Details for New Drug Application (NDA): 212489
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NDA 212489 describes ONGENTYS, which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ONGENTYS profile page.
The generic ingredient in ONGENTYS is opicapone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the opicapone profile page.
The generic ingredient in ONGENTYS is opicapone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the opicapone profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212489
*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: 212489
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Suppliers and Packaging for NDA: 212489
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONGENTYS | opicapone | CAPSULE;ORAL | 212489 | NDA | Amneal Pharmaceuticals LLC | 64896-402 | 64896-402-01 | 30 CAPSULE in 1 BOTTLE (64896-402-01) |
| ONGENTYS | opicapone | CAPSULE;ORAL | 212489 | NDA | Amneal Pharmaceuticals LLC | 64896-403 | 64896-403-01 | 30 CAPSULE in 1 BOTTLE (64896-403-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Apr 24, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 31, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING OFF EPISODES | ||||||||
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