PharmaRadar360

PharmaRadar360

OncologyDrug intelligence

Imbruvica

Ibrutinib

Covalent Bruton's tyrosine kinase (BTK) inhibitor. Developed by AbbVie. Clinical, regulatory, and source evidence are connected below.

Company
AbbVie
Target / MOA
BTK
Aliases
Imbruvica 路 PCI-32765
Signals
24
Clinical trials
17
Approvals
3
Evidence sources
24

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Imbruvica 路 NDA205552, NDA210563, NDA217003 路 label version 65, effective Oct 21, 2025 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1. 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion. 1. 3 Waldenstr枚m鈥檚 Macroglobulinemia IMBRUVICA is indicated for the treatment of adult patients with Waldenstr枚m鈥檚 macroglobulinemia (WM). 1. 4 Chronic Graft versus Host Disease IMBRUVICA is indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

European Union (EMA)

Imbruvica 路 EMEA/H/C/003791 路 Authorised, authorised Oct 21, 2014 (Commission decision C(2014) 7873) 路 EPAR

Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory 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 Waldenstr枚m鈥檚 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.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

NDA205552 路 PHARMACYCLICS LLC 路 first approved Nov 13, 2013

16 efficacy supplements approved

NDA210563 路 PHARMACYCLICS LLC 路 first approved Feb 16, 2018

8 efficacy supplements approved

NDA217003 路 PHARMACYCLICS LLC 路 first approved Aug 24, 2022

European Union

  • Imbruvica: Authorised since Oct 21, 2014

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

NDA205552 (Orange Book)

67 listed patents, latest expiry Apr 24, 2035
  • US 7514444 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8476284 路 expires Dec 28, 2026 路 U-1650, U-1946
  • US 8497277 路 expires Dec 28, 2026 路 U-1491, U-1946, U-1650, U-2242, U-2241, U-3422
  • US 8697711 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8703780 路 expires Dec 28, 2026 路 U-1491
  • US 8735403 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8754091 路 expires Dec 28, 2026 路 drug product
  • US 8952015 路 expires Dec 28, 2026 路 U-1650, U-1491, U-1946
  • US 8957079 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 9181257 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8563563 路 expires Apr 26, 2027 路 U-1946, U-2219, U-1650, U-1491
  • US 7514444*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8476284*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8497277*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8697711*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8703780*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8735403*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8754091*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8952015*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8957079*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 9181257*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8563563*PED 路 expires Oct 26, 2027 路 no claim type flagged
  • US 8008309 路 expires Nov 13, 2027 路 drug substance, drug product
  • US 8008309*PED 路 expires May 13, 2028 路 no claim type flagged
  • US 10004746 路 expires Jun 3, 2031 路 U-2242, U-2241, U-1946, U-1684
  • US 10016435 路 expires Jun 3, 2031 路 U-1650
  • US 10478439 路 expires Jun 3, 2031 路 U-1684, U-1946, U-2665, U-1650, U-2241, U-2242, U-3422
  • US 10751342 路 expires Jun 3, 2031 路 U-2944, U-1946, U-1491, U-2943
  • US 11672803 路 expires Jun 3, 2031 路 U-1684, U-2242, U-2241, U-1946
  • US 8999999 路 expires Jun 3, 2031 路 U-1684, U-2228, U-1491, U-1683, U-1946
  • US 9125889 路 expires Jun 3, 2031 路 U-1745, U-1650
  • US 9801881 路 expires Jun 3, 2031 路 U-1491
  • US 9801883 路 expires Jun 3, 2031 路 U-2159
  • US 10004746*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 10016435*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 10478439*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 10751342*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 8999999*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 9125889*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 9801881*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 9801883*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 10106548 路 expires Jun 3, 2033 路 drug substance, drug product
  • US 10125140 路 expires Jun 3, 2033 路 drug substance, drug product
  • US 10294231 路 expires Jun 3, 2033 路 drug product
  • US 10294232 路 expires Jun 3, 2033 路 drug product
  • US 10752634 路 expires Jun 3, 2033 路 drug product 路 listed for some products only: IMBRUVICA 140MG
  • US 10961251 路 expires Jun 3, 2033 路 drug product
  • US 9713617 路 expires Jun 3, 2033 路 drug product
  • US 9725455 路 expires Jun 3, 2033 路 drug substance
  • US 9540382 路 expires Aug 18, 2033 路 U-1491, U-1946, U-1650, U-1684
  • US 9296753 路 expires Oct 30, 2033 路 drug substance, drug product
  • US 10106548*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 10125140*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 10294231*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 10294232*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 10752634*PED 路 expires Dec 3, 2033 路 no claim type flagged 路 listed for some products only: IMBRUVICA 140MG
  • US 10961251*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 9713617*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 9725455*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 9540382*PED 路 expires Feb 18, 2034 路 no claim type flagged
  • US 9296753*PED 路 expires Apr 30, 2034 路 no claim type flagged
  • US 10463668 路 expires Oct 24, 2034 路 U-2654
  • US 10695350 路 expires Oct 24, 2034 路 U-2846
  • US 9795604 路 expires Oct 24, 2034 路 U-2150, U-3422, U-2970, U-2969
  • US 10463668*PED 路 expires Apr 24, 2035 路 no claim type flagged
  • US 10695350*PED 路 expires Apr 24, 2035 路 no claim type flagged
  • US 9795604*PED 路 expires Apr 24, 2035 路 no claim type flagged

