Orange Book product · Brand (NDA)
OSMOLEX ER
AMANTADINE HYDROCHLORIDE
At a glance
Feb 16, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 16, 2018
8 yr 6 mo ago
Today
Patent 8389578 expires
Listed method-of-use patent (U-3054) expiration.
Jan 22, 2028
in 1 yr 7 mo
Patent 8389578 expires
Listed method-of-use patent (U-219) expiration.
Jan 22, 2028
in 1 yr 7 mo
Patent 8252331 expires
Listed drug product patent expiration.
Mar 13, 2030
in 3 yr 9 mo
Patent 10213393 expires
Listed method-of-use patent (U-20) expiration.
Feb 15, 2038
in 11 yr 10 mo
Patent 10213394 expires
Listed method-of-use patent (U-2497) expiration.
Feb 15, 2038
in 11 yr 10 mo
Patent 10500170 expires
Listed method-of-use patent (U-20) expiration.
Feb 15, 2038
in 11 yr 10 mo
Patent 10500171 expires
Listed method-of-use patent (U-2497) expiration.
Feb 15, 2038
in 11 yr 10 mo
Patent 10500172 expires
Listed method-of-use patent (U-2497) expiration.
Feb 15, 2038
in 11 yr 10 mo
Patent 10512617 expires
Listed method-of-use patent (U-2497) expiration.
Feb 15, 2038
in 11 yr 10 mo
Patent 11890261 expires
Listed method-of-use patent (U-2497) expiration.
Feb 15, 2038
in 11 yr 10 mo
Pharmaceutical detail
Active ingredient
AMANTADINE HYDROCHLORIDE
Strength
EQ 129MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 209410
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2017GOCOVRIBrand (NDA)
NDA 208944 · SUPERNUS PHARMS
- —SYMMETRELBrand (NDA)
NDA 016020 · ENDO PHARMS
- —SYMMETRELBrand (NDA)
NDA 016023 · ENDO PHARMS
- —SYMMETRELBrand (NDA)
NDA 018101 · ENDO PHARMS
- 2024AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218598 · ZHEJIANG JUTAI PHARM
- 2024AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214897 · ZYDUS
- 2022AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214580 · HUMANWELL PURACAP
- 2022AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212407 · ADAPTIS
- 2022AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211354 · ONESOURCE SPECIALTY
- 2021AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214178 · POM PHARMA
- 2020AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214284 · ALEMBIC
- 2020AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212044 · RUBICON RESEARCH
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8389578 | Jan 22, 2028 | in 1 yr 7 mo | U-3054 |
| 8389578 | Jan 22, 2028 | in 1 yr 7 mo | U-219 |
| 8252331 | Mar 13, 2030 | in 3 yr 9 mo | Product |
| 10213393 | Feb 15, 2038 | in 11 yr 10 mo | U-20 |
| 10213394 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
| 10500170 | Feb 15, 2038 | in 11 yr 10 mo | U-20 |
| 10500171 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
| 10500172 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
| 10512617 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
| 11890261 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
