Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2015-01076	8754090Delisted	IPR	Coalition for Affordable Drugs IV LLC	Institution Denied	2015-04-20	—
IPR2019-00865	9795604	IPR	Sandoz Inc. et al.	Final Written Decision	2019-03-21	—
PGR2024-00009	11672803	PGR	BeiGene USA, Inc. et al.	Final Written Decision	2023-11-01	2025-05-01

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

6 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Pharmacyclics LLC v. BeOne Medicines USA, Inc. et al 1:2023cv00646 6 patentsibrutinib (IMBRUVICA®); zanubrutinib (BRUKINSA®)	D. Del.	2023-06-13	Terminated 2025-09-30	—
Pharmacyclics LLC et al v. Alvogen Pine Brook, LLC et al 1:2020cv00403 1 patentANDA 211319, 211344, 211267, 212763ibrutinib	D. Del.	2020-03-20	Terminated 2021-04-13	—
Pharmacyclics LLC et al v. Zydus Worldwide DMCC et al 1:2019cv00143 15 patentsANDA 211344ibrutinib	D. Del.	2019-01-28	Terminated 2021-05-11	—
Pharmacyclics LLC et al v. Hetero USA Inc. et al 1:2018cv01778 5 patentsANDA 211182ibrutinib	D. Del.	2018-11-12	Terminated 2019-02-12	—
Pharmacyclics LLC et al v. Sun Pharma Global FZE et al 1:2018cv01543 1 patentANDA 211319ibrutinib	D. Del.	2018-10-05	Terminated 2020-05-26	—
Pharmacyclics LLC et al v. Sandoz Inc. et al 1:2018cv00192 15 patentsANDA 210896ibrutinib	D. Del.	2018-02-01	Terminated 2021-05-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Economic Analysis of Alliance A041202 CLL Study NCT02414022	—	Active	Canadian Cancer Trials Group	55	2015-04-15 → 2026-12-31
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)NCT06136559	Phase 3	Recruiting	Merck Sharp & Dohme LLC	1,200	2023-12-13 → 2032-09-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Imbruvica (2023)

Total Spending

$2.4B

Total Claims

152,032

Beneficiaries

17,100

Avg Cost/Unit

$486.63

Spending Trend

$2.4B(2019)→$3.0B(2020)→$3.2B(2021)→$2.9B(2022)→$2.4B(2023)

YoY Change:+5.8%

5yr CAGR:+7.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain23 active DMFs2 inactive

17 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDIBRUTINIB (AMORPHOUS)

DMF 305572016

WAVELENGTH ENTERPRISES LTDIBRUTINIB

DMF 307462016

MSN LABORATORIES PRIVATE LTDIBRUTINIB (FORM-A)

DMF 307592016

SCINOPHARM TAIWAN LTDIBRUTINIB

DMF 309252016

SUN PHARMACEUTICAL INDUSTRIES LTDIBRUTINIB (FORM S4)

DMF 315472017

TAPI NL BVIBRUTINIB

DMF 316312017

ESTEVE HUAYI PHARMACEUTICAL CO LTDIBRUTINIB

DMF 316792017

HETERO LABS LTDIBRUTINIB (FORM-A)

DMF 316892017

DR REDDYS LABORATORIES LTDIBRUTINIB

DMF 317922017

WISDOM PHARMACEUTICAL CO LTDIBRUTINIB

DMF 319172017

SHILPA PHARMA LIFESCIENCES LTDIBRUTINIB

DMF 321222017

ALEMBIC PHARMACEUTICALS LTDIBRUTINIB

DMF 328802018

NATCO PHARMA LTDIBRUTINIB (IBN)

DMF 329372018

MSN LABORATORIES PRIVATE LTDIBRUTINIB (FORM C)

DMF 333572018

MSN LABORATORIES PRIVATE LTDIBRUTINIB (FORM-M5)

DMF 347682020

BEIJING HOPE PHARMACEUTICAL CO LTDIBRUTINIB

DMF 370002022

DR REDDYS LABORATORIES LTDIBRUTINIB (FORM-A)

DMF 373112022

WISDOM PHARMACEUTICAL CO LTDIBRUTINIB INTERMEDIATE

DMF 374732022

WISDOM PHARMACEUTICAL CO LTDIBRUTINIB

DMF 389192023

CDYMAX (INDIA) PHARMA PRIVATE LTDIBRUTINIB (FORM-A)

