# DUZALLO — FDA application NDA209203

Informational only - not investment advice.

Application NDA209203 · type NDA · FDA status: approved · original approval 2017-08-18

Listed sponsor: IRONWOOD PHARMS INC · [IRWD company profile](/company/IRWD/) · 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 | DUZALLO | ALLOPURINOL; LESINURAD | TABLET | ORAL | 200MG;200MG | Discontinued | not listed | Yes |
| 002 | DUZALLO | ALLOPURINOL; LESINURAD | TABLET | ORAL | 300MG;200MG | Discontinued | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10183012, product 001; listed patent expiry date: 2028-11-26.
- Patent 10183012, product 002; listed patent expiry date: 2028-11-26.
- Patent 8283369, product 001; listed patent expiry date: 2028-11-26.
- Patent 8283369, product 002; listed patent expiry date: 2028-11-26.
- Patent 8546437, product 001; listed patent expiry date: 2029-04-29.
- Patent 8546437, product 002; listed patent expiry date: 2029-04-29.
- Patent 8084483, product 001; listed patent expiry date: 2029-08-17.
- Patent 8084483, product 002; listed patent expiry date: 2029-08-17.
- Patent 8357713, product 001; listed patent expiry date: 2029-12-22.
- Patent 8357713, product 002; listed patent expiry date: 2029-12-22.
- Patent 9216179, product 001; listed patent expiry date: 2031-08-01.
- Patent 9216179, product 002; listed patent expiry date: 2031-08-01.
- Patent 9956205, product 001; listed patent expiry date: 2031-12-28.
- Patent 9956205, product 002; listed patent expiry date: 2031-12-28.
- Patent 8546436, product 001; listed patent expiry date: 2032-02-29.
- Patent 8546436, product 002; listed patent expiry date: 2032-02-29.

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

- ALLOPURINOL; LESINURAD · UNII not resolved · no lmmol compound match

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/IRWD/)
- [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:NDA209203. FDA data retrieved 2026-08-07.

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