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IBRUTINIB - Generic Drug Details
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What are the generic drug sources for ibrutinib and what is the scope of freedom to operate?
Ibrutinib
is the generic ingredient in one branded drug marketed by Pharmacyclics Inc and is included in two NDAs. There are thirty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ibrutinib has two hundred and ninety-six patent family members in forty-one countries.
There are sixteen drug master file entries for ibrutinib. One supplier is listed for this compound.
Summary for IBRUTINIB
| International Patents: | 296 |
| US Patents: | 39 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 16 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 74 |
| Clinical Trials: | 309 |
| Patent Applications: | 2,971 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IBRUTINIB |
| DailyMed Link: | IBRUTINIB at DailyMed |
Recent Clinical Trials for IBRUTINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sobi | Phase 1 |
| Dr. David Spaner | Phase 1 |
| Loxo Oncology, Inc. | Phase 3 |
Pharmacology for IBRUTINIB
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
US Patents and Regulatory Information for IBRUTINIB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-004 | Feb 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-003 | Feb 16, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-004 | Feb 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-001 | Feb 16, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 IBRUTINIB
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2526933 | Start Trial |
| New Zealand | 604040 | Start Trial |
| Australia | 2013271918 | Start Trial |
| Colombia | 7240408 | Start Trial |
| China | 111265531 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for IBRUTINIB
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2201840 | C20150014 00145 | Estonia | Start Trial | PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014 |
| 2529621 | C20170010 00272 | Estonia | Start Trial | PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014 |
| 2201840 | 122015000027 | Germany | Start Trial | PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 2201840 | PA2015017,C2201840 | Lithuania | Start Trial | PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 2201840 | 233 5006-2015 | Slovakia | Start Trial | PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023 |
| >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.
ISSN: 2162-2639
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