
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GOCOVRI | Supernus Pharmaceuticals | N-208944 RX | 2017-08-24 | 2 products, RLD, RS |
Brand Name | Status | Last Update |
|---|---|---|
| amantadine | ANDA | 2025-07-28 |
| amantadine hcl | ANDA | 2025-06-24 |
| amantadine hydrochloride | ANDA | 2025-10-24 |
| gocovri | New Drug Application | 2025-10-22 |
| symmetrel hard gel | ANDA | 2023-01-18 |
Expiration | Code | ||
|---|---|---|---|
AMANTADINE HYDROCHLORIDE, GOCOVRI, ADAMAS OPERATIONS | |||
| 2024-08-24 | ODE-153 | ||
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Amantadine Hydrochloride, Gocovri, Adamas Operations | |||
| 11065213 | 2038-08-23 | DP | |
| 11077073 | 2038-08-23 | U-2106, U-2224, U-3180 | |
| 10154971 | 2034-12-04 | U-2459 | |
| 10646456 | 2034-06-17 | U-2808 | |
| 8741343 | 2030-12-02 | U-2106 | |
| 9867791 | 2030-12-02 | U-2106 | |
| 9867792 | 2030-12-02 | U-2106 | |
| 9867793 | 2030-12-02 | U-2106 | |
| 9877933 | 2030-12-02 | U-2224 | |
| 11197835 | 2030-12-02 | U-2106 | |
| 8389578 | 2028-01-22 | U-219, U-2105, U-3054 | |
| 8796337 | 2025-11-23 | U-219, U-2106, U-2497, U-3054 | |
| 8889740 | 2025-11-23 | DP | |
| 8895614 | 2025-11-23 | DP | |
| 8895615 | 2025-11-23 | U-219, U-2106, U-3054 | |
| 8895616 | 2025-11-23 | U-219, U-2106, U-3054 | |
| 8895617 | 2025-11-23 | U-219, U-2106, U-3054 | |
| 8895618 | 2025-11-23 | DP | |
| Amantadine Hydrochloride, Osmolex Er, Adamas Operations | |||
| 10213393 | 2038-02-15 | U-20 | |
| 10213394 | 2038-02-15 | U-2497 | |
| 10500170 | 2038-02-15 | U-20 | |
| 10500171 | 2038-02-15 | U-2497 | |
| 10500172 | 2038-02-15 | U-2497 | |
| 10512617 | 2038-02-15 | U-2497 | |
| 8252331 | 2030-03-13 | DP | |
| 8574626 | 2025-11-28 | DP | U-20 |
| 8987333 | 2025-11-23 | DP | |
| 9072697 | 2025-11-23 | U-219, U-3054 | |

Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 3 | 6 | 11 | 24 | 3 | 46 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 8 | 10 | 9 | 8 | 36 |
| Cognitive dysfunction | D060825 | — | G31.84 | 2 | 11 | 9 | 4 | 2 | 25 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 3 | 4 | 5 | 7 | 18 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 3 | 3 | 8 | 3 | 17 |
| Brain injuries | D001930 | — | S06.9 | 1 | 4 | 3 | 5 | 7 | 17 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 2 | 5 | 7 | 3 | 1 | 16 |
| Dyskinesias | D020820 | — | G24 | 2 | 4 | 6 | 1 | 2 | 14 |
| Sclerosis | D012598 | — | — | — | 7 | 7 | 1 | — | 13 |
| Healthy volunteers/patients | — | — | — | 8 | 1 | — | 2 | 1 | 12 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | 3 | 4 | — | 1 | 9 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 5 | 4 | — | — | 9 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 3 | — | 2 | 6 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 5 | 2 | — | — | 5 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 5 | 2 | — | — | 5 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | 1 | 3 | 2 | — | — | 5 |
| Compulsive personality disorder | D003193 | — | F60.5 | 1 | 3 | 2 | — | — | 5 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | 2 | — | 2 | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 3 | 1 | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | 1 | — | — | 4 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Human influenza | D007251 | EFO_0007328 | J11.1 | 1 | 4 | — | — | 3 | 7 |
| Consciousness disorders | D003244 | — | — | 2 | 3 | — | — | — | 4 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 2 | — | — | 1 | 4 |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | — | 3 | — | — | 1 | 4 |
| Asperger syndrome | D020817 | EFO_0003757 | F84.5 | — | 3 | — | — | 1 | 4 |
| Tobacco use disorder | D014029 | — | F17 | 2 | 1 | — | — | — | 3 |
| Dyslexia | D004410 | EFO_0005424 | F81.0 | — | 3 | — | — | — | 3 |
| Coma | D003128 | — | R40.2 | — | 1 | — | — | 2 | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 3 | — | — | — | 3 |
| Post-acute covid-19 syndrome | D000094024 | — | — | — | 3 | — | — | — | 3 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 2 | — | — | — | — | 2 |
| Gliosarcoma | D018316 | — | — | 1 | — | — | — | — | 1 |
| Crush injuries | D000071576 | — | T14.8 | 1 | — | — | — | — | 1 |
| Central nervous system diseases | D002493 | — | G96.9 | 1 | — | — | — | — | 1 |
| Sleep deprivation | D012892 | — | F51.12 | 1 | — | — | — | — | 1 |
| Constipation | D003248 | — | K59.0 | 1 | — | — | — | — | 1 |
| Nervous system neoplasms | D009423 | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Subdural hematoma | D006408 | — | — | 1 | — | — | — | — | 1 |
| Hematoma | D006406 | EFO_0010680 | — | 1 | — | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Shy-drager syndrome | D012791 | EFO_1001050 | — | — | — | — | — | 1 | 1 |
| Multiple system atrophy | D019578 | — | — | — | — | — | — | 1 | 1 |
| Progressive supranuclear palsy | D013494 | EFO_0002512 | G23.1 | — | — | — | — | 1 | 1 |
| Corticobasal degeneration | D000088282 | — | G31.85 | — | — | — | — | 1 | 1 |
| Respiratory tract diseases | D012140 | — | — | — | — | — | — | 1 | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 1 | 1 |
| Drug common name | Amantadine |
| INN | amantadine |
| Description | Amantadine is a member of the class of adamantanes that is used as an antiviral and antiparkinson drug. It has a role as an antiviral drug, an antiparkinson drug, a dopaminergic agent, an analgesic, a NMDA receptor antagonist and a non-narcotic analgesic. It is a primary aliphatic amine and a member of adamantanes. It is a conjugate base of an adamantan-1-aminium. It derives from a hydride of an adamantane. |
| Classification | Small molecule |
| Drug class | antivirals/antiparkinsonians (adamantane derivatives) |
| Image (chem structure or protein) | ![]() |
| Structure (InChI/SMILES or Protein Sequence) | NC12CC3CC(CC(C3)C1)C2 |
| PDB | — |
| CAS-ID | 768-94-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL660 |
| ChEBI ID | 2618 |
| PubChem CID | 2130 |
| DrugBank | DB00915 |
| UNII ID | BF4C9Z1J53 (ChemIDplus, GSRS) |












