Details for New Drug Application (NDA): 208944
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NDA 208944 describes GOCOVRI, which is a drug marketed by Adamas Operations and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GOCOVRI profile page.
The generic ingredient in GOCOVRI is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
The generic ingredient in GOCOVRI is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 208944
| Tradename: | GOCOVRI |
| Applicant: | Adamas Operations |
| Ingredient: | amantadine hydrochloride |
| Patents: | 18 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208944
| Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 208944
Suppliers and Packaging for NDA: 208944
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944 | NDA | Adamas Pharma, LLC | 70482-085 | 70482-085-21 | 21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21) |
| GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944 | NDA | Adamas Pharma, LLC | 70482-085 | 70482-085-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 68.5MG BASE | ||||
| Approval Date: | Aug 24, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 24, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 4, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DYSKINESIA AND DECREASING OFF TIME IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 17, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS | ||||||||
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