Imbruvica is a drug owned by Pharmacyclics Llc. It is protected by 84 US drug patents filed from 2016 to 2026 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 14, 2039. Details of Imbruvica's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9296753 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Oct, 2033
(7 years from now) | Active |
| US10125140 | Crystalline forms of a bruton's tyrosine kinase inhibitor |
Jun, 2033
(6 years from now) | Active |
| US10106548 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(6 years from now) | Active |
| US9725455 | Crystalline forms of a bruton's tyrosine kinase inhibitor |
Jun, 2033
(6 years from now) | Active |
| US8008309 | Inhibitors of bruton's tyrosine kinase |
Nov, 2027
(1 year, 1 month from now) | Active |
| US8697711 | Inhibitors of bruton'S tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
| US9181257 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
| US8735403 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
| US8957079 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
| US7514444 | Inhibitors of bruton's tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12201690 | Formulations/compositions comprising ibrutinib |
Jun, 2039
(12 years from now) | Active |
|
US9655857 (Pediatric) | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Sep, 2036
(9 years from now) | Active |
|
US10010507 (Pediatric) | Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor |
Sep, 2036
(9 years from now) | Active |
|
US10828259 (Pediatric) | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Sep, 2036
(9 years from now) | Active |
|
US10213386 (Pediatric) | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Sep, 2036
(9 years from now) | Active |
| US12364698 | Compositions Containing Ibrutinib |
Apr, 2036
(9 years from now) | Active |
| US9655857 | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Mar, 2036
(9 years from now) | Active |
| US10010507 | Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor |
Mar, 2036
(9 years from now) | Active |
| US10828259 | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Mar, 2036
(9 years from now) | Active |
| US12551448 | Pharmaceutical Formulations Of A Bruton'S Tyrosine Kinase Inhibitor |
Mar, 2036
(9 years from now) | Active |
| US10213386 | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Mar, 2036
(9 years from now) | Active |
|
US9795604 (Pediatric) | Methods of treating and preventing graft versus host disease |
Apr, 2035
(8 years from now) | Active |
|
US10463668 (Pediatric) | Methods of treating and preventing graft versus host disease |
Apr, 2035
(8 years from now) | Active |
|
US10695350 (Pediatric) | Methods of treating and preventing graft versus host disease |
Apr, 2035
(8 years from now) | Active |
| US9795604 | Methods of treating and preventing graft versus host disease |
Oct, 2034
(8 years from now) | Active |
| US10695350 | Methods of treating and preventing graft versus host disease |
Oct, 2034
(8 years from now) | Active |
| US10463668 | Methods of treating and preventing graft versus host disease |
Oct, 2034
(8 years from now) | Active |
|
US9296753 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Apr, 2034
(7 years from now) | Active |
|
US9540382 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Feb, 2034
(7 years from now) | Active |
|
US10961251 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(7 years from now) | Active |
|
US10125140 (Pediatric) | Crystalline forms of a bruton's tyrosine kinase inhibitor |
Dec, 2033
(7 years from now) | Active |
|
US10106548 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(7 years from now) | Active |
|
US9713617 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(7 years from now) | Active |
|
US9725455 (Pediatric) | Crystalline forms of a bruton's tyrosine kinase inhibitor |
Dec, 2033
(7 years from now) | Active |
|
US10294231 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(7 years from now) | Active |
|
US10294232 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(7 years from now) | Active |
|
US10752634 (Pediatric) | Crystalline forms of a brutons tyrosine kinase inhibitor |
Dec, 2033
(7 years from now) | Active |
| US9540382 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Aug, 2033
(6 years from now) | Active |
| US10961251 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(6 years from now) | Active |
| US10294231 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(6 years from now) | Active |
| US10294232 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(6 years from now) | Active |
| US10752634 | Crystalline forms of a brutons tyrosine kinase inhibitor |
Jun, 2033
(6 years from now) | Active |
| US9713617 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(6 years from now) | Active |
|
US9814721 (Pediatric) | Use of inhibitors of bruton'S tyrosine kinase (BTK) |
Dec, 2031
(5 years from now) | Active |
|
US10653696 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (BTK) |
Dec, 2031
(5 years from now) | Active |
|
US8754090 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Dec, 2031
(5 years from now) | Active |
|
US9801881 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (BTK) |
Dec, 2031
(5 years from now) | Active |
|
US8999999 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(5 years from now) | Active |
|
