Imbruvica is a drug owned by Pharmacyclics Llc. It is protected by 81 US drug patents filed from 2017 to 2024 out of which none have expired yet. Imbruvica's patents will be open to challenges from 24 February, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 03, 2036. 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
(8 years from now) | Active |
| US9725455 | Crystalline forms of a bruton's tyrosine kinase inhibitor |
Jun, 2033
(8 years from now) | Active |
| US10106548 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(8 years from now) | Active |
| US10125140 | Crystalline forms of a bruton's tyrosine kinase inhibitor |
Jun, 2033
(8 years from now) | Active |
| US8008309 | Inhibitors of bruton's tyrosine kinase |
Nov, 2027
(2 years from now) | Active |
| US8735403 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 years from now) | Active |
| US9181257 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 years from now) | Active |
| US8957079 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 years from now) | Active |
| US7514444 | Inhibitors of bruton's tyrosine kinase |
Dec, 2026
(2 years from now) | Active |
| US8697711 | Inhibitors of bruton'S tyrosine kinase |
Dec, 2026
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10828259 (Pediatric) | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Sep, 2036
(11 years from now) | Active |
|
US10010507 (Pediatric) | Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor |
Sep, 2036
(11 years from now) | Active |
|
US10213386 (Pediatric) | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Sep, 2036
(11 years from now) | Active |
|
US9655857 (Pediatric) | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Sep, 2036
(11 years from now) | Active |
| US9655857 | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Mar, 2036
(11 years from now) | Active |
| US10213386 | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Mar, 2036
(11 years from now) | Active |
| US10010507 | Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor |
Mar, 2036
(11 years from now) | Active |
| US10828259 | Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor |
Mar, 2036
(11 years from now) | Active |
|
US9795604 (Pediatric) | Methods of treating and preventing graft versus host disease |
Apr, 2035
(10 years from now) | Active |
|
US10695350 (Pediatric) | Methods of treating and preventing graft versus host disease |
Apr, 2035
(10 years from now) | Active |
|
US10463668 (Pediatric) | Methods of treating and preventing graft versus host disease |
Apr, 2035
(10 years from now) | Active |
| US10463668 | Methods of treating and preventing graft versus host disease |
Oct, 2034
(9 years from now) | Active |
| US9795604 | Methods of treating and preventing graft versus host disease |
Oct, 2034
(9 years from now) | Active |
| US10695350 | Methods of treating and preventing graft versus host disease |
Oct, 2034
(9 years from now) | Active |
|
US9296753 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Apr, 2034
(9 years from now) | Active |
|
US9540382 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Feb, 2034
(9 years from now) | Active |
|
US10106548 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(9 years from now) | Active |
|
US10125140 (Pediatric) | Crystalline forms of a bruton's tyrosine kinase inhibitor |
Dec, 2033
(9 years from now) | Active |
|
US10961251 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(9 years from now) | Active |
|
US9725455 (Pediatric) | Crystalline forms of a bruton's tyrosine kinase inhibitor |
Dec, 2033
(9 years from now) | Active |
|
US10752634 (Pediatric) | Crystalline forms of a brutons tyrosine kinase inhibitor |
Dec, 2033
(9 years from now) | Active |
|
US10294232 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(9 years from now) | Active |
|
US10294231 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(9 years from now) | Active |
|
US9713617 (Pediatric) | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Dec, 2033
(9 years from now) | Active |
| US9540382 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Aug, 2033
(8 years from now) | Active |
| US10752634 | Crystalline forms of a brutons tyrosine kinase inhibitor |
Jun, 2033
(8 years from now) | Active |
| US9713617 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(8 years from now) | Active |
| US10961251 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(8 years from now) | Active |
| US10294231 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(8 years from now) | Active |
| US10294232 | Crystalline forms of a Bruton's tyrosine kinase inhibitor |
Jun, 2033
(8 years from now) | Active |
|
US10478439 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Dec, 2031
(7 years from now) | Active |
|
US9814721 (Pediatric) | Use of inhibitors of bruton'S tyrosine kinase (BTK) |
Dec, 2031
(7 years from now) | Active |
|
US10653696 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (BTK) |
Dec, 2031
(7 years from now) | Active |
|
US8754090 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Dec, 2031
(7 years from now) | Active |
|
US9125889 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(7 years from now) | Active |
|
US10004746 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(7 years from now) | Active |
|
US9801883 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Dec, 2031
(7 years from now) | Active |
|
US9801881 (Pediatric) | Use of inhibitors of bruton's tyrosine kinase (BTK) |