DMF 402282024

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDIBRUTINIB

DMF 407942024

SYNTHIMED LABS PRIVATE LTDIBRUTINIB

DMF 413892025

SICHUAN KELUN PHARMACEUTICAL CO LTDIBRUTINIB

DMF 426902025

FRESENIUS KABI ONCOLOGY LTDInactiveIBRUTINIB

DMF 311992017

CIPLA LTDInactiveIBRUTINIB

DMF 317282017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

26 letters from Drugs@FDA

Date	Submission	Document
Oct 23, 2025	SUPPL -44	View Letter (PDF)
Dec 26, 2024	SUPPL -43	View Letter (PDF)
May 10, 2024	SUPPL -42	View Letter (PDF)
May 10, 2024	SUPPL -18	View Letter (PDF)
May 10, 2024	SUPPL -3	View Letter (PDF)
May 19, 2023	SUPPL -40	View Letter (PDF)
May 12, 2022	SUPPL -35	View Letter (PDF)
Dec 28, 2020	SUPPL -33	View Letter (PDF)
Dec 22, 2020	SUPPL -32	View Letter (PDF)
Aug 10, 2020	SUPPL -31	View Letter (PDF)
Apr 22, 2020	SUPPL -30	View Letter (PDF)
Nov 22, 2019	SUPPL -29	View Letter (PDF)
Jul 16, 2019	SUPPL -28	View Letter (PDF)
Feb 13, 2019	SUPPL -26	View Letter (PDF)
Aug 28, 2018	SUPPL -25	View Letter (PDF)
Aug 28, 2018	SUPPL -24	View Letter (PDF)
Dec 27, 2017	SUPPL -20	View Letter (PDF)
Aug 4, 2017	SUPPL -17	View Letter (PDF)
Jan 24, 2017	SUPPL -16	View Letter (PDF)
Jun 29, 2016	SUPPL -12	View Letter (PDF)
May 9, 2016	SUPPL -10	View Letter (PDF)
Mar 8, 2016	SUPPL -7	View Letter (PDF)
Jan 29, 2015	SUPPL -2	View Letter (PDF)
Jul 29, 2014	SUPPL -1	View Letter (PDF)
Feb 14, 2014	ORIG -2	View Letter (PDF)
Nov 15, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 140MG

RLD

34 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Nov 13, 2013

Patents (34)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7514444	Dec 28, 2026PED: Jun 28, 2027	PED	Yes	Yes	—	—
8008309	Nov 13, 2027PED: May 13, 2028	PED	Yes	Yes	—	—
8476284	Dec 28, 2026PED: Jun 28, 2027	PED	—	—		—
8497277	Dec 28, 2026PED: Jun 28, 2027	PED	—	—		—
8563563	Apr 26, 2027PED: Oct 26, 2027	PED	—	—		—
8697711	Dec 28, 2026PED: Jun 28, 2027	PED	Yes	Yes	—	—
8703780	Dec 28, 2026PED: Jun 28, 2027	PED	—	—		—
8735403	Dec 28, 2026PED: Jun 28, 2027	PED	Yes	Yes	—	—
8754091	Dec 28, 2026PED: Jun 28, 2027	PED	—	Yes	—	—
8952015	Dec 28, 2026PED: Jun 28, 2027	PED	—	—		—
8957079	Dec 28, 2026PED: Jun 28, 2027	PED	Yes	Yes	—	—
8999999	Jun 3, 2031PED: Dec 3, 2031	PED	—	—		—
9125889	Jun 3, 2031PED: Dec 3, 2031	PED	—	—		—
9181257	Dec 28, 2026PED: Jun 28, 2027	PED	Yes	Yes	—	—
9296753	Oct 30, 2033PED: Apr 30, 2034	PED	Yes	Yes	—	—
9540382	Aug 18, 2033PED: Feb 18, 2034	PED	—	—		—
9713617	Jun 3, 2033PED: Dec 3, 2033	PED	—	Yes	—	—
9725455	Jun 3, 2033PED: Dec 3, 2033	PED	Yes	—	—	—
9795604	Oct 24, 2034PED: Apr 24, 2035	PED	—	—		—
9801881	Jun 3, 2031PED: Dec 3, 2031	PED	—	—		—
9801883	Jun 3, 2031PED: Dec 3, 2031	PED	—	—		—
10004746	Jun 3, 2031PED: Dec 3, 2031	PED	—	—		—
10016435	Jun 3, 2031PED: Dec 3, 2031	PED	—	—		—
10106548	Jun 3, 2033PED: Dec 3, 2033	PED	Yes	Yes	—	—
10125140	Jun 3, 2033PED: Dec 3, 2033	PED	Yes	Yes	—	—
10294231	Jun 3, 2033PED: Dec 3, 2033	PED	—	Yes	—	—
10294232	Jun 3, 2033PED: Dec 3, 2033	PED	—	Yes	—	—
10463668	Oct 24, 2034PED: Apr 24, 2035	PED	—	—		—
10478439	Jun 3, 2031PED: Dec 3, 2031	PED	—	—		—
10695350	Oct 24, 2034PED: Apr 24, 2035	PED	—	—		—
10751342	Jun 3, 2031PED: Dec 3, 2031	PED	—	—		—
10752634	Jun 3, 2033PED: Dec 3, 2033	PED	—	Yes	—	—
10961251	Jun 3, 2033PED: Dec 3, 2033	PED	—	Yes	—	—
11672803	Jun 3, 2031	—	—	—		—

Exclusivities (3)

Code	Date	Status
NPP	Aug 24, 2025	Expired
ODE-405	Aug 24, 2029	Active
PED	Feb 24, 2030	Active

#002 — 70MG

RLD

33 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Dec 20, 2017