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 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
Summary for INREBIC
International Patents: | 109 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 134 |
Clinical Trials: | 4 |
Patent Applications: | 489 |
Drug Prices: | Drug price information for INREBIC |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INREBIC |
What excipients (inactive ingredients) are in INREBIC? | INREBIC excipients list |
DailyMed Link: | INREBIC at DailyMed |
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
Sponsor | Phase |
---|---|
Bristol-Myers Squibb | Phase 1 |
Joseph Jurcic | Phase 1 |
Bristol-Myers Squibb | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for INREBIC
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
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 |
---|---|---|---|
South Korea | 20130100380 | BI-ARYL META-PYRIMIDINE INHIBITORS OF KINASES | ⤷ Try a Trial |
Lithuania | 2635282 | ⤷ Try a Trial | |
Spain | 2595636 | ⤷ Try a Trial | |
South Korea | 102131241 | ⤷ Try a Trial | |
South Korea | 20080066066 | BI-ARYL META-PYRIMIDINE INHIBITORS OF KINASES | ⤷ Try a Trial |
Denmark | 1951684 | ⤷ Try a Trial | |
Australia | 2019346521 | Methods of treating myeloproliferative disorders | ⤷ 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 | 14/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: FEDRATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN PHARMAZEUTISCH ANNEHMBARES HYDRAT DAVON, INSBESONDERE FEDRATINIB-DIHYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/20/1514 (MITTEILUNG) 20210209 |
1951684 | LUC00204 | Luxembourg | ⤷ Try a Trial | 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 | 122021000023 | Germany | ⤷ Try a Trial | PRODUCT NAME: FEDRATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER EIN PHARMAZEUTISCH UNBEDENKLICHES HYDRAT DAVON, INSBESONDERE FEDRATINIB-DIHYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/20/1514 20210208 |
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 | C01951684/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021 |
1951684 | CA 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |