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Imbruvica

Ibrutinib · Tablet, Film Coated

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Imbruvica
Generic name
Ibrutinib
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Pharmacyclics LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ibrutinib 140 mg/1 1442986 View
Ibrutinib 280 mg/1 1442986 View
Ibrutinib 420 mg/1 1442986 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Kinase Inhibitor [EPC] EPC All 89 members
Protein Kinase Inhibitors [MoA] MoA All 41 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
210563
Application type
NDA · New Drug Application
Approval date
February 16, 2018
Sponsor
PHARMACYCLICS LLC
Products on application
4
Submissions recorded
18
Products approved under application 210563.
Product Trade name Form Strength Ingredient Status TE Flags
210563-001 IMBRUVICA TABLET IBRUTINIB Prescription — RLD
210563-002 IMBRUVICA TABLET IBRUTINIB Prescription — RLD
210563-003 IMBRUVICA TABLET IBRUTINIB Prescription — RLD RS
210563-004 IMBRUVICA TABLET IBRUTINIB Discontinued — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8476284 December 28, 2026 001 No U-1946 March 6, 2018
8497277 December 28, 2026 001 No U-2242 March 6, 2018
8497277 December 28, 2026 001 No U-1650 March 6, 2018
8703780 December 28, 2026 001 No U-1491 March 6, 2018
8952015 December 28, 2026 001 No U-1491 March 6, 2018
8952015 December 28, 2026 001 No U-2241 March 6, 2018
8952015 December 28, 2026 001 No U-2242 March 6, 2018
8952015 December 28, 2026 001 No U-1650 March 6, 2018
8497277 December 28, 2026 001 No U-2241 March 6, 2018
8497277 December 28, 2026 001 No U-1946 March 6, 2018
8476284 December 28, 2026 001 No U-1650 March 6, 2018
8703780 December 28, 2026 001 No U-2242 March 6, 2018
8952015 December 28, 2026 001 No U-1946 March 6, 2018
8497277 December 28, 2026 001 No U-3422 March 6, 2018
8476284 December 28, 2026 001 No U-2241 March 6, 2018
8497277 December 28, 2026 001 No U-1491 March 6, 2018
8754091 December 28, 2026 001 No March 6, 2018
7514444 December 28, 2026 001 Yes March 6, 2018
8697711 December 28, 2026 001 Yes March 6, 2018
8957079 December 28, 2026 001 Yes March 6, 2018
9181257 December 28, 2026 001 Yes March 6, 2018
8735403 December 28, 2026 001 Yes March 6, 2018
8497277 December 28, 2026 002 No U-1946 March 6, 2018
8497277 December 28, 2026 002 No U-2242 March 6, 2018
8497277 December 28, 2026 002 No U-1491 March 6, 2018
8703780 December 28, 2026 002 No U-2242 March 6, 2018
8952015 December 28, 2026 002 No U-1946 March 6, 2018
8952015 December 28, 2026 002 No U-2242 March 6, 2018
8952015 December 28, 2026 002 No U-2241 March 6, 2018
8476284 December 28, 2026 002 No U-2241 March 6, 2018
8476284 December 28, 2026 002 No U-1650 March 6, 2018
8476284 December 28, 2026 002 No U-1946 March 6, 2018
8497277 December 28, 2026 002 No U-2241 March 6, 2018
8703780 December 28, 2026 002 No U-1491 March 6, 2018
8497277 December 28, 2026 002 No U-1650 March 6, 2018