Exclusivity: ODE-405 until Aug 24, 2029; PED until Feb 24, 2030 路 Orange Book entry

NDA210563 (Orange Book)

74 listed patents, latest expiry Sep 3, 2036
  • US 7514444 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8476284 路 expires Dec 28, 2026 路 U-1946, U-2241, U-1650, U-1456, U-1947
  • US 8497277 路 expires Dec 28, 2026 路 U-2242, U-1650, U-1946, U-1491, U-2241, U-1947, U-1456, U-3422
  • US 8697711 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8703780 路 expires Dec 28, 2026 路 U-1491, U-2242
  • US 8735403 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8754091 路 expires Dec 28, 2026 路 drug product
  • US 8952015 路 expires Dec 28, 2026 路 U-1946, U-2242, U-2241, U-1491, U-1456, U-1947, U-1650
  • US 8957079 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 9181257 路 expires Dec 28, 2026 路 drug substance
  • US 8563563 路 expires Apr 26, 2027 路 U-1650, U-1946, U-1491, U-2242, U-2241
  • US 7514444*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8476284*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8497277*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8697711*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8703780*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8735403*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8754091*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8952015*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8957079*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 9181257*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8563563*PED 路 expires Oct 26, 2027 路 no claim type flagged
  • US 8008309 路 expires Nov 13, 2027 路 drug substance, drug product
  • US 8008309*PED 路 expires May 13, 2028 路 no claim type flagged
  • US 10004746 路 expires Jun 3, 2031 路 U-1946, U-1684, U-2241, U-2242
  • US 10016435 路 expires Jun 3, 2031 路 U-1650
  • US 10478439 路 expires Jun 3, 2031 路 U-2242, U-1650, U-1946, U-2665, U-2241, U-1947, U-1456, U-1684, U-3422
  • US 10653696 路 expires Jun 3, 2031 路 U-1456 路 listed for some products only: IMBRUVICA 560MG
  • US 10751342 路 expires Jun 3, 2031 路 U-1491, U-1946, U-2944, U-2943
  • US 11672803 路 expires Jun 3, 2031 路 U-1684, U-1946, U-2241, U-2242 路 listed for some products only: IMBRUVICA 140MG, IMBRUVICA 280MG, IMBRUVICA 420MG
  • US 8754090 路 expires Jun 3, 2031 路 U-1456 路 listed for some products only: IMBRUVICA 560MG
  • US 8999999 路 expires Jun 3, 2031 路 U-2242, U-2241, U-1946, U-1491
  • US 9125889 路 expires Jun 3, 2031 路 U-1650
  • US 9801881 路 expires Jun 3, 2031 路 U-1491, U-2242
  • US 9801883 路 expires Jun 3, 2031 路 U-2159, U-2243
  • US 9814721 路 expires Jun 3, 2031 路 U-1947 路 listed for some products only: IMBRUVICA 560MG
  • US 10004746*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 10016435*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 10478439*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 10653696*PED 路 expires Dec 3, 2031 路 no claim type flagged 路 listed for some products only: IMBRUVICA 560MG
  • US 10751342*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 8754090*PED 路 expires Dec 3, 2031 路 no claim type flagged 路 listed for some products only: IMBRUVICA 560MG
  • US 8999999*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 9125889*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 9801881*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 9801883*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 9814721*PED 路 expires Dec 3, 2031 路 no claim type flagged 路 listed for some products only: IMBRUVICA 560MG
  • US 10106548 路 expires Jun 3, 2033 路 drug substance, drug product
  • US 10125140 路 expires Jun 3, 2033 路 drug substance, drug product
  • US 10752634 路 expires Jun 3, 2033 路 drug product 路 listed for some products only: IMBRUVICA 140MG
  • US 10961251 路 expires Jun 3, 2033 路 drug product
  • US 9725455 路 expires Jun 3, 2033 路 drug substance
  • US 9296753 路 expires Oct 30, 2033 路 drug substance
  • US 10106548*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 10125140*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 10752634*PED 路 expires Dec 3, 2033 路 no claim type flagged 路 listed for some products only: IMBRUVICA 140MG
  • US 10961251*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 9725455*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 9296753*PED 路 expires Apr 30, 2034 路 no claim type flagged
  • US 10463668 路 expires Oct 24, 2034 路 U-2654
  • US 10695350 路 expires Oct 24, 2034 路 U-2846
  • US 9795604 路 expires Oct 24, 2034 路 U-3422, U-2970, U-2969
  • US 10463668*PED 路 expires Apr 24, 2035 路 no claim type flagged
  • US 10695350*PED 路 expires Apr 24, 2035 路 no claim type flagged
  • US 9795604*PED 路 expires Apr 24, 2035 路 no claim type flagged
  • US 10010507 路 expires Mar 3, 2036 路 drug product
  • US 10213386 路 expires Mar 3, 2036 路 drug product
  • US 10828259 路 expires Mar 3, 2036 路 drug product
  • US 12551448 路 expires Mar 3, 2036 路 drug product 路 listed for some products only: IMBRUVICA 140MG, IMBRUVICA 280MG, IMBRUVICA 420MG
  • US 9655857 路 expires Mar 3, 2036 路 drug product
  • US 10010507*PED 路 expires Sep 3, 2036 路 no claim type flagged
  • US 10213386*PED 路 expires Sep 3, 2036 路 no claim type flagged
  • US 10828259*PED 路 expires Sep 3, 2036 路 no claim type flagged
  • US 9655857*PED 路 expires Sep 3, 2036 路 no claim type flagged

