Amantadine
Amantadine, Gocovri, Osmolex (amantadine) is a small molecule pharmaceutical. Amantadine was first approved as Symmetrel on 1982-01-01. It is used to treat drug-induced akathisia, drug-induced dyskinesia, dystonia, human influenza, and parkinson disease amongst others in the USA. The pharmaceutical is active against glutamate receptor ionotropic, NMDA 2A, glutamate receptor ionotropic, NMDA 2B, glutamate receptor ionotropic, NMDA 2D, and glutamate receptor ionotropic, NMDA 2C.
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Commercial
Trade Name
FDA
EMA
Gocovri, Osmolex (generic drugs available since 1986-08-05, discontinued: Symadine, Symmetrel)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amantadine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GOCOVRI | Adamas Pharmaceuticals | N-208944 RX | 2017-08-24 | 2 products, RLD, RS |
| OSMOLEX ER | Adamas Pharmaceuticals | N-209410 RX | 2018-02-16 | 2 products, RLD |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amantadine | ANDA | 2023-04-26 |
| amantadine hcl | ANDA | 2023-12-25 |
| amantadine hydrochloride | ANDA | 2024-01-09 |
| gocovri | New Drug Application | 2024-02-08 |
| osmolex er | New Drug Application | 2024-02-08 |
| symmetrel hard gel | ANDA | 2023-01-18 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMANTADINE HYDROCHLORIDE, GOCOVRI, ADAMAS OPERATIONS | |||
| 2024-08-24 | ODE-153 | ||
Patent Expiration
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 | |
HCPCS
No data
Clinical
Clinical Trials
104 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 6 | 8 | 5 | 5 | 25 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 1 | 1 | 3 | 4 | 9 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 1 | 4 | 1 | — | 6 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 1 | 2 | 1 | — | 5 |
| Cocaine-related disorders | D019970 | — | F14 | 1 | 3 | — | 1 | — | 5 |
| Parkinsonian disorders | D020734 | HP_0001300 | G20.C | — | 1 | — | 1 | 1 | 3 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | — | 1 | 1 | — | 3 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 1 | — | 1 | — | 3 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 2 | — | 2 |
| Delirium | D003693 | — | R41.0 | — | — | — | 2 | — | 2 |
Show 12 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyskinesias | D020820 | HP_0002310 | G24 | 1 | 2 | 6 | — | — | 8 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 3 | — | 2 | 6 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | 4 | — | — | 5 |
| Recurrence | D012008 | — | — | — | 1 | 2 | — | — | 2 |
| Hepatitis c | D006526 | — | B19.2 | — | 1 | 2 | — | — | 2 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | 1 | — | 1 | 2 |
| Cerebral infarction | D002544 | — | I63 | — | 1 | 1 | — | — | 1 |
| Rhinosinusitis | D000096825 | — | — | — | — | 1 | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | — | — | 1 | — | — | 1 |
| Spinal curvatures | D013121 | — | M43.9 | — | 1 | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Human influenza | D007251 | EFO_0007328 | J11.1 | 1 | 4 | — | — | 2 | 6 |
| Coma | D003128 | HP_0001259 | R40.2 | — | 1 | — | — | 2 | 3 |
| Huntington disease | D006816 | Orphanet_399 | G10 | — | 1 | — | — | 1 | 2 |
| Consciousness disorders | D003244 | — | — | 1 | 1 | — | — | — | 2 |
| Brain injuries | D001930 | — | S06.9 | 1 | 1 | — | — | 1 | 2 |
| Movement disorders | D009069 | HP_0100022 | — | 1 | 1 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | 1 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Intratracheal intubation | D007442 | — | — | — | 1 | — | — | — | 1 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | — | 1 | — | — | — | 1 |
Show 9 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aggression | D000374 | EFO_0003015 | — | — | — | — | — | 2 | 2 |
| Multiple system atrophy | D019578 | — | — | — | — | — | — | 1 | 1 |
| Neurologic gait disorders | D020233 | HP_0003376 | R26.1 | — | — | — | — | 1 | 1 |
| Progressive supranuclear palsy | D013494 | EFO_0002512 | G23.1 | — | — | — | — | 1 | 1 |
| Corticobasal degeneration | D000088282 | — | G31.85 | — | — | — | — | 1 | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 1 | 1 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | — | — | — | 1 | 1 |
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| 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 |
Identifiers
| PDB | — |
| CAS-ID | 768-94-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL660 |
| ChEBI ID | 2618 |
| PubChem CID | 2130 |
| DrugBank | DB00915 |
| UNII ID | BF4C9Z1J53 (ChemIDplus, GSRS) |
Target
Agency Approved
GRIN2B
GRIN2B
Organism
Homo sapiens
Gene name
GRIN2B
Gene synonyms
NMDAR2B
NCBI Gene ID
Protein name
glutamate receptor ionotropic, NMDA 2B
Protein synonyms
GluN2B(alt_5'UTR), Glutamate [NMDA] receptor subunit epsilon-2, glutamate receptor subunit epsilon-2, glutamate receptor, ionotropic, N-methyl D-aspartate 2B, hNR3, N-methyl D-aspartate receptor subtype 2B, N-methyl-D-aspartate receptor subunit 3, NMDAR2B, NR2B, NR3
Uniprot ID
Mouse ortholog
Grin2b (14812)
glutamate receptor ionotropic, NMDA 2B (Q01097)
Alternate
No data
Variants
No data
Financial
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Osmolex – RVL Pharmaceuticals
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Osmolex – Supernus Pharmaceuticals
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Gocovri – Supernus Pharmaceuticals
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Estimated US medical usage
Amantadine
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Trends
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Safety
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Adverse Events
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4,550 adverse events reported
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