8952015 December 28, 2026 002 No U-1650 March 6, 2018
8952015 December 28, 2026 002 No U-1491 March 6, 2018
8497277 December 28, 2026 002 No U-3422 March 6, 2018
8754091 December 28, 2026 002 No March 6, 2018
8957079 December 28, 2026 002 Yes March 6, 2018
7514444 December 28, 2026 002 Yes March 6, 2018
8735403 December 28, 2026 002 Yes March 6, 2018
9181257 December 28, 2026 002 Yes March 6, 2018
8697711 December 28, 2026 002 Yes March 6, 2018
8497277 December 28, 2026 003 No U-2241 March 6, 2018
8497277 December 28, 2026 003 No U-1650 March 6, 2018
8952015 December 28, 2026 003 No U-2241 March 6, 2018
8476284 December 28, 2026 003 No U-2241 March 6, 2018
8497277 December 28, 2026 003 No U-1491 March 6, 2018
8952015 December 28, 2026 003 No U-2242 March 6, 2018
8952015 December 28, 2026 003 No U-1491 March 6, 2018
8952015 December 28, 2026 003 No U-1650 March 6, 2018
8703780 December 28, 2026 003 No U-1491 March 6, 2018
8703780 December 28, 2026 003 No U-2242 March 6, 2018
8952015 December 28, 2026 003 No U-1946 March 6, 2018
8497277 December 28, 2026 003 No U-3422 March 6, 2018
8476284 December 28, 2026 003 No U-1946 March 6, 2018
8476284 December 28, 2026 003 No U-1650 March 6, 2018
8497277 December 28, 2026 003 No U-1946 March 6, 2018
8497277 December 28, 2026 003 No U-2242 March 6, 2018
9181257 December 28, 2026 003 Yes March 6, 2018
8957079 December 28, 2026 003 Yes March 6, 2018
7514444 December 28, 2026 003 Yes March 6, 2018
8754091 December 28, 2026 003 No March 6, 2018
8735403 December 28, 2026 003 Yes March 6, 2018
8697711 December 28, 2026 003 Yes March 6, 2018
8952015 December 28, 2026 004 No U-1456 March 6, 2018
8952015 December 28, 2026 004 No U-1947 March 6, 2018
8703780 December 28, 2026 004 No U-1491 March 6, 2018
8497277 December 28, 2026 004 No U-2242 March 6, 2018
8497277 December 28, 2026 004 No U-1491 March 6, 2018
8476284 December 28, 2026 004 No U-1650 March 6, 2018
8476284 December 28, 2026 004 No U-1456 March 6, 2018
8952015 December 28, 2026 004 No U-1491 March 6, 2018
8952015 December 28, 2026 004 No U-2242 March 6, 2018
8952015 December 28, 2026 004 No U-1946 March 6, 2018
8703780 December 28, 2026 004 No U-2242 March 6, 2018
8497277 December 28, 2026 004 No U-2241 March 6, 2018
8497277 December 28, 2026 004 No U-1947 March 6, 2018
8497277 December 28, 2026 004 No U-1650 March 6, 2018
8476284 December 28, 2026 004 No U-1947 March 6, 2018
8476284 December 28, 2026 004 No U-1946 March 6, 2018
8497277 December 28, 2026 004 No U-1946 March 6, 2018
8497277 December 28, 2026 004 No U-1456 March 6, 2018
8952015 December 28, 2026 004 No U-1650 March 6, 2018
8476284 December 28, 2026 004 No U-2241 March 6, 2018
8952015 December 28, 2026 004 No U-2241 March 6, 2018
8754091 December 28, 2026 004 No March 6, 2018
9181257 December 28, 2026 004 Yes March 6, 2018
7514444 December 28, 2026 004 Yes March 6, 2018
8735403 December 28, 2026 004 Yes March 6, 2018
8957079 December 28, 2026 004 Yes March 6, 2018
8697711 December 28, 2026 004 Yes March 6, 2018
