OSMOLEX ER — FDA application NDA209410
Listed sponsor: SUPERNUS PHARMS · SUPN company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 8389578 | 001 | listed patent expiry date: 2028-01-22 | U-3054 |
| Patent 8389578 | 001 | listed patent expiry date: 2028-01-22 | U-219 |
| Patent 8389578 | 002 | listed patent expiry date: 2028-01-22 | U-219 |
| Patent 8389578 | 002 | listed patent expiry date: 2028-01-22 | U-3054 |
| Patent 8389578 | 003 | listed patent expiry date: 2028-01-22 | U-219 |
| Patent 8389578 | 003 | listed patent expiry date: 2028-01-22 | U-3054 |
| Patent 8389578 | 004 | listed patent expiry date: 2028-01-22 | U-3054 |
| Patent 8389578 | 004 | listed patent expiry date: 2028-01-22 | U-219 |
| Patent 8252331 | 001 | listed patent expiry date: 2030-03-13 | drug product |
| Patent 8252331 | 002 | listed patent expiry date: 2030-03-13 | drug product |
| Patent 8252331 | 003 | listed patent expiry date: 2030-03-13 | drug product |
| Patent 8252331 | 004 | listed patent expiry date: 2030-03-13 | drug product |
| Patent 10213393 | 001 | listed patent expiry date: 2038-02-15 | U-20 |
| Patent 10213393 | 002 | listed patent expiry date: 2038-02-15 | U-20 |
| Patent 10213393 | 003 | listed patent expiry date: 2038-02-15 | U-20 |
| Patent 10213393 | 004 | listed patent expiry date: 2038-02-15 | U-20 |
| Patent 10213394 | 001 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10213394 | 002 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10213394 | 003 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10213394 | 004 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10500170 | 001 | listed patent expiry date: 2038-02-15 | U-20 |
| Patent 10500170 | 002 | listed patent expiry date: 2038-02-15 | U-20 |
| Patent 10500170 | 003 | listed patent expiry date: 2038-02-15 | U-20 |
| Patent 10500170 | 004 | listed patent expiry date: 2038-02-15 | U-20 |
| Patent 10500171 | 001 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10500171 | 002 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10500171 | 003 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10500171 | 004 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10500172 | 001 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10500172 | 002 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10500172 | 003 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10500172 | 004 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10512617 | 001 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10512617 | 002 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10512617 | 003 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 10512617 | 004 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 11890261 | 001 | listed patent expiry date: 2038-02-15 | U-2497 |
| Patent 11890261 | 002 | listed patent expiry date: 2038-02-15 | U-2497 |
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 · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.