IBRUTINIB Drug Patent Profile
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When do Ibrutinib patents expire, and what generic alternatives are available?
Ibrutinib is a drug marketed by Zydus and is included in one NDA.
The generic ingredient in IBRUTINIB 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.
Summary for IBRUTINIB
Recent Clinical Trials for IBRUTINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pharmacyclics LLC. | Phase 2/Phase 3 |
| Janssen Research & Development, LLC | Phase 2/Phase 3 |
| LanZhou University | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for IBRUTINIB
Paragraph IV (Patent) Challenges for IBRUTINIB
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| IMBRUVICA | Capsules | ibrutinib | 70 mg | 205552 | 1 | 2018-12-14 |
| IMBRUVICA | Tablets | ibrutinib | 280 mg and 420 mg | 210563 | 1 | 2018-12-14 |
| IMBRUVICA | Tablets | ibrutinib | 140 mg and 560 mg | 210563 | 1 | 2018-11-05 |
| IMBRUVICA | Capsules | ibrutinib | 140 mg | 205552 | 8 | 2017-11-13 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus | IBRUTINIB | ibrutinib | CAPSULE;ORAL | 211344-001 | Mar 31, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zydus | IBRUTINIB | ibrutinib | CAPSULE;ORAL | 211344-002 | Mar 31, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for IBRUTINIB
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Janssen-Cilag International NV | Imbruvica | ibrutinib | EMEA/H/C/003791 IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM. |
Authorised | no | no | no | 2014-10-21 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