8563563 April 26, 2027 001 No U-1650 March 6, 2018
8563563 April 26, 2027 001 No U-1946 March 6, 2018
8563563 April 26, 2027 001 No U-2242 March 6, 2018
8563563 April 26, 2027 001 No U-2241 March 6, 2018
8563563 April 26, 2027 001 No U-1491 March 6, 2018
8563563 April 26, 2027 002 No U-1491 March 6, 2018
8563563 April 26, 2027 002 No U-2242 March 6, 2018
8563563 April 26, 2027 002 No U-1650 March 6, 2018
8563563 April 26, 2027 002 No U-1946 March 6, 2018
8563563 April 26, 2027 002 No U-2241 March 6, 2018
8563563 April 26, 2027 003 No U-2242 March 6, 2018
8563563 April 26, 2027 003 No U-1650 March 6, 2018
8563563 April 26, 2027 003 No U-2241 March 6, 2018
8563563 April 26, 2027 003 No U-1946 March 6, 2018
8563563 April 26, 2027 003 No U-1491 March 6, 2018
8563563 April 26, 2027 004 No U-1491 March 6, 2018
8563563 April 26, 2027 004 No U-2241 March 6, 2018
8563563 April 26, 2027 004 No U-1946 March 6, 2018
8563563 April 26, 2027 004 No U-1650 March 6, 2018
8563563 April 26, 2027 004 No U-2242 March 6, 2018
8703780*PED June 28, 2027 001 No —
8754091*PED June 28, 2027 001 No —
8735403*PED June 28, 2027 001 No —
8697711*PED June 28, 2027 001 No —
8957079*PED June 28, 2027 001 No —
8952015*PED June 28, 2027 001 No —
8497277*PED June 28, 2027 001 No —
9181257*PED June 28, 2027 001 No —
8476284*PED June 28, 2027 001 No —
7514444*PED June 28, 2027 001 No —
8703780*PED June 28, 2027 002 No —
8497277*PED June 28, 2027 002 No —
8952015*PED June 28, 2027 002 No —
8754091*PED June 28, 2027 002 No —
8697711*PED June 28, 2027 002 No —
8957079*PED June 28, 2027 002 No —
8735403*PED June 28, 2027 002 No —
9181257*PED June 28, 2027 002 No —
8476284*PED June 28, 2027 002 No —
7514444*PED June 28, 2027 002 No —
8497277*PED June 28, 2027 003 No —
8957079*PED June 28, 2027 003 No —
8703780*PED June 28, 2027 003 No —
8735403*PED June 28, 2027 003 No —
8952015*PED June 28, 2027 003 No —
8754091*PED June 28, 2027 003 No —
8697711*PED June 28, 2027 003 No —
9181257*PED June 28, 2027 003 No —
8476284*PED June 28, 2027 003 No —
7514444*PED June 28, 2027 003 No —
8957079*PED June 28, 2027 004 No —
8754091*PED June 28, 2027 004 No —
8497277*PED June 28, 2027 004 No —
8697711*PED June 28, 2027 004 No —
8952015*PED June 28, 2027 004 No —
8735403*PED June 28, 2027 004 No —
8703780*PED June 28, 2027 004 No —
8476284*PED June 28, 2027 004 No —
9181257*PED June 28, 2027 004 No —
7514444*PED June 28, 2027 004 No —
8563563*PED October 26, 2027 001 No —
8563563*PED October 26, 2027 002 No —
8563563*PED October 26, 2027 003 No —
8563563*PED October 26, 2027 004 No —
8008309 November 13, 2027 001 Yes March 6, 2018
8008309 November 13, 2027 002 Yes March 6, 2018
8008309 November 13, 2027 003 Yes March 6, 2018
8008309 November 13, 2027 004 Yes March 6, 2018
8008309*PED May 13, 2028 001 No —
8008309*PED May 13, 2028 002 No —
8008309*PED May 13, 2028 003 No —
8008309*PED May 13, 2028 004 No —
9801883 June 3, 2031 001 No U-2159 March 6, 2018
9801883 June 3, 2031 001 No U-2243 March 6, 2018
