DrugPatentWatch Database Preview
IMBRUVICA Drug Profile
» See Plans and Pricing
When do Imbruvica patents expire, and when can generic versions of Imbruvica launch?
Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. There are thirty-four patents protecting this drug and four Paragraph IV challenges.
This drug has two hundred and ninety-one patent family members in forty-one countries.
The generic ingredient in IMBRUVICA is ibrutinib. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
US ANDA Litigation and Generic Entry Outlook for Imbruvica
Imbruvica was eligible for patent challenges on November 13, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 30, 2033. This may change due to patent challenges or generic licensing.
There have been ten patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for IMBRUVICA
| International Patents: | 291 |
| US Patents: | 34 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 125 |
| Patent Applications: | 373 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for IMBRUVICA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IMBRUVICA |
| DailyMed Link: | IMBRUVICA at DailyMed |
Generic Entry Opportunity Date for IMBRUVICA
Generic Entry Dates for IMBRUVICA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for IMBRUVICA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 IMBRUVICA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute, France | Phase 1/Phase 2 |
| Institut Curie | Phase 1/Phase 2 |
| Joseph Tuscano | Phase 2 |
Pharmacology for IMBRUVICA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
US Patents and Regulatory Information for IMBRUVICA
| 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 | 210563-003 | Feb 16, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-002 | Feb 16, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-004 | Feb 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-002 | 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 | Y | Y | 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 IMBRUVICA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 2526771 | Start Trial |
| South Korea | 101580714 | Start Trial |
| Brazil | PI0622277 | Start Trial |
| Hungary | E033182 | Start Trial |
| European Patent Office | 2532234 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for IMBRUVICA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2201840 | PA2015017,C2201840 | Lithuania | Start Trial | PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 2526934 | CA 2016 00056 | Denmark | Start Trial | PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530 |
| 2201840 | 2015/020 | Ireland | Start Trial | PRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 2201840 | 92692 | Luxembourg | Start Trial | PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023 |
| 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 |