Dec, 2031
(7 years from now) | Active |
|
US8999999 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(7 years from now) | Active |
|
US10016435 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(7 years from now) | Active |
|
US10751342 (Pediatric) | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Dec, 2031
(7 years from now) | Active |
| US9801881 | Use of inhibitors of bruton's tyrosine kinase (BTK) |
Jun, 2031
(6 years from now) | Active |
| US10016435 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(6 years from now) | Active |
| US8999999 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(6 years from now) | Active |
| US10004746 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(6 years from now) | Active |
| US9814721 | Use of inhibitors of bruton'S tyrosine kinase (BTK) |
Jun, 2031
(6 years from now) | Active |
| US10653696 | Use of inhibitors of bruton's tyrosine kinase (BTK) |
Jun, 2031
(6 years from now) | Active |
| US10478439 | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Jun, 2031
(6 years from now) | Active |
| US11672803 | Use of inhibitors of Brutons tyrosine kinase (Btk) |
Jun, 2031
(6 years from now) | Active |
| US8754090 | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Jun, 2031
(6 years from now) | Active |
| US9125889 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(6 years from now) | Active |
| US9801883 | Use of inhibitors of bruton's tyrosine kinase (Btk) |
Jun, 2031
(6 years from now) | Active |
| US10751342 | Use of inhibitors of Bruton's tyrosine kinase (Btk) |
Jun, 2031
(6 years from now) | Active |
|
US8008309 (Pediatric) | Inhibitors of bruton's tyrosine kinase |
May, 2028
(3 years from now) | Active |
|
US8563563 (Pediatric) | Inhibitors of bruton's tyrosine kinase |
Oct, 2027
(2 years from now) | Active |
|
US8735403 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
|
US7514444 (Pediatric) | Inhibitors of bruton's tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
|
US8703780 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
|
US8957079 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
|
US9181257 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
|
US8754091 (Pediatric) | Inhibitors of bruton's tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
|
US8952015 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
|
US8497277 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
|
US8476284 (Pediatric) | Inhibitors of Bruton's tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
|
US8697711 (Pediatric) | Inhibitors of bruton'S tyrosine kinase |
Jun, 2027
(2 years from now) | Active |
| US8563563 | Inhibitors of bruton's tyrosine kinase |
Apr, 2027
(2 years from now) | Active |
| US8703780 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 years from now) | Active |
| US8952015 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 years from now) | Active |
| US8497277 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 years from now) | Active |
| US8476284 | Inhibitors of Bruton's tyrosine kinase |
Dec, 2026
(2 years from now) | Active |
| US8754091 | Inhibitors of bruton's tyrosine kinase |
Dec, 2026
(2 years 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 | 13 Jun, 2024 | US9540382 |
| Request for Trial Granted Critical | 01 May, 2024 | US11672803 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Apr, 2024 | US10828259 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Jan, 2024 | US10752634 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Jan, 2024 | US10751342 (Litigated) |
| Letter from FDA or Dept of Agriculture re PTE application | 18 Dec, 2023 | US8008309 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Nov, 2023 | US10695350 |
| Petition Requesting Trial | 06 Nov, 2023 | US11672803 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Oct, 2023 | US10653696 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Aug, 2023 | US9296753 |
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 |
Trial Instituted
(01 May, 2024) | 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 |
Terminated-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 22 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
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 Sep 03, 2036 (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. 1 company has already filed for the generic of Imbruvica. 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 | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 70 mg | 14 Dec, 2018 | 1 | 31 Mar, 2021 | 30 Oct, 2033 | Eligible |
| 140 mg | 13 Nov, 2017 | 8 | 31 Mar, 2021 | 24 Oct, 2034 | Deferred |
| 140 mg and 560 mg | 05 Nov, 2018 | 1 | 03 Mar, 2036 | ||
| 280 mg and 420 mg | 14 Dec, 2018 | 1 | 03 Mar, 2036 |
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 Llc in 2018.
Approval Date:
Imbruvica was approved by FDA for market use on 16 February, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Imbruvica is 16 February, 2018, its NCE-1 date is estimated to be 24 February, 2025.
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 - tablet form for oral use, capsule form for oral use, suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 280MG | TABLET | Prescription | ORAL |
| 420MG | TABLET | Prescription | ORAL |
| 560MG | TABLET | Discontinued | ORAL |
| 140MG | TABLET | Prescription | ORAL |
| 70MG/ML | SUSPENSION | Prescription | ORAL |
| 70MG | CAPSULE | Prescription | ORAL |