IMBRUVICA Drug Patent Profile
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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 forty patents protecting this drug and four Paragraph IV challenges.
This drug has three hundred and thirty-one patent family members in forty-three 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.
DrugPatentWatch® Generic Entry Outlook for Imbruvica
Imbruvica was eligible for patent challenges on November 13, 2017.
There have been eleven 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.
There are five tentative approvals for the generic drug (ibrutinib), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for IMBRUVICA
| International Patents: | 331 |
| US Patents: | 40 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 148 |
| Patent Applications: | 450 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for IMBRUVICA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IMBRUVICA |
| What excipients (inactive ingredients) are in IMBRUVICA? | IMBRUVICA excipients list |
| DailyMed Link: | IMBRUVICA at DailyMed |
Recent Clinical Trials for IMBRUVICA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Academic and Community Cancer Research United | Phase 2 |
| Loxo Oncology, Inc. | Phase 3 |
| Joseph Tuscano | Phase 2 |
Pharmacology for IMBRUVICA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for IMBRUVICA
Paragraph IV (Patent) Challenges for IMBRUVICA
| 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 IMBRUVICA
IMBRUVICA is protected by eighty-nine US patents and six FDA Regulatory Exclusivities.
Patents protecting IMBRUVICA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods of treating and preventing graft versus host disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA
Methods of treating and preventing graft versus host disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
Crystalline forms of a brutons tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC SMALL LYMPHOCYTIC LEUKEMIA
Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
Inhibitors of bruton'S tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA
Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LEUKEMIA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods of treating and preventing graft versus host disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
Methods of treating and preventing graft versus host disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CYCLOSPORIN-RESISTANT, STEROID-DEPENDENT/REFRACTORY, OR STEROID RESISTANT CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
Methods of treating and preventing graft versus host disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
Use of inhibitors of bruton'S tyrosine kinase (BTK)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA
FDA Regulatory Exclusivity protecting IMBRUVICA
INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF PATIENTS WITH MARGINAL ZONE LYMPHOMA (MZL) WHO REQUIRE SYSTEMIC THERAPY AND HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED THERAPY
Exclusivity Expiration: See Plans and Pricing
INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITHOUT 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE THERAPY)
Exclusivity Expiration: See Plans and Pricing
FOR TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD)
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-002 | Feb 16, 2018 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 IMBRUVICA
| 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 is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).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.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 obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).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 |
International Patents for IMBRUVICA
When does loss-of-exclusivity occur for IMBRUVICA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2844
Estimated Expiration: See Plans and Pricing
Patent: 3832
Estimated Expiration: See Plans and Pricing
Patent: 8108
Estimated Expiration: See Plans and Pricing
Australia
Patent: 13271918
Estimated Expiration: See Plans and Pricing
Patent: 16226279
Estimated Expiration: See Plans and Pricing
Patent: 16250445
Estimated Expiration: See Plans and Pricing
Patent: 18211201
Estimated Expiration: See Plans and Pricing
Patent: 18211216
Estimated Expiration: See Plans and Pricing
Patent: 20239751
Estimated Expiration: See Plans and Pricing
Patent: 21240244
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2014030424
Estimated Expiration: See Plans and Pricing
Patent: 2017018931
Estimated Expiration: See Plans and Pricing
Canada
Patent: 75986
Estimated Expiration: See Plans and Pricing
Patent: 76695
Estimated Expiration: See Plans and Pricing
Patent: 91994
Estimated Expiration: See Plans and Pricing
Patent: 15208
Estimated Expiration: See Plans and Pricing
Chile
Patent: 14003306
Estimated Expiration: See Plans and Pricing
Patent: 17000371
Estimated Expiration: See Plans and Pricing
Patent: 17003496
Estimated Expiration: See Plans and Pricing
China
Patent: 4736178
Estimated Expiration: See Plans and Pricing
Patent: 7427498
Estimated Expiration: See Plans and Pricing
Patent: 0354132
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 40408
