# OSMOLEX ER — FDA application NDA209410

Informational only - not investment advice.

Application NDA209410 · type NDA · FDA status: approved · original approval 2018-02-16

Listed sponsor: SUPERNUS PHARMS · [SUPN company profile](/company/SUPN/) · 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 | OSMOLEX ER | AMANTADINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | ORAL | EQ 129MG BASE | Discontinued | not listed | Yes |
| 002 | OSMOLEX ER | AMANTADINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | ORAL | EQ 193MG BASE | Discontinued | not listed | Yes |
| 003 | OSMOLEX ER | AMANTADINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | ORAL | EQ 258MG BASE | Discontinued | not listed | Yes |
| 004 | OSMOLEX ER | AMANTADINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | ORAL | EQ 161MG BASE | Discontinued | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 8389578, product 001; listed patent expiry date: 2028-01-22.
- Patent 8389578, product 001; listed patent expiry date: 2028-01-22.
- Patent 8389578, product 002; listed patent expiry date: 2028-01-22.
- Patent 8389578, product 002; listed patent expiry date: 2028-01-22.
- Patent 8389578, product 003; listed patent expiry date: 2028-01-22.
- Patent 8389578, product 003; listed patent expiry date: 2028-01-22.
- Patent 8389578, product 004; listed patent expiry date: 2028-01-22.
- Patent 8389578, product 004; listed patent expiry date: 2028-01-22.
- Patent 8252331, product 001; listed patent expiry date: 2030-03-13.
- Patent 8252331, product 002; listed patent expiry date: 2030-03-13.
- Patent 8252331, product 003; listed patent expiry date: 2030-03-13.
- Patent 8252331, product 004; listed patent expiry date: 2030-03-13.
- Patent 10213393, product 001; listed patent expiry date: 2038-02-15.
- Patent 10213393, product 002; listed patent expiry date: 2038-02-15.
- Patent 10213393, product 003; listed patent expiry date: 2038-02-15.
- Patent 10213393, product 004; listed patent expiry date: 2038-02-15.
- Patent 10213394, product 001; listed patent expiry date: 2038-02-15.
- Patent 10213394, product 002; listed patent expiry date: 2038-02-15.
- Patent 10213394, product 003; listed patent expiry date: 2038-02-15.
- Patent 10213394, product 004; listed patent expiry date: 2038-02-15.
- Patent 10500170, product 001; listed patent expiry date: 2038-02-15.
- Patent 10500170, product 002; listed patent expiry date: 2038-02-15.
- Patent 10500170, product 003; listed patent expiry date: 2038-02-15.
- Patent 10500170, product 004; listed patent expiry date: 2038-02-15.
- Patent 10500171, product 001; listed patent expiry date: 2038-02-15.
- Patent 10500171, product 002; listed patent expiry date: 2038-02-15.
- Patent 10500171, product 003; listed patent expiry date: 2038-02-15.
- Patent 10500171, product 004; listed patent expiry date: 2038-02-15.
- Patent 10500172, product 001; listed patent expiry date: 2038-02-15.
- Patent 10500172, product 002; listed patent expiry date: 2038-02-15.
- Patent 10500172, product 003; listed patent expiry date: 2038-02-15.
- Patent 10500172, product 004; listed patent expiry date: 2038-02-15.
- Patent 10512617, product 001; listed patent expiry date: 2038-02-15.
- Patent 10512617, product 002; listed patent expiry date: 2038-02-15.
- Patent 10512617, product 003; listed patent expiry date: 2038-02-15.
- Patent 10512617, product 004; listed patent expiry date: 2038-02-15.
- Patent 11890261, product 001; listed patent expiry date: 2038-02-15.
- Patent 11890261, product 002; listed patent expiry date: 2038-02-15.

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

- AMANTADINE HYDROCHLORIDE · 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/SUPN/)
- [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:NDA209410. FDA data retrieved 2026-08-07.

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