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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 patent protection?
Ibrutinib
is the generic ingredient in one branded drug marketed by Pharmacyclics Inc and is included in two NDAs. There are thirty-eight 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.
Summary for ibrutinib
| International Patents: | 296 |
| US Patents: | 38 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 16 |
| Bulk Api Vendors: | 74 |
| Clinical Trials: | 302 |
| 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 |
|---|---|
| Huiqiang Huang | Phase 2 |
| Nanfang Hospital of Southern Medical University | Phase 2 |
| Karyopharm Therapeutics Inc | Phase 1/Phase 2 |
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 | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-002 | Dec 20, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-003 | Feb 16, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | Start Trial | Start Trial | 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 | 210563-004 | Feb 16, 2018 | 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 |
|---|---|---|
| Spain | 2562215 | Start Trial |
| China | 102887900 | Start Trial |
| Portugal | 2529622 | Start Trial |
| Canada | 2681756 | Start Trial |
| Australia | 2013271918 | Start Trial |
| Costa Rica | 20140558 | Start Trial |
| South Korea | 101425248 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ibrutinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2201840 | 122015000027 | Germany | Start Trial | PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 2526934 | 132016000119245 | Italy | Start Trial | PRODUCT NAME: IBRUTINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE PER IL TRATTAMENTO DI PAZIENTI ADULTI CON LEUCEMIA LINFOCITICA CRONICA (CLL) PRECEDENTEMENTE NON TRATTATA(IMBRUVICA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/945, 20160530 |
| 2201840 | PA2015017,C2201840 | Lithuania | Start Trial | PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 2529621 | CA 2017 00012 | Denmark | Start Trial | PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2015)4704 20150707 |
| 2201840 | 300728 | Netherlands | Start Trial | DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN |
| 2529621 | 132017000036530 | Italy | Start Trial | PRODUCT NAME: IBRUTINIB O SUO SALE FARMACEUTICAMENTE ACCETTABILE(IMBRUVICA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/4/945, 20150707 |
| 2201840 | C300728 | Netherlands | Start Trial | PRODUCT NAME: IBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
