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Last Updated: September 22, 2021

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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 one supplier. 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. One supplier is listed for this compound. Additional details are available on the opicapone profile page.
Summary for 212489
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 212489
Generic Entry Date for 212489*:
Constraining patent/regulatory exclusivity:

*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
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 Neurocrine Biosciences, Inc. 70370-3025 70370-3025-2 30 CAPSULE in 1 BOTTLE (70370-3025-2)
ONGENTYS opicapone CAPSULE;ORAL 212489 NDA Neurocrine Biosciences, Inc. 70370-3050 70370-3050-2 30 CAPSULE in 1 BOTTLE (70370-3050-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Apr 24, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 24, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Free Forever TrialPatent Expiration:Mar 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:May 27, 2035Product Flag?Substance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
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