Details for New Drug Application (NDA): 202834
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The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the perampanel profile page.
Summary for 202834
| Tradename: | FYCOMPA |
| Applicant: | Catalyst Pharms |
| Ingredient: | perampanel |
| Patents: | 2 |
Suppliers and Packaging for NDA: 202834
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FYCOMPA | perampanel | TABLET;ORAL | 202834 | NDA | Eisai Inc. | 62856-272 | 62856-272-14 | 14 TABLET in 1 PACKET (62856-272-14) |
| FYCOMPA | perampanel | TABLET;ORAL | 202834 | NDA | Eisai Inc. | 62856-272 | 62856-272-30 | 30 TABLET in 1 BOTTLE (62856-272-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Oct 22, 2012 | TE: | AB | RLD: | Yes | ||||
| Patent: | 6,949,571 | Patent Expiration: | May 23, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF EPILEPSY | ||||||||
| Patent: | 6,949,571 | Patent Expiration: | May 23, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY | ||||||||
| Patent: | 6,949,571 | Patent Expiration: | May 23, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY 4 YEARS OF AGE AND OLDER | ||||||||
Expired US Patents for NDA 202834
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-005 | Oct 22, 2012 | 6,949,571 | ⤷ Get Started Free |
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-001 | Oct 22, 2012 | 6,949,571 | ⤷ Get Started Free |
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-006 | Oct 22, 2012 | 6,949,571 | ⤷ Get Started Free |
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-004 | Oct 22, 2012 | 6,949,571 | ⤷ Get Started Free |
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-002 | Oct 22, 2012 | 6,949,571 | ⤷ Get Started Free |
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-003 | Oct 22, 2012 | 6,949,571 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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