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Last Updated: August 14, 2020

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INREBIC Drug Profile

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Which patents cover Inrebic, and what generic alternatives are available?

Inrebic is a drug marketed by Impact and is included in one NDA. There are four patents protecting this drug.

This drug has seventy-seven patent family members in thirty-four countries.

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.

US ANDA Litigation and Generic Entry Outlook for Inrebic

Inrebic will be eligible for patent challenges on August 16, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 4, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for INREBIC
International Patents:77
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 81
Patent Applications: 62
Drug Prices: Drug price information for INREBIC
DailyMed Link:INREBIC at DailyMed
Drug patent expirations by year for INREBIC
Drug Prices for INREBIC

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Generic Entry Opportunity Date for INREBIC
Generic Entry Date for INREBIC*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for INREBIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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