# DEXTENZA — FDA application NDA208742

Informational only - not investment advice.

Application NDA208742 · type NDA · FDA status: approved · original approval 2018-11-30

Listed sponsor: OCULAR THERAPEUTIX · [OCUL company profile](/company/OCUL/) · 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 | DEXTENZA | DEXAMETHASONE | INSERT | OPHTHALMIC | 0.4MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 8563027, product 001; listed patent expiry date: 2030-02-12.
- Patent 8409606, product 001; listed patent expiry date: 2030-05-14.
- Patent 12150896, product 001; listed patent expiry date: 2036-10-07.
- Patent 12150896, product 001; listed patent expiry date: 2036-10-07.
- Patent 11458041, product 001; listed patent expiry date: 2037-11-16.
- Patent 11458041, product 001; listed patent expiry date: 2037-11-16.
- Patent 12144889, product 001; listed patent expiry date: 2041-04-26.
- Exclusivity NPP, product 001; listed exclusivity date: 2028-04-07.

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

- DEXAMETHASONE · UNII 7S5I7G3JQL · [lmmol compound UREBDLICKHMUKA-CXSFZGCWSA-N](https://lmmol.com/compound/UREBDLICKHMUKA-CXSFZGCWSA-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/OCUL/)
- [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:NDA208742. FDA data retrieved 2026-08-07.

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