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 ten 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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Summary for INREBIC
| International Patents: | 110 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 134 |
| Clinical Trials: | 4 |
| Patent Applications: | 352 |
| 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
*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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY MYELOFIBROSIS
Methods of treating myeloproliferative disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Bi-aryl meta-pyrimidine inhibitors of kinases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Use of bi-aryl meta-pyrimidine inhibitors of kinases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷ Sign Up
Patent: 11323108
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013011184
Patent: composições e métodos para tratamento de mielofibrose
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 16710
Patent: COMPOSITIONS ET METHODES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷ Sign Up
Patent: 16957
Patent: COMPOSITIONS ET PROCEDES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 13001252
Patent: Capsula para administracion oral que comprende n-terc-butil-3-[(5-metil-2-{[4-(2-pirrolidin-1-iletoxi)fenil]amino}pirimidin-4-il)amino]bencenosulfonamida, una celulosa microcristalina y estearil fumarato de sodio; forma de dosificacion unitaria; metodo para tratar mielofibrosis; metodo de preparacion; y articulo de preparacion.
Estimated Expiration: ⤷ Sign Up
China
Patent: 3282036
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷ Sign Up
Patent: 8125923
Patent: 用于治疗骨髓纤维化的组合物和方法 (Compositions and methods for treating myelofibrosis)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 01724
Patent: Composiciones y métodos para el tratamiento de la mielofibrosis
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0221269
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 35282
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 013000097
Patent: COMPOSICIONES Y MÉTODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 13012658
Patent: COMPOSICIONES Y MÉTODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 35282
Patent: COMPOSITIONS ET MÉTHODES DE TRAITEMENT DE LA MYÉLOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷ Sign Up
Patent: 59216
Patent: COMPOSITIONS DE TRAITEMENT DE LA MYÉLOFIBROSE (COMPOSITIONS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 60254
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6101
Patent: פורמולציות קפסולה של n-טרט-בוטיל-3-[(5 -מתיל-2-{[4-(2 -פירולידין-1-אילאתוקסי(פניל[אמינו{פירימידין-4-איל)אמינו]בנזינסולפונאמיד ושימוש בהן להכנת תרופות לטיפול במיאלופיברוזיס (Capsule formulations of n-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide and use thereof in the preparation of medicaments for treating myelofibrosis)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 33211
Estimated Expiration: ⤷ Sign Up
Patent: 13541595
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 35282
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 1164
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 0246
Patent: COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS. (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS.)
Estimated Expiration: ⤷ Sign Up
Patent: 13005020
Patent: COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS. (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 723
Patent: COMPOSITIONS ET MÉTHODES DE TRAITEMENT DE LA MYÉLOFIBROSE
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 1363
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1300038
Patent: COMPOSICIONES Y MÉTODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 140389
Patent: COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 35282
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 35282
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 16262
Patent: КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ МИЕЛОФИБРОЗА (COMPOSITIONS AND METHODS FOR MYELOFIBROSIS TREATMENT)
Estimated Expiration: ⤷ Sign Up
Patent: 13126121
Patent: КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ МИЕЛОФИБРОЗА
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 996
Patent: KOMPOZICIJE ZA LEČENJE MIJELOFIBROZE (COMPOSITIONS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 0134
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 35282
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1303423
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1940979
Estimated Expiration: ⤷ Sign Up
Patent: 2131241
Estimated Expiration: ⤷ Sign Up
Patent: 130137647
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷ Sign Up
Patent: 180122029
Patent: 골수 섬유증을 치료하기 위한 조성물 및 방법 (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷ Sign Up
Patent: 200083676
Patent: 골수 섬유증을 치료하기 위한 조성물 및 방법 (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷ Sign Up
Patent: 240029118
Patent: 골수 섬유증을 치료하기 위한 조성물 및 방법 (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 30650
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 31389
Estimated Expiration: ⤷ Sign Up
Patent: 1306882
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 13000195
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 4076
Patent: КОМПОЗИЦІЯ І СПОСІБ ЛІКУВАННЯ МІЄЛОФІБРОЗУ
Estimated Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | |
| South Africa | 200804083 | Bi-aryl meta-pyrimidine inhibitors of kinases | ⤷ Sign Up |
| European Patent Office | 4159216 | COMPOSITIONS DE TRAITEMENT DE LA MYÉLOFIBROSE (COMPOSITIONS FOR TREATING MYELOFIBROSIS) | ⤷ Sign Up |
| Brazil | PI0618179 | inibidores de biaril meta pirimidina de cinases | ⤷ Sign Up |
| Israel | 226101 | פורמולציות קפסולה של n-טרט-בוטיל-3-[(5 -מתיל-2-{[4-(2 -פירולידין-1-אילאתוקסי(פניל[אמינו{פירימידין-4-איל)אמינו]בנזינסולפונאמיד ושימוש בהן להכנת תרופות לטיפול במיאלופיברוזיס (Capsule formulations of n-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide and use thereof in the preparation of medicaments for treating myelofibrosis) | ⤷ Sign Up |
| Russian Federation | 2012103851 | БИ-АРИЛ-МЕТА-ПИРИМИДИНОВЫЕ ИНГИБИТОРЫ КИНАЗ | ⤷ Sign Up |
| Serbia | 63996 | KOMPOZICIJE ZA LEČENJE MIJELOFIBROZE (COMPOSITIONS FOR TREATING MYELOFIBROSIS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INREBIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1951684 | SPC/GB21/026 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; REGISTERED: UK EU/1/20/1514(FOR NI) 20210209; UK FURTHER MA ON IPSUM 20210209 |
| 1951684 | 122021000023 | Germany | ⤷ Sign Up | 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 | 14/2021 | Austria | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | CA 2021 00011 | Denmark | ⤷ Sign Up | 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 | CR 2021 00011 | Denmark | ⤷ Sign Up | 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 | C 2021 012 | Romania | ⤷ Sign Up | 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 |
| >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.
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