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Last Updated: April 22, 2024

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INREBIC Drug Patent Profile


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

Inrebic is a drug marketed by Bristol-myers and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nine patent family members in forty 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.

DrugPatentWatch® Generic Entry Outlook for Inrebic

Inrebic was eligible for patent challenges on August 16, 2023.

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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for INREBIC
Drug Prices for INREBIC

See drug prices for INREBIC

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for INREBIC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Joseph JurcicPhase 1
Bristol-Myers SquibbPhase 1
H. Lee Moffitt Cancer Center and Research InstitutePhase 2

See all INREBIC clinical trials

Paragraph IV (Patent) Challenges for INREBIC
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INREBIC Capsules fedratinib hydrochloride 100 mg 212327 1 2023-08-16

US Patents and Regulatory Information for INREBIC

INREBIC is protected by five US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INREBIC is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting INREBIC

Compositions and methods for treating myelofibrosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY MYELOFIBROSIS

Methods of treating myeloproliferative disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

Bi-aryl meta-pyrimidine inhibitors of kinases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Bi-aryl meta-pyrimidine inhibitors of kinases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Use of bi-aryl meta-pyrimidine inhibitors of kinases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY MYELOFIBROSIS

FDA Regulatory Exclusivity protecting INREBIC

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)
Exclusivity Expiration: ⤷  Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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

International Patents for INREBIC

When does loss-of-exclusivity occur for INREBIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 10363329
Estimated Expiration: ⤷  Try a Trial

Patent: 11323108
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013011184
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 16710
Estimated Expiration: ⤷  Try a Trial

Patent: 16957
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 13001252
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3282036
Estimated Expiration: ⤷  Try a Trial

Patent: 8125923
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 01724
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0221269
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 35282
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 013000097
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 13012658
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 35282
Estimated Expiration: ⤷  Try a Trial

Patent: 59216
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 60254
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6101
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 33211
Estimated Expiration: ⤷  Try a Trial

Patent: 13541595
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 35282
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 1164
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 0246
Estimated Expiration: ⤷  Try a Trial

Patent: 13005020
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 723
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1363
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1300038
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 140389
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 35282
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 35282
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 16262
Estimated Expiration: ⤷  Try a Trial

Patent: 13126121
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 996
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 0134
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 35282
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1303423
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1940979
Estimated Expiration: ⤷  Try a Trial

Patent: 2131241
Estimated Expiration: ⤷  Try a Trial

Patent: 130137647
Estimated Expiration: ⤷  Try a Trial

Patent: 180122029
Estimated Expiration: ⤷  Try a Trial

Patent: 200083676
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 30650
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 31389
Estimated Expiration: ⤷  Try a Trial

Patent: 1306882
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 13000195
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 4076
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INREBIC around the world.

Country Patent Number Title Estimated Expiration
Lithuania PA2021509 ⤷  Try a Trial
Singapore 190134 COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS ⤷  Try a Trial
South Korea 20130137647 COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS ⤷  Try a Trial
Lithuania 1951684 ⤷  Try a Trial
China 101370792 Bi-aryl meta-pyrimidine inhibitors of kinases ⤷  Try a Trial
Taiwan I531389 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INREBIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1951684 CR 2021 00011 Denmark ⤷  Try a Trial PRODUCT NAME: FEDRATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET FARMACEUTISK ACCEPTABELT HYDRAT DERAF, ISAER FEDRATINIB-DIHYDROCHLORIDMONOHYDRAT; REG. NO/DATE: EU/1/20/1514 20210209
1951684 PA2021509,C1951684 Lithuania ⤷  Try a Trial PRODUCT NAME: FEDRATINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA FARMACINIU POZIURIU PRIIMTINAS JO HIDRATAS, YPAC FEDRATINIBO DIHIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/20/1514 20210208
1951684 301104 Netherlands ⤷  Try a Trial PRODUCT NAME: FEDRATINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, OF EEN FARMACEUTISCH AANVAARDBAAR HYDRAAT DAARVAN, IN HET BIJZONDER FEDRATINIBDIHYDROCHLORIDEMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/20/1514 20210209
1951684 2021C/513 Belgium ⤷  Try a Trial PRODUCT NAME: FEDRATINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN HYDRATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE DICHLORHYDRATE DE FEDRATINIB MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1514 20210209
1951684 21C1019 France ⤷  Try a Trial PRODUCT NAME: FEDRATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN HYDRATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE DICHLORHYDRATE DE FEDRATINIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/20/1514 20210209
1951684 2190016-2 Sweden ⤷  Try a Trial PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; REG. NO/DATE: EU/1/20/1514 20210209
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.