Details for New Drug Application (NDA): 208944
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NDA 208944 describes GOCOVRI, which is a drug marketed by Supernus Pharms and is included in one NDA. It is available from two suppliers. 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. Thirty-five 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-five suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 208944
| Tradename: | GOCOVRI |
| Applicant: | Supernus Pharms |
| Ingredient: | amantadine hydrochloride |
| Patents: | 13 |
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 | Supernus Pharmaceuticals | 17772-085 | 17772-085-21 | 21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21) |
| GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944 | NDA | Supernus Pharmaceuticals | 17772-085 | 17772-085-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60) |
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 | |||||
| Patent: | 10,154,971 | 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: | 10,646,456 | 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 | ||||||||
| Patent: | 11,065,213 | Patent Expiration: | Aug 23, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 208944
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-002 | Aug 24, 2017 | 8,895,614 | ⤷ Get Started Free |
| Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-001 | Aug 24, 2017 | 8,796,337 | ⤷ Get Started Free |
| Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-001 | Aug 24, 2017 | 8,895,616 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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