Exclusivity: ODE-405 until Aug 24, 2029; PED until Feb 24, 2030 路 Orange Book entry

NDA217003 (Orange Book)

46 listed patents, latest expiry Jun 14, 2039
  • US 7514444 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8476284 路 expires Dec 28, 2026 路 U-3843, U-3844, U-3845
  • US 8497277 路 expires Dec 28, 2026 路 U-3422, U-3842, U-3843, U-3845, U-3844, U-2666, U-2970
  • US 8697711 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8703780 路 expires Dec 28, 2026 路 U-2666, U-3842
  • US 8735403 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 8754091 路 expires Dec 28, 2026 路 drug product
  • US 8952015 路 expires Dec 28, 2026 路 U-2666, U-3842, U-3843, U-3844, U-3845
  • US 8957079 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 9181257 路 expires Dec 28, 2026 路 drug substance
  • US 8563563 路 expires Apr 26, 2027 路 U-3844, U-3843, U-3842, U-2666, U-3845
  • US 7514444*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8497277*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8697711*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8735403*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8754091*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8957079*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 9181257*PED 路 expires Jun 28, 2027 路 no claim type flagged
  • US 8008309 路 expires Nov 13, 2027 路 drug substance, drug product
  • US 8008309*PED 路 expires May 13, 2028 路 no claim type flagged
  • US 10004746 路 expires Jun 3, 2031 路 U-3846, U-3848, U-3849, U-3847
  • US 10016435 路 expires Jun 3, 2031 路 U-3845
  • US 10478439 路 expires Jun 3, 2031 路 U-3422, U-3842, U-3844, U-2666, U-2970, U-3843, U-3845
  • US 10751342 路 expires Jun 3, 2031 路 U-2666, U-3844, U-3843, U-3842
  • US 11672803 路 expires Jun 3, 2031 路 U-2666, U-3842, U-3844, U-3843
  • US 8999999 路 expires Jun 3, 2031 路 U-2666, U-3842, U-3843, U-3844
  • US 9125889 路 expires Jun 3, 2031 路 U-3845
  • US 9801881 路 expires Jun 3, 2031 路 U-3846, U-3847
  • US 9801883 路 expires Jun 3, 2031 路 U-2666, U-3842, U-3843, U-3844
  • US 10478439*PED 路 expires Dec 3, 2031 路 no claim type flagged
  • US 10106548 路 expires Jun 3, 2033 路 drug substance, drug product
  • US 10125140 路 expires Jun 3, 2033 路 drug substance, drug product
  • US 10961251 路 expires Jun 3, 2033 路 drug product
  • US 9725455 路 expires Jun 3, 2033 路 drug substance
  • US 9296753 路 expires Oct 30, 2033 路 drug substance
  • US 10106548*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 10125140*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 10961251*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 9725455*PED 路 expires Dec 3, 2033 路 no claim type flagged
  • US 9296753*PED 路 expires Apr 30, 2034 路 no claim type flagged
  • US 10463668 路 expires Oct 24, 2034 路 U-2970
  • US 10695350 路 expires Oct 24, 2034 路 U-2970
  • US 9795604 路 expires Oct 24, 2034 路 U-3422, U-2970
  • US 9795604*PED 路 expires Apr 24, 2035 路 no claim type flagged
  • US 12364698 路 expires Apr 6, 2036 路 drug product
  • US 12201690 路 expires Jun 14, 2039 路 drug product

Exclusivity: ODE-405 until Aug 24, 2029; PED until Feb 24, 2030 路 Orange Book entry

Generics and biosimilars

2 approved generics (ANDA)
  • ZYDUS LIFESCIENCES GLOBAL FZE 路 ANDA211344 路 approved Mar 31, 2021
  • HETERO LABS LTD UNIT V 路 ANDA211182 路 approved Sep 8, 2026

*PED is FDA's mark for a patent's period extended by six months of pediatric exclusivity.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 17 linked records.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.