Details for New Drug Application (NDA): 212489
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NDA 212489 describes ONGENTYS, which is a drug marketed by Neurocrine and is included in one NDA. It is available from two suppliers. There are nine 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. Two suppliers are 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. Two suppliers are listed for this compound. Additional details are available on the opicapone profile page.
Summary for 212489
| Tradename: | ONGENTYS |
| Applicant: | Neurocrine |
| Ingredient: | opicapone |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212489
Generic Entry Date for 212489*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 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: | ⤷ Try a Trial | Patent Expiration: | Mar 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 27, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE | ||||||||
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