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 140558
Estimated Expiration: See Plans and Pricing
Dominican Republic
Patent: 014000274
Estimated Expiration: See Plans and Pricing
Patent: 017000152
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 14033163
Estimated Expiration: See Plans and Pricing
Patent: 19015794
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 1492082
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 54859
Estimated Expiration: See Plans and Pricing
Patent: 65084
Estimated Expiration: See Plans and Pricing
Guatemala
Patent: 1400281
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 08803
Estimated Expiration: See Plans and Pricing
Patent: 49015
Estimated Expiration: See Plans and Pricing
Israel
Patent: 5894
Estimated Expiration: See Plans and Pricing
Patent: 3995
Estimated Expiration: See Plans and Pricing
Patent: 4739
Estimated Expiration: See Plans and Pricing
Patent: 2367
Estimated Expiration: See Plans and Pricing
Japan
Patent: 36071
Estimated Expiration: See Plans and Pricing
Patent: 37086
Estimated Expiration: See Plans and Pricing
Patent: 15518885
Estimated Expiration: See Plans and Pricing
Patent: 18012710
Estimated Expiration: See Plans and Pricing
Patent: 18048182
Estimated Expiration: See Plans and Pricing
Patent: 18507200
Estimated Expiration: See Plans and Pricing
Patent: 19203008
Estimated Expiration: See Plans and Pricing
Patent: 20015744
Estimated Expiration: See Plans and Pricing
Patent: 21183617
Estimated Expiration: See Plans and Pricing
Patent: 21193095
Estimated Expiration: See Plans and Pricing
Jordan
Patent: 0200222
Estimated Expiration: See Plans and Pricing
Patent: 54
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 7999
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 8290
Estimated Expiration: See Plans and Pricing
Patent: 14014848
Estimated Expiration: See Plans and Pricing
Patent: 17011270
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 711
Estimated Expiration: See Plans and Pricing
Patent: 643
Estimated Expiration: See Plans and Pricing
Patent: 654
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 2548
Estimated Expiration: See Plans and Pricing
Patent: 3828
Estimated Expiration: See Plans and Pricing
Patent: 1932
Estimated Expiration: See Plans and Pricing
Patent: 7725
Estimated Expiration: See Plans and Pricing
Peru
Patent: 150174
Estimated Expiration: See Plans and Pricing
Patent: 190390
Estimated Expiration: See Plans and Pricing
Philippines
Patent: 014502681
Estimated Expiration: See Plans and Pricing
Patent: 020500028
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 17133990
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 202101389T
Estimated Expiration: See Plans and Pricing
Patent: 202102078V
Estimated Expiration: See Plans and Pricing
Patent: 201408067Y
Estimated Expiration: See Plans and Pricing
Patent: 201707122Q
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 150015021
Estimated Expiration: See Plans and Pricing
Patent: 170091785
Estimated Expiration: See Plans and Pricing
Patent: 170122220
Estimated Expiration: See Plans and Pricing
Patent: 190040370
Estimated Expiration: See Plans and Pricing
Patent: 200017549
Estimated Expiration: See Plans and Pricing
Patent: 210033067
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 32912
Estimated Expiration: See Plans and Pricing
Patent: 53041
Estimated Expiration: See Plans and Pricing
Patent: 62963
Estimated Expiration: See Plans and Pricing
Patent: 62964
Estimated Expiration: See Plans and Pricing
Patent: 33027
Estimated Expiration: See Plans and Pricing
Patent: 1402122
Estimated Expiration: See Plans and Pricing
Patent: 1636023
Estimated Expiration: See Plans and Pricing
Patent: 1811334
Estimated Expiration: See Plans and Pricing
Patent: 1902483
Estimated Expiration: See Plans and Pricing
Patent: 1906612
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 14000492
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 4421
Estimated Expiration: See Plans and Pricing
Uruguay
Patent: 848
Estimated Expiration: See Plans and Pricing
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 IMBRUVICA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Uruguay | 34848 | FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON | See Plans and Pricing |
| Hong Kong | 1140107 | INHIBITORS OF BRUTON'S TYROSINE KINASE BRUTON | See Plans and Pricing |
| Canada | 2874756 | INHIBITEURS DE LA TYROSINE KINASE DE BRUTON (INHIBITORS OF BRUTON'S TYROSINE KINASE) | See Plans and Pricing |
| Hong Kong | 1249015 | 布魯頓氏酪氨酸激酶抑制劑的醫藥配方 (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IMBRUVICA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2201840 | 18/2015 | Austria | See Plans and Pricing | PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 2529621 | LUC00011 | Luxembourg | See Plans and Pricing | PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 20150707 |
| 2201840 | 122015000027 | Germany | See Plans and Pricing | PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 2201840 | CR 2015 00021 | Denmark | See Plans and Pricing | PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. 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.
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