9125889 June 3, 2031 001 No U-1650 March 6, 2018
9801881 June 3, 2031 001 No U-1491 March 6, 2018
10004746 June 3, 2031 001 No U-1946 July 17, 2018
8999999 June 3, 2031 001 No U-2241 March 6, 2018
8999999 June 3, 2031 001 No U-1491 March 6, 2018
10004746 June 3, 2031 001 No U-2242 July 17, 2018
10004746 June 3, 2031 001 No U-1684 July 17, 2018
10016435 June 3, 2031 001 No U-1650 August 2, 2018
10478439 June 3, 2031 001 No U-2242 December 10, 2019
10478439 June 3, 2031 001 No U-1650 December 10, 2019
10478439 June 3, 2031 001 No U-1946 December 10, 2019
10478439 June 3, 2031 001 No U-2665 December 10, 2019
10478439 June 3, 2031 001 No U-2241 December 10, 2019
10478439 June 3, 2031 001 No U-1684 December 10, 2019
8999999 June 3, 2031 001 No U-2242 March 6, 2018
9801881 June 3, 2031 001 No U-2242 March 6, 2018
10004746 June 3, 2031 001 No U-2241 July 17, 2018
8999999 June 3, 2031 001 No U-1946 March 6, 2018
10751342 June 3, 2031 001 No U-1491 September 10, 2020
10478439 June 3, 2031 001 No U-3422 December 10, 2019
10751342 June 3, 2031 001 No U-2944 September 10, 2020
10751342 June 3, 2031 001 No U-1946 September 10, 2020
10751342 June 3, 2031 001 No U-2943 September 10, 2020
11672803 June 3, 2031 001 No U-1684 July 14, 2023
11672803 June 3, 2031 001 No U-1946 July 14, 2023
11672803 June 3, 2031 001 No U-2241 July 14, 2023
11672803 June 3, 2031 001 No U-2242 July 14, 2023
9801883 June 3, 2031 002 No U-2243 March 6, 2018
9801883 June 3, 2031 002 No U-2159 March 6, 2018
9125889 June 3, 2031 002 No U-1650 March 6, 2018
8999999 June 3, 2031 002 No U-2242 March 6, 2018
8999999 June 3, 2031 002 No U-2241 March 6, 2018
8999999 June 3, 2031 002 No U-1946 March 6, 2018
9801881 June 3, 2031 002 No U-1491 March 6, 2018
10004746 June 3, 2031 002 No U-1684 July 17, 2018
10004746 June 3, 2031 002 No U-2241 July 17, 2018
10016435 June 3, 2031 002 No U-1650 August 2, 2018
10004746 June 3, 2031 002 No U-1946 July 17, 2018
10004746 June 3, 2031 002 No U-2242 July 17, 2018
10478439 June 3, 2031 002 No U-2665 December 10, 2019
10478439 June 3, 2031 002 No U-1946 December 10, 2019
10478439 June 3, 2031 002 No U-1650 December 10, 2019
10478439 June 3, 2031 002 No U-2242 December 10, 2019
10478439 June 3, 2031 002 No U-2241 December 10, 2019
10478439 June 3, 2031 002 No U-1684 December 10, 2019
8999999 June 3, 2031 002 No U-1491 March 6, 2018
9801881 June 3, 2031 002 No U-2242 March 6, 2018
10478439 June 3, 2031 002 No U-3422 December 10, 2019
10751342 June 3, 2031 002 No U-2944 September 10, 2020
10751342 June 3, 2031 002 No U-1946 September 10, 2020
10751342 June 3, 2031 002 No U-2943 September 10, 2020
10751342 June 3, 2031 002 No U-1491 September 10, 2020
11672803 June 3, 2031 002 No U-1684 July 14, 2023
11672803 June 3, 2031 002 No U-1946 July 14, 2023
11672803 June 3, 2031 002 No U-2241 July 14, 2023
11672803 June 3, 2031 002 No U-2242 July 14, 2023
8999999 June 3, 2031 003 No U-2242 March 6, 2018
8999999 June 3, 2031 003 No U-2241 March 6, 2018