US10478439 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Dec, 2031
(5 years from now) | Active |
|
US10016435 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(5 years from now) | Active |
|
US9125889 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(5 years from now) | Active |
|
US9801883 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Dec, 2031
(5 years from now) | Active |
|
US10751342 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(5 years from now) | Active |
|
US10004746 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(5 years from now) | Active |
| US9801881 | Use of inhibitors of bruton's tyrosine kinase (BTK) |
Jun, 2031
(4 years from now) | Active |
| US10751342 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(4 years from now) | Active |
| US10653696 | Use of inhibitors of bruton's tyrosine kinase (BTK) |
Jun, 2031
(4 years from now) | Active |
| US8754090 | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Jun, 2031
(4 years from now) | Active |
| US10478439 | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Jun, 2031
(4 years from now) | Active |
| US9801883 | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Jun, 2031
(4 years from now) | Active |
| US9814721 | Use of inhibitors of bruton'S tyrosine kinase (BTK) |
Jun, 2031
(4 years from now) | Active |
| US8999999 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(4 years from now) | Active |
| US10004746 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(4 years from now) | Active |
| US10016435 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(4 years from now) | Active |
| US9125889 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(4 years from now) | Active |
| US11672803 | Use of inhibitors of Brutons tyrosine kinase (Btk) |
Jun, 2031
(4 years from now) | Active |
|
US8008309 (Pediatric) | Inhibitors of bruton's tyrosine kinase |
May, 2028
(1 year, 7 months from now) | Active |
|
US8563563 (Pediatric) | Inhibitors of bruton's tyrosine kinase |
Oct, 2027
(1 year, 24 days from now) | Active |
|
US8952015 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
|
US8754091 (Pediatric) | Inhibitors of bruton's tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
|
US8697711 (Pediatric) | Inhibitors of bruton'S tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
|
US8957079 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
|
US8497277 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
|
US8735403 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
|
US8703780 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
|
US9181257 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
|
US7514444 (Pediatric) | Inhibitors of bruton's tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
|
US8476284 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(8 months from now) | Active |
| US8563563 | Inhibitors of bruton's tyrosine kinase |
Apr, 2027
(6 months from now) | Active |
| US8497277 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
| US8952015 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
| US8476284 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
| US8703780 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
| US8754091 | Inhibitors of bruton's tyrosine kinase |
Dec, 2026
(2 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Imbruvica's patents.
Latest Legal Activities on Imbruvica's Patents
Given below is the list of recent legal activities going on the following patents of Imbruvica.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Dec, 2025 | US10010507 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Dec, 2025 | US10016435 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Nov, 2025 | US8754091 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Nov, 2025 | US10004746 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Nov, 2025 | US8754090 |
| Mail-Petition Decision - Dismissed | 22 Oct, 2025 | US11672803 (Litigated) |
| Email Notification | 22 Oct, 2025 | US11672803 (Litigated) |
| Petition Decision - Dismissed | 21 Oct, 2025 | US11672803 (Litigated) |
| Review Certificate Mailed | 21 Oct, 2025 | US11672803 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Oct, 2025 | US8735403 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Imbruvica and ongoing
litigations to
help you estimate the early arrival of Imbruvica generic.
Imbruvica's Litigations
Imbruvica been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 20, 2015, against patent number US8754090. The petitioner Coalition for Affordable Drugs IV LLC, challenged the validity of this patent, with Pharmacyclics, Inc. as the respondent. Click below to track the latest information on how companies are challenging Imbruvica's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11672803 | November, 2023 |
Final Written Decision
(29 Apr, 2025) | Pharmacyclics LLC | BeiGene USA, Inc. et al. |
| US9795604 | March, 2019 |
Final Written Decision
(24 Sep, 2020) | Pharmacyclics LLC et al. | Sandoz Inc. et al. |
| US8754090 | April, 2015 |
Institution Denied
(19 Oct, 2015) | Pharmacyclics, Inc. | Coalition for Affordable Drugs IV LLC |
FDA has granted some exclusivities to Imbruvica. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Imbruvica,
regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying
the generic
launch. Given below are details of the exclusivities granted to
Imbruvica.
