FDA Orange Book · active-ingredient family
Amantadine hydrochloride
Amantadine hydrochloride is approved as 5 brand and 37 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OSMOLEX ER · NDA 209410
5
Brand (NDA)
37
Generics (ANDA)
21
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release, syrup, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OSMOLEX ERRLD×4 | SUPERNUS PHARMS | NDA 209410 | — | Feb 16, 2018 | |
| GOCOVRIRLD×2 | SUPERNUS PHARMS | NDA 208944 | — | Aug 24, 2017 | |
| SYMMETRELRLD | ENDO PHARMS | NDA 016020 | — | Approved Prior to Jan 1, 1982 | |
| SYMMETRELRLD | ENDO PHARMS | NDA 016023 | — | Approved Prior to Jan 1, 1982 | |
| SYMMETRELRLD | ENDO PHARMS | NDA 018101 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (37)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | ZHEJIANG JUTAI PHARM | ANDA 218598 | AB | Sep 26, 2024 | |
| AMANTADINE HYDROCHLORIDE | ZYDUS | ANDA 214897 | — | Aug 26, 2024 | |
| AMANTADINE HYDROCHLORIDE | HUMANWELL PURACAP | ANDA 214580 | AB | Dec 20, 2022 | |
| AMANTADINE HYDROCHLORIDE | ADAPTIS | ANDA 212407 | — | May 27, 2022 | |
| AMANTADINE HYDROCHLORIDE | ONESOURCE SPECIALTY | ANDA 211354 | AB | Feb 18, 2022 | |
| AMANTADINE HYDROCHLORIDE | POM PHARMA | ANDA 214178 | AA | Aug 20, 2021 | |
| AMANTADINE HYDROCHLORIDE | ALEMBIC | ANDA 214284 | AB | Oct 15, 2020 | |
| AMANTADINE HYDROCHLORIDE | RUBICON RESEARCH | ANDA 212044 | AB | May 21, 2020 | |
| AMANTADINE HYDROCHLORIDE | POM PHARMA | ANDA 210215 | AB | Mar 10, 2020 | |
| AMANTADINE HYDROCHLORIDE | RISING | ANDA 210129 | AB | Mar 02, 2020 | |
| AMANTADINE HYDROCHLORIDE | JUBILANT GENERICS | ANDA 210403 | — | Feb 07, 2018 | |
| AMANTADINE HYDROCHLORIDE | ALEMBIC | ANDA 208966 | AB | Jun 21, 2017 | |
| AMANTADINE HYDROCHLORIDE | CHARTWELL MOLECULAR | ANDA 209221 | — | Jun 15, 2017 | |
| AMANTADINE HYDROCHLORIDE | HERITAGE PHARMA | ANDA 209171 | AB | Jun 12, 2017 | |
| AMANTADINE HYDROCHLORIDE | STRIDES PHARMA | ANDA 209035 | AB | Jun 09, 2017 | |
| AMANTADINE HYDROCHLORIDE | STRIDES PHARMA | ANDA 209047 | AB | Jun 07, 2017 | |
| AMANTADINE HYDROCHLORIDE | INVAGEN PHARMS | ANDA 207571 | — | Jan 31, 2017 | |
| AMANTADINE HYDROCHLORIDE | WATSON LABS INC | ANDA 208096 | AB | Dec 15, 2016 | |
| AMANTADINE HYDROCHLORIDE | WATSON LABS INC | ANDA 208107 | — | Dec 06, 2016 | |
| AMANTADINE HYDROCHLORIDE | INVAGEN PHARMS | ANDA 207570 | — | Sep 30, 2016 | |
| AMANTADINE HYDROCHLORIDE | ZYDUS PHARMS | ANDA 208278 | AB | May 31, 2016 | |
| AMANTADINE HYDROCHLORIDE | BIONPHARMA | ANDA 078720 | AB | May 29, 2008 | |
| AMANTADINE HYDROCHLORIDE | PH HEALTH | ANDA 077992 | — | Dec 12, 2006 | |
| AMANTADINE HYDROCHLORIDE | ACTAVIS ELIZABETH | ANDA 077659 | — | Feb 23, 2006 | |
| AMANTADINE HYDROCHLORIDE | CHARTWELL RX | ANDA 076352 | — | Sep 10, 2004 | |
| AMANTADINE HYDROCHLORIDE | UPSHER SMITH LABS | ANDA 076186 | AB | Dec 16, 2002 | |
| AMANTADINE HYDROCHLORIDE | ADAPTIS | ANDA 075819 | — | Sep 11, 2002 | |
| AMANTADINE HYDROCHLORIDE | PHARMOBEDIENT | ANDA 075060 | AA | Dec 24, 1998 | |
| AMANTADINE HYDROCHLORIDE | PHARM ASSOC | ANDA 074509 | AA | Jul 17, 1995 | |
| AMANTADINE HYDROCHLORIDE | AUROBINDO PHARMA USA | ANDA 074170 | AA | Oct 28, 1994 | |
| AMANTADINE HYDROCHLORIDE | CHARTWELL RX | ANDA 074028 | AA | Jun 28, 1993 | |
| AMANTADINE HYDROCHLORIDE | TEVA PHARMS | ANDA 073115 | — | Aug 23, 1991 | |
| AMANTADINE HYDROCHLORIDE | G AND W LABS INC | ANDA 072655 | — | Oct 30, 1990 | |
| AMANTADINE HYDROCHLORIDE | SANDOZ | ANDA 071293 | AB | Feb 18, 1987 | |
| AMANTADINE HYDROCHLORIDE | WATSON LABS | ANDA 071382 | — | Jan 21, 1987 | |
| SYMADINE | SOLVAY | ANDA 071000 | — | Sep 04, 1986 | |
| AMANTADINE HYDROCHLORIDE | UPSHER SMITH LABS | ANDA 070589 | AB | Aug 05, 1986 |
Listed patents (21)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8389578 | Jan 22, 2028 | in 1 yr 7 mo | U-2105 |
| 8252331 | Mar 13, 2030 | in 3 yr 9 mo | Product |
| 9867792 | Dec 02, 2030 | in 4 yr 6 mo | U-2106 |
| 9867791 | Dec 02, 2030 | in 4 yr 6 mo | U-2106 |
| 9877933 | Dec 02, 2030 | in 4 yr 6 mo | U-2224 |
| 8741343 | Dec 02, 2030 | in 4 yr 6 mo | U-2106 |
| 9867793 | Dec 02, 2030 | in 4 yr 6 mo | U-2106 |
| 11197835 | Dec 02, 2030 | in 4 yr 6 mo | U-2106 |
| 10646456 | Jun 17, 2034 | in 8 yr 1 mo | U-2808 |
| 11903908 | Jun 17, 2034 | in 8 yr 1 mo | U-3822 |
| 10154971 | Dec 04, 2034 | in 8 yr 7 mo | U-2459 |
| 10213393 | Feb 15, 2038 | in 11 yr 10 mo | U-20 |
| 10213394 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
| 10500171 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
| 10500172 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
| 10500170 | Feb 15, 2038 | in 11 yr 10 mo | U-20 |
| 10512617 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
| 11890261 | Feb 15, 2038 | in 11 yr 10 mo | U-2497 |
| 12233033 | Aug 23, 2038 | in 12 yr 4 mo | U-2106 |
| 11077073 | Aug 23, 2038 | in 12 yr 4 mo | U-2106 |
| 11065213 | Aug 23, 2038 | in 12 yr 4 mo | Product |
Amantadine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