8999999 June 3, 2031 003 No U-1491 March 6, 2018
9801881 June 3, 2031 003 No U-2242 March 6, 2018
9125889 June 3, 2031 003 No U-1650 March 6, 2018
9801883 June 3, 2031 003 No U-2159 March 6, 2018
9801881 June 3, 2031 003 No U-1491 March 6, 2018
10004746 June 3, 2031 003 No U-1684 July 17, 2018
10016435 June 3, 2031 003 No U-1650 August 2, 2018
10478439 June 3, 2031 003 No U-2241 December 10, 2019
10478439 June 3, 2031 003 No U-2665 December 10, 2019
10478439 June 3, 2031 003 No U-2242 December 10, 2019
10478439 June 3, 2031 003 No U-1946 December 10, 2019
10478439 June 3, 2031 003 No U-1650 December 10, 2019
10478439 June 3, 2031 003 No U-1684 December 10, 2019
8999999 June 3, 2031 003 No U-1946 March 6, 2018
9801883 June 3, 2031 003 No U-2243 March 6, 2018
10004746 June 3, 2031 003 No U-2242 July 17, 2018
10478439 June 3, 2031 003 No U-3422 December 10, 2019
10004746 June 3, 2031 003 No U-2241 July 17, 2018
10004746 June 3, 2031 003 No U-1946 July 17, 2018
10751342 June 3, 2031 003 No U-1946 September 10, 2020
10751342 June 3, 2031 003 No U-1491 September 10, 2020
10751342 June 3, 2031 003 No U-2944 September 10, 2020
10751342 June 3, 2031 003 No U-2943 September 10, 2020
11672803 June 3, 2031 003 No U-1684 July 14, 2023
11672803 June 3, 2031 003 No U-1946 July 14, 2023
11672803 June 3, 2031 003 No U-2241 July 14, 2023
11672803 June 3, 2031 003 No U-2242 July 14, 2023
9125889 June 3, 2031 004 No U-1650 March 6, 2018
9801881 June 3, 2031 004 No U-1491 March 6, 2018
8999999 June 3, 2031 004 No U-1946 March 6, 2018
8999999 June 3, 2031 004 No U-1491 March 6, 2018
10004746 June 3, 2031 004 No U-1946 July 17, 2018
10004746 June 3, 2031 004 No U-2241 July 17, 2018
10016435 June 3, 2031 004 No U-1650 August 2, 2018
8754090 June 3, 2031 004 No U-1456 March 6, 2018
9801881 June 3, 2031 004 No U-2242 March 6, 2018
8999999 June 3, 2031 004 No U-2241 March 6, 2018
9814721 June 3, 2031 004 No U-1947 March 6, 2018
10004746 June 3, 2031 004 No U-1684 July 17, 2018
10004746 June 3, 2031 004 No U-2242 July 17, 2018
10478439 June 3, 2031 004 No U-1650 December 10, 2019
10478439 June 3, 2031 004 No U-1947 December 10, 2019
10478439 June 3, 2031 004 No U-1456 December 10, 2019
10478439 June 3, 2031 004 No U-1946 December 10, 2019
10478439 June 3, 2031 004 No U-2241 December 10, 2019
10478439 June 3, 2031 004 No U-2665 December 10, 2019
10478439 June 3, 2031 004 No U-2242 December 10, 2019
10478439 June 3, 2031 004 No U-1684 December 10, 2019
8999999 June 3, 2031 004 No U-2242 March 6, 2018
9801883 June 3, 2031 004 No U-2243 March 6, 2018
10653696 June 3, 2031 004 No U-1456 June 12, 2020
10751342 June 3, 2031 004 No U-2943 September 10, 2020
10751342 June 3, 2031 004 No U-2944 September 10, 2020
10751342 June 3, 2031 004 No U-1946 September 10, 2020
10751342 June 3, 2031 004 No U-1491 September 10, 2020
9801883 June 3, 2031 004 No U-2159 March 6, 2018
10016435*PED December 3, 2031 001 No —
8999999*PED December 3, 2031 001 No —
9801881*PED December 3, 2031 001 No —
