Details for New Drug Application (NDA): 208078
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The generic ingredient in FIRDAPSE is amifampridine phosphate. One supplier is listed for this compound. Additional details are available on the amifampridine phosphate profile page.
Summary for 208078
Tradename: | FIRDAPSE |
Applicant: | Catalyst Pharms |
Ingredient: | amifampridine phosphate |
Patents: | 5 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208078
Generic Entry Date for 208078*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) IN ADULTS Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 208078
Mechanism of Action | Potassium Channel Antagonists |
Suppliers and Packaging for NDA: 208078
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078 | NDA | Catalyst Pharmaceuticals, Inc. | 69616-211 | 69616-211-03 | 240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03) |
FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078 | NDA | Catalyst Pharmaceuticals, Inc. | 69616-211 | 69616-211-06 | 12 BLISTER PACK in 1 CARTON (69616-211-06) > 10 TABLET in 1 BLISTER PACK (69616-211-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Nov 28, 2018 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Nov 28, 2025 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) IN ADULTS | ||||||||
Regulatory Exclusivity Expiration: | Nov 28, 2023 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | Apr 7, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE |
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