Exclusivity Information
Imbruvica holds 27 exclusivities out of which 26 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Imbruvica's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-680) | Feb 12, 2017 |
| New Indication(I-689) | Jul 28, 2017 |
| New Indication(I-702) | Jan 29, 2018 |
| New Chemical Entity Exclusivity(NCE) | Nov 13, 2018 |
| New Indication(I-729) | Mar 04, 2019 |
| New Dosing Schedule(D-165) | May 06, 2019 |
| New Indication(I-736) | May 06, 2019 |
| New Indication(I-737) | May 06, 2019 |
| New Indication(I-741) | Jan 18, 2020 |
| New Indication(I-753) | Aug 02, 2020 |
| Orphan Drug Exclusivity(ODE-55) | Nov 13, 2020 |
| Orphan Drug Exclusivity(ODE-60) | Feb 12, 2021 |
| Orphan Drug Exclusivity(ODE-72) | Jul 28, 2021 |
| New Dosing Schedule(D-176) | Aug 24, 2021 |
| M(M-236) | Jan 25, 2022 |
| Orphan Drug Exclusivity(ODE-86) | Jan 29, 2022 |
| Orphan Drug Exclusivity(ODE-109) | Mar 04, 2023 |
| Orphan Drug Exclusivity(ODE-117) | May 06, 2023 |
| Orphan Drug Exclusivity(ODE-128) | Jan 18, 2024 |
| Orphan Drug Exclusivity(ODE) | Aug 02, 2024 |
| ODE*(ODE*) | Aug 02, 2024 |
| Orphan Drug Exclusivity(ODE-152) | Aug 02, 2024 |
| M(M-14) | Aug 24, 2025 |
| New Product(NP) | Aug 24, 2025 |
| New Patient Population(NPP) | Aug 24, 2025 |
| Pediatric Exclusivity(PED) | Feb 24, 2026 |
| Orphan Drug Exclusivity(ODE-405) | Aug 24, 2029 |
Several oppositions have been filed on Imbruvica's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Imbruvica's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Imbruvica patents.
Imbruvica's Oppositions Filed in EPO
Imbruvica has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 17, 2018, by Generics (U.K.) Limited. This opposition was filed on patent number EP12166302A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP12166302A | Oct, 2018 | Generics (U.K.) Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Imbruvica is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Imbruvica's family patents as well as insights into
ongoing legal events
on those patents.
Imbruvica's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Imbruvica:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Imbruvica's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 14, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Imbruvica Generic API suppliers:
Ibrutinib is the generic name for the brand Imbruvica. 2 different companies have already filed for the generic of Imbruvica, with Zydus Lifesciences having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Imbruvica's generic
How can I launch a generic of Imbruvica before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Imbruvica's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Imbruvica's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Imbruvica -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 14 Dec, 2018 | 30 Oct, 2033 | Eligible | 31 Mar, 2021 | Less | |
| 14 Dec, 2018 | 03 Mar, 2036 | Less | |||
| 05 Nov, 2018 | 03 Mar, 2036 | Less | |||
| 05 Nov, 2018 | 03 Mar, 2036 | Extinguished | Less | ||
| 13 Nov, 2017 | 24 Oct, 2034 | Deferred | 31 Mar, 2021 | High |
Alternative Brands for Imbruvica
Imbruvica which is used for treating various types of leukemias, lymphomas, and graft-versus-host disease, including those with specific genetic deletions., has several other brand drugs using the same active ingredient (Ibrutinib). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Novartis |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ibrutinib, Imbruvica's active ingredient. Check the complete list of approved generic manufacturers for Imbruvica
About Imbruvica
Imbruvica is a drug owned by Pharmacyclics Llc. It is used for treating various types of leukemias, lymphomas, and graft-versus-host disease, including those with specific genetic deletions. Imbruvica uses Ibrutinib as an active ingredient. Imbruvica was launched by Pharmacyclics in 2022.
Approval Date:
Imbruvica was approved by FDA for market use on 24 August, 2022.
Active Ingredient:
Imbruvica uses Ibrutinib as the active ingredient. Check out other Drugs and Companies using Ibrutinib ingredient
Treatment:
Imbruvica is used for treating various types of leukemias, lymphomas, and graft-versus-host disease, including those with specific genetic deletions.
Dosage:
Imbruvica is available in the following dosage forms - capsule form for oral use, suspension form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 70MG/ML | SUSPENSION | Prescription | ORAL |
| 420MG | TABLET | Prescription | ORAL |
| 560MG | TABLET | Discontinued | ORAL |
| 280MG | TABLET | Prescription | ORAL |
| 140MG | CAPSULE | Prescription | ORAL |
| 70MG | CAPSULE | Prescription | ORAL |