INREBIC Drug Patent Profile

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 five patents protecting this drug.

This drug has one hundred and five patent family members in thirty-eight 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

Summary for INREBIC

International Patents:	105
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	604
Drug Prices:	Drug price information for INREBIC
What excipients (inactive ingredients) are in INREBIC?	INREBIC excipients list
DailyMed Link:	INREBIC at DailyMed

See drug prices for INREBIC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INREBIC

NDA:

212327

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

Sponsor	Phase
Joseph Jurcic	Phase 1
Bristol-Myers Squibb	Phase 1
H. Lee Moffitt Cancer Center and Research Institute	Phase 2

See all INREBIC clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for INREBIC

L01EJ	Janus-associated kinase (JAK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for INREBIC

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

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

FDA Regulatory Exclusivity protecting 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			Y
Impact	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes
Impact	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes				Y
Impact	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes
Impact	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes
Impact	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes

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

Brazil

Canada

Chile

China

Colombia

Croatia

Denmark

Dominican Republic

Ecuador

European Patent Office

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Peru

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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
Russian Federation	2013126121	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ МИЕЛОФИБРОЗА
Mexico	2021003450	METODOS PARA TRATAR TRASTORNOS MIELOPROLIFERATIVOS. (METHODS OF TREATING MYELOPROLIFERATIVE DISORDERS.)
Mexico	362412	INHIBIDORES DE BIARIL META-PIRIMIDINA DE CINASAS. (BI-ARYL META-PYRIMIDINE INHIBITORS OF KINASES.)
Singapore	11202103019W	METHODS OF TREATING MYELOPROLIFERATIVE DISORDERS
Australia	2019346521	Methods of treating myeloproliferative disorders
Taiwan	I444368

Supplementary Protection Certificates for INREBIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1951684	2190016-2	Sweden		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
1951684	2021C/513	Belgium		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	LUC00204	Luxembourg		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
1951684	21C1019	France		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	C01951684/01	Switzerland		PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021
1951684	C 2021 012	Romania		PRODUCT NAME: FEDRATINIB, SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, SAU UN HIDRAT ACCEPTABIL FARMACEUTIC AL ACESTUIA, IN PARTICULAR DICLORHIDRAT DE FEDRATINIB MONOHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/20/1514; DATE OF NATIONAL AUTHORISATION: 20210208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1514; DATE OF FIRST AUTHORISATION IN EEA: 20210208