# ORILISSA — FDA application NDA210450

Informational only - not investment advice.

Application NDA210450 · type NDA · FDA status: approved · original approval 2018-07-23

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · 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 | ORILISSA | ELAGOLIX SODIUM | TABLET | ORAL | EQ 150MG BASE | Prescription | not listed | Yes |
| 002 | ORILISSA | ELAGOLIX SODIUM | TABLET | ORAL | EQ 200MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7419983, product 001; listed patent expiry date: 2029-07-06.
- Patent 7419983, product 002; listed patent expiry date: 2029-07-06.
- Patent 11344551, product 002; listed patent expiry date: 2034-03-14.
- Patent 11344551, product 002; listed patent expiry date: 2034-03-14.
- Patent 11707464, product 001; listed patent expiry date: 2034-03-14.
- Patent 10537572, product 001; listed patent expiry date: 2036-09-01.
- Patent 10682351, product 001; listed patent expiry date: 2036-09-01.
- Patent 11690854, product 001; listed patent expiry date: 2038-04-19.
- Patent 12102637, product 001; listed patent expiry date: 2038-08-20.
- Patent 12102637, product 002; listed patent expiry date: 2038-08-20.
- Patent 11542239, product 001; listed patent expiry date: 2039-07-23.
- Patent 11542239, product 002; listed patent expiry date: 2039-07-23.
- Patent 11690845, product 001; listed patent expiry date: 2040-08-27.
- Patent 11690845, product 002; listed patent expiry date: 2040-08-27.

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

- ELAGOLIX SODIUM · UNII 5948VUI423 · [lmmol compound DQYGXRQUFSRDCH-UQIIZPHYSA-M](https://lmmol.com/compound/DQYGXRQUFSRDCH-UQIIZPHYSA-M)

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/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

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:NDA210450. FDA data retrieved 2026-08-07.

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