

Application NDA213498 · type NDA · FDA status: approved · original approval 2021-03-18

Listed sponsor: VANDA PHARMS INC · [VNDA company profile](/company/VNDA/) · 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 |

## Orange Book patent and exclusivity listings

- Patent RE43728, product 001; listed patent expiry date: 2029-11-16.
- Patent RE43728, product 002; listed patent expiry date: 2029-11-16.
- Patent RE43728, product 003; listed patent expiry date: 2029-11-16.
- Patent RE43728, product 004; listed patent expiry date: 2029-11-16.
- Patent RE43728, product 005; listed patent expiry date: 2029-11-16.
- Patent RE43728, product 006; listed patent expiry date: 2029-11-16.
- Patent RE43728, product 007; listed patent expiry date: 2029-11-16.
- Patent RE43728, product 008; listed patent expiry date: 2029-11-16.
- Patent RE43728, product 009; listed patent expiry date: 2029-11-16.
- Patent RE43728, product 010; listed patent expiry date: 2029-11-16.
- Patent 9062014, product 001; listed patent expiry date: 2032-05-06.
- Patent 9062014, product 002; listed patent expiry date: 2032-05-06.
- Patent 9062014, product 003; listed patent expiry date: 2032-05-06.
- Patent 9062014, product 004; listed patent expiry date: 2032-05-06.
- Patent 9062014, product 005; listed patent expiry date: 2032-05-06.
- Patent 9062014, product 006; listed patent expiry date: 2032-05-06.
- Patent 9062014, product 007; listed patent expiry date: 2032-05-06.
- Patent 9062014, product 008; listed patent expiry date: 2032-05-06.
- Patent 9062014, product 009; listed patent expiry date: 2032-05-06.
- Patent 9062014, product 010; listed patent expiry date: 2032-05-06.
- Patent 10220023, product 001; listed patent expiry date: 2035-12-10.
- Patent 10220023, product 002; listed patent expiry date: 2035-12-10.
- Patent 10220023, product 003; listed patent expiry date: 2035-12-10.
- Patent 10220023, product 004; listed patent expiry date: 2035-12-10.
- Patent 10220023, product 005; listed patent expiry date: 2035-12-10.
- Patent 10220023, product 006; listed patent expiry date: 2035-12-10.
- Patent 10220023, product 007; listed patent expiry date: 2035-12-10.
- Patent 10220023, product 008; listed patent expiry date: 2035-12-10.
- Patent 10220023, product 009; listed patent expiry date: 2035-12-10.
- Patent 10220023, product 010; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 001; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 002; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 003; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 004; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 005; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 006; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 007; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 008; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 009; listed patent expiry date: 2035-12-10.
- Patent 12336980, product 010; listed patent expiry date: 2035-12-10.
- Patent 11951097, product 001; listed patent expiry date: 2042-10-10.
- Patent 11951097, product 002; listed patent expiry date: 2042-10-10.
- Patent 11951097, product 003; listed patent expiry date: 2042-10-10.
- Patent 11951097, product 004; listed patent expiry date: 2042-10-10.
- Patent 11951097, product 005; listed patent expiry date: 2042-10-10.
- Patent 11951097, product 006; listed patent expiry date: 2042-10-10.
- Patent 11951097, product 007; listed patent expiry date: 2042-10-10.
- Patent 11951097, product 008; listed patent expiry date: 2042-10-10.
- Patent 11951097, product 009; listed patent expiry date: 2042-10-10.
- Patent 11951097, product 010; listed patent expiry date: 2042-10-10.
- Exclusivity NCE, product 001; listed exclusivity date: 2026-03-18.
- Exclusivity NCE, product 002; listed exclusivity date: 2026-03-18.
- Exclusivity NCE, product 003; listed exclusivity date: 2026-03-18.
- Exclusivity NCE, product 004; listed exclusivity date: 2026-03-18.
- Exclusivity NCE, product 005; listed exclusivity date: 2026-03-18.
- Exclusivity NCE, product 006; listed exclusivity date: 2026-03-18.
- Exclusivity NCE, product 007; listed exclusivity date: 2026-03-18.
- Exclusivity NCE, product 008; listed exclusivity date: 2026-03-18.
- Exclusivity NCE, product 009; listed exclusivity date: 2026-03-18.
- Exclusivity NCE, product 010; listed exclusivity date: 2026-03-18.

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](https://lmmol.com/compound/LPAUOXUZGSBGDU-STDDISTJSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/VNDA/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA213498. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.