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Last Updated: December 2, 2020

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Details for New Drug Application (NDA): 212327

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NDA 212327 describes INREBIC, which is a drug marketed by Impact and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the INREBIC profile page.

The generic ingredient in INREBIC is fedratinib hydrochloride. One supplier is listed for this compound. Additional details are available on the fedratinib hydrochloride profile page.
Summary for 212327
Ingredient:fedratinib hydrochloride
Generic Entry Opportunity Date for 212327
Generic Entry Date for 212327*:
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.

Suppliers and Packaging for NDA: 212327
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327 NDA Celgene Corporation 59572-720 59572-720-12 120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Aug 16, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 16, 2024
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Aug 16, 2026
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Jun 4, 2032Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Johnson and Johnson
Boehringer Ingelheim

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