Details for New Drug Application (NDA): 212327
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NDA 212327 describes INREBIC, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the INREBIC profile page.
The generic ingredient in INREBIC is fedratinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fedratinib hydrochloride profile page.
The generic ingredient in INREBIC is fedratinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fedratinib hydrochloride profile page.
Summary for 212327
| Tradename: | INREBIC |
| Applicant: | Bristol-myers |
| Ingredient: | fedratinib hydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212327
Generic Entry Date for 212327*:
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.
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: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Aug 16, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 16, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY (POST-POLYCYTHEMIA VERA OR POST-ESSENTIAL THROMBOCYTHEMIA) MYELOFIBROSIS (MF) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 4, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY MYELOFIBROSIS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 24, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING ADULT PATIENTS WITH INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY MYELOFIBROSIS, MONITORING THIAMINE LEVELS AND ADMINISTERING THIAMINE OR A THIAMINE EQUIVALENT | ||||||||
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