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Last Updated: May 17, 2022

INREBIC Drug Patent 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 eighty-four patent family members in thirty-five 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 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:84
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 94
Clinical Trials: 3
Patent Applications: 405
Drug Prices: Drug price information for INREBIC
What excipients (inactive ingredients) are in INREBIC?INREBIC excipients list
DailyMed Link:INREBIC at DailyMed
Drug patent expirations by year for INREBIC
Drug Prices for INREBIC

See drug prices for INREBIC

DrugPatentWatch® Estimated 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.

Recent Clinical Trials for INREBIC

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

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

See all INREBIC clinical trials

US Patents and Regulatory Information for INREBIC

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INREBIC is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY MYELOFIBROSIS

Bi-aryl meta-pyrimidine inhibitors of kinases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Bi-aryl meta-pyrimidine inhibitors of kinases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of bi-aryl meta-pyrimidine inhibitors of kinases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 11323108
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013011184
Estimated Expiration: See Plans and Pricing

Canada

Patent: 16710
Estimated Expiration: See Plans and Pricing

Patent: 16957
Estimated Expiration: See Plans and Pricing

Chile

Patent: 13001252
Estimated Expiration: See Plans and Pricing

China

Patent: 3282036
Estimated Expiration: See Plans and Pricing

Patent: 8125923
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 01724
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 013000097
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 13012658
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 35282
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6101
Estimated Expiration: See Plans and Pricing

Japan

Patent: 33211
Estimated Expiration: See Plans and Pricing

Patent: 13541595
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 1164
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 0246
Estimated Expiration: See Plans and Pricing

Patent: 13005020
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 723
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1363
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1300038
Estimated Expiration: See Plans and Pricing

Peru

Patent: 140389
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 16262
Estimated Expiration: See Plans and Pricing

Patent: 13126121
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 0134
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1303423
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1940979
Estimated Expiration: See Plans and Pricing

Patent: 2131241
Estimated Expiration: See Plans and Pricing

Patent: 130137647
Estimated Expiration: See Plans and Pricing

Patent: 180122029
Estimated Expiration: See Plans and Pricing

Patent: 200083676
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 31389
Estimated Expiration: See Plans and Pricing

Patent: 1306882
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 13000195
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4076
Estimated Expiration: See Plans and Pricing

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
South Korea 101494468 See Plans and Pricing
Brazil PI0618179 inibidores de biaril meta pirimidina de cinases See Plans and Pricing
Ukraine 99899 БИАРИЛ-МЕТА-ПИРИМИДИНОВЫЕ ИНГИБИТОРЫ КИНАЗ;БІАРИЛ-МЕТА-ПІРИМІДИНОВІ ІНГІБІТОРИ КІНАЗ (BI-ARYL META-PYRIMIDINE INHIBITORS OF KINASES) See Plans and Pricing
>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 See Plans and Pricing 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 CA 2021 00011 Denmark See Plans and Pricing 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 LUC00204 Luxembourg See Plans and Pricing PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1514 20210209
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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AstraZeneca
McKinsey
Johnson and Johnson
Colorcon
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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.