9125889*PED December 3, 2031 001 No —
9801883*PED December 3, 2031 001 No —
10004746*PED December 3, 2031 001 No —
10751342*PED December 3, 2031 001 No —
10478439*PED December 3, 2031 001 No —
10016435*PED December 3, 2031 002 No —
8999999*PED December 3, 2031 002 No —
9125889*PED December 3, 2031 002 No —
9801881*PED December 3, 2031 002 No —
9801883*PED December 3, 2031 002 No —
10004746*PED December 3, 2031 002 No —
10751342*PED December 3, 2031 002 No —
10478439*PED December 3, 2031 002 No —
10016435*PED December 3, 2031 003 No —
8999999*PED December 3, 2031 003 No —
9801883*PED December 3, 2031 003 No —
9125889*PED December 3, 2031 003 No —
9801881*PED December 3, 2031 003 No —
10004746*PED December 3, 2031 003 No —
10751342*PED December 3, 2031 003 No —
10478439*PED December 3, 2031 003 No —
10016435*PED December 3, 2031 004 No —
8999999*PED December 3, 2031 004 No —
8754090*PED December 3, 2031 004 No —
9814721*PED December 3, 2031 004 No —
9801881*PED December 3, 2031 004 No —
9125889*PED December 3, 2031 004 No —
9801883*PED December 3, 2031 004 No —
10004746*PED December 3, 2031 004 No —
10751342*PED December 3, 2031 004 No —
10478439*PED December 3, 2031 004 No —
10653696*PED December 3, 2031 004 No —
10752634 June 3, 2033 001 No September 10, 2020
10106548 June 3, 2033 001 Yes October 26, 2018
10961251 June 3, 2033 001 No April 16, 2021
9725455 June 3, 2033 001 Yes March 6, 2018
10125140 June 3, 2033 001 Yes November 16, 2018
10961251 June 3, 2033 002 No April 16, 2021
10106548 June 3, 2033 002 Yes October 26, 2018
9725455 June 3, 2033 002 Yes March 6, 2018
10125140 June 3, 2033 002 Yes November 16, 2018
9725455 June 3, 2033 003 Yes March 6, 2018
10125140 June 3, 2033 003 Yes November 16, 2018
10106548 June 3, 2033 003 Yes October 26, 2018
10961251 June 3, 2033 003 No April 16, 2021
10125140 June 3, 2033 004 Yes November 16, 2018
9725455 June 3, 2033 004 Yes March 6, 2018
10106548 June 3, 2033 004 Yes October 26, 2018
10961251 June 3, 2033 004 No April 16, 2021
9296753 October 30, 2033 001 Yes March 6, 2018
9296753 October 30, 2033 002 Yes March 6, 2018
9296753 October 30, 2033 003 Yes March 6, 2018
9296753 October 30, 2033 004 Yes March 6, 2018
9725455*PED December 3, 2033 001 No —
10106548*PED December 3, 2033 001 No —
10125140*PED December 3, 2033 001 No —
10752634*PED December 3, 2033 001 No —
10961251*PED December 3, 2033 001 No —
9725455*PED December 3, 2033 002 No —
10106548*PED December 3, 2033 002 No —
10125140*PED December 3, 2033 002 No —
10961251*PED December 3, 2033 002 No —
9725455*PED December 3, 2033 003 No —
10106548*PED December 3, 2033 003 No —
10125140*PED December 3, 2033 003 No —
10961251*PED December 3, 2033 003 No —
9725455*PED December 3, 2033 004 No —
10106548*PED December 3, 2033 004 No —
10125140*PED December 3, 2033 004 No —
10961251*PED December 3, 2033 004 No —
9296753*PED April 30, 2034 001 No —
9296753*PED April 30, 2034 002 No —
9296753*PED April 30, 2034 003 No —
9296753*PED April 30, 2034 004 No —
