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Generated: November 20, 2018

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Details for New Drug Application (NDA): 208944

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NDA 208944 describes GOCOVRI, which is a drug marketed by Adamas Pharma and is included in one NDA. It is available from one supplier. There are thirteen 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. Forty-four suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 208944
Tradename:GOCOVRI
Applicant:Adamas Pharma
Ingredient:amantadine hydrochloride
Patents:13
Formulation / Manufacturing:see details
Pharmacology for NDA: 208944
Mechanism of ActionM2 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 70482-085-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-60)
GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944 NDA Adamas Pharma, LLC 70482-170 70482-170-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 68.5MG BASE
Approval Date:Aug 24, 2017TE: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
Regulatory Exclusivity Expiration:Aug 24, 2020
Regulatory Exclusivity Use:TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
Patent:➤ Sign UpPatent Expiration:Jan 22, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING IMMEDIATE RELEASE LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Daiichi Sankyo
Accenture
Colorcon
Cipla
Federal Trade Commission
McKinsey
US Army
Boehringer Ingelheim

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