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
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 |


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
Sponsor | Phase |
---|---|
Bristol-Myers Squibb | Phase 2 |
H. Lee Moffitt Cancer Center and Research Institute | Phase 2 |
Bristol-Myers Squibb | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for INREBIC
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 |