10463668 October 24, 2034 001 No U-2654 November 15, 2019
10695350 October 24, 2034 001 No U-2846 July 13, 2020
9795604 October 24, 2034 001 No U-3422 March 6, 2018
9795604 October 24, 2034 001 No U-2970 March 6, 2018
9795604 October 24, 2034 001 No U-2969 March 6, 2018
10463668 October 24, 2034 002 No U-2654 November 15, 2019
10695350 October 24, 2034 002 No U-2846 July 13, 2020
9795604 October 24, 2034 002 No U-3422 March 6, 2018
9795604 October 24, 2034 002 No U-2969 March 6, 2018
9795604 October 24, 2034 002 No U-2970 March 6, 2018
10463668 October 24, 2034 003 No U-2654 November 15, 2019
10695350 October 24, 2034 003 No U-2846 July 13, 2020
9795604 October 24, 2034 003 No U-3422 March 6, 2018
9795604 October 24, 2034 003 No U-2970 March 6, 2018
9795604 October 24, 2034 003 No U-2969 March 6, 2018
10463668 October 24, 2034 004 No U-2654 November 15, 2019
10695350 October 24, 2034 004 No U-2846 July 13, 2020
9795604 October 24, 2034 004 No U-2969 March 6, 2018
9795604 October 24, 2034 004 No U-2970 March 6, 2018
9795604*PED April 24, 2035 001 No —
10463668*PED April 24, 2035 001 No —
10695350*PED April 24, 2035 001 No —
9795604*PED April 24, 2035 002 No —
10463668*PED April 24, 2035 002 No —
10695350*PED April 24, 2035 002 No —
9795604*PED April 24, 2035 003 No —
10463668*PED April 24, 2035 003 No —
10695350*PED April 24, 2035 003 No —
9795604*PED April 24, 2035 004 No —
10463668*PED April 24, 2035 004 No —
10695350*PED April 24, 2035 004 No —
10213386 March 3, 2036 001 No March 8, 2019
9655857 March 3, 2036 001 No March 6, 2018
12551448 March 3, 2036 001 No March 17, 2026
10010507 March 3, 2036 001 No July 17, 2018
10828259 March 3, 2036 001 No November 18, 2020
12551448 March 3, 2036 002 No March 17, 2026
10010507 March 3, 2036 002 No July 17, 2018
10213386 March 3, 2036 002 No March 8, 2019
9655857 March 3, 2036 002 No March 6, 2018
10828259 March 3, 2036 002 No November 18, 2020
12551448 March 3, 2036 003 No March 17, 2026
10213386 March 3, 2036 003 No March 8, 2019
10010507 March 3, 2036 003 No July 17, 2018
9655857 March 3, 2036 003 No March 6, 2018
10828259 March 3, 2036 003 No November 18, 2020
10010507 March 3, 2036 004 No July 17, 2018
10213386 March 3, 2036 004 No March 8, 2019
10828259 March 3, 2036 004 No November 18, 2020
9655857 March 3, 2036 004 No March 6, 2018
9655857*PED September 3, 2036 001 No —
10010507*PED September 3, 2036 001 No —
10213386*PED September 3, 2036 001 No —
10828259*PED September 3, 2036 001 No —
9655857*PED September 3, 2036 002 No —
10010507*PED September 3, 2036 002 No —
10213386*PED September 3, 2036 002 No —
10828259*PED September 3, 2036 002 No —
9655857*PED September 3, 2036 003 No —
10010507*PED September 3, 2036 003 No —
10213386*PED September 3, 2036 003 No —
10828259*PED September 3, 2036 003 No —
9655857*PED September 3, 2036 004 No —
10010507*PED September 3, 2036 004 No —
10213386*PED September 3, 2036 004 No —
10828259*PED September 3, 2036 004 No —
Regulatory exclusivity periods.
Code Expires Product
NPP August 24, 2025 001
NPP August 24, 2025 002
NPP August 24, 2025 003
NPP August 24, 2025 004
PED February 24, 2026 001
PED February 24, 2026 002
PED February 24, 2026 003
PED February 24, 2026 004
ODE-405 August 24, 2029 001
ODE-405 August 24, 2029 002
ODE-405 August 24, 2029 003
ODE-405 August 24, 2029 004
PED February 24, 2030 001
PED February 24, 2030 002
PED February 24, 2030 003
PED February 24, 2030 004

Approval history

Source: Drugs@FDA
Most recent submissions on application 210563.
Type No. Action Status Date Review
Supplement 20 Labeling Approved October 21, 2025 Standard
Supplement 19 Labeling Approved December 20, 2024 Standard
Supplement 18 Labeling Approved May 9, 2024 901 Required
Supplement 17 Efficacy Approved May 18, 2023 Standard
Supplement 14 Efficacy Approved August 24, 2022 Priority
Supplement 13 Efficacy Approved August 24, 2022 Priority
Supplement 12 Efficacy Approved August 24, 2022 Priority
Supplement 11 Labeling Approved May 11, 2022 Standard
Supplement 10 Labeling Approved December 22, 2020 Standard
Supplement 9 Efficacy Approved December 18, 2020 Standard
Supplement 7 Labeling Approved August 7, 2020 Standard
Supplement 6 Efficacy Approved April 21, 2020 Priority
Supplement 4 Labeling Approved November 21, 2019 Standard
Supplement 3 Labeling Approved July 15, 2019 Standard
Supplement 2 Efficacy Approved January 25, 2019 Priority
Supplement 1 Efficacy Approved August 24, 2018 Priority
Original application 2 Efficacy Approved February 16, 2018 Priority
Original application 1 Type 3 - New Dosage Form Approved February 16, 2018 Priority

Review documents

  • 0 · Supplement · October 31, 2025
  • 0 · Supplement · October 23, 2025
  • 0 · Supplement · December 26, 2024
  • 0 · Supplement · December 26, 2024
  • 0 · Supplement · May 14, 2024
  • 0 · Supplement · May 22, 2023
  • 0 · Supplement · May 19, 2023
  • 0 · Supplement · August 30, 2022
  • 0 · Supplement · August 25, 2022
  • 0 · Supplement · May 16, 2022
  • 0 · Supplement · May 16, 2022
  • 0 · Supplement · December 28, 2020
  • 0 · Supplement · December 28, 2020
  • 0 · Supplement · December 22, 2020
  • 0 · Supplement · December 22, 2020
  • 0 · Supplement · August 11, 2020
  • 0 · Supplement · August 10, 2020
  • 0 · Supplement · April 22, 2020
  • 0 · Supplement · April 21, 2020
  • 0 · Supplement · November 22, 2019
  • 0 · Supplement · November 22, 2019
  • 0 · Supplement · August 8, 2019
  • 0 · Supplement · July 16, 2019
  • 0 · Supplement · February 13, 2019
  • 0 · Supplement · January 29, 2019
  • 0 · Original application · October 26, 2018
  • 0 · Original application · October 26, 2018
  • 0 · Supplement · August 28, 2018
  • 0 · Supplement · August 28, 2018
  • 0 · Original application · May 17, 2018

Adverse event reports

Source: openFDA FAERS
80,310
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBRUTINIB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
57962-014-28 57962-014 Pharmacyclics LLC 1 BLISTER PACK in 1 CARTON (57962-014-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK February 16, 2018
57962-280-28 57962-280 Pharmacyclics LLC 1 BLISTER PACK in 1 CARTON (57962-280-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK February 16, 2018
57962-420-28 57962-420 Pharmacyclics LLC 1 BLISTER PACK in 1 CARTON (57962-420-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK February 16, 2018
57962-014 57962-014 Pharmacyclics LLC — February 16, 2018
57962-280 57962-280 Pharmacyclics LLC — February 16, 2018
57962-420 57962-420 Pharmacyclics LLC — February 16, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.