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BOSULIF

NDA

BOSUTINIB MONOHYDRATE | N203341 | PF PRISM CV

3 strengths4 unique patents4 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Expired (2)Expiring < 1yr (1)Active (1)TodayPED (+6 mo)Exclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Jun. 11, 2026

May. 23, 2027

Jun. 11, 2026

Aug. 28, 2034

I-923

Mar. 26, 2027

ODE-444

Mar. 26, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Wyeth LLC et al v. Sun Pharmaceutical Industries Limited 1:2017cv01362	D. Del.	2017-09-28	Terminated 2019-11-01	—
Wyeth LLC et al v. MSN Laboratories Private Limited et al 1:2017cv00233	D. Del.	2017-03-07	Terminated 2017-09-21	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

19 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia NCT03654768	Phase 2	Active	SWOG Cancer Research Network	81	2018-10-24 → 2028-07-01
Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)NCT03297606	Phase 2	Recruiting	Canadian Cancer Trials Group	720	2018-03-23 → 2027-01-31
Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors NCT03023319	Phase 1	Completed	Nagla Abdel Karim	6	2019-12-10 → 2022-05-10
Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)NCT00914121	Phase 1	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	60	2009-06 → 2009-08
Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects NCT00777530	Phase 1	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	48	2008-04 → 2008-08
The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)NCT02269267	Phase 2	Completed	Medical College of Wisconsin	173	2014-12-18 → 2022-04-06
Drug Interaction Study Between Bosutinib And Dabigatran NCT02102633	Phase 1	Completed	Pfizer	27	2014-05 → 2014-06
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML NCT00574873	Phase 3	Completed	Pfizer	502	2008-02-05 → 2015-05-27
Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects NCT00952913	Phase 1	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	24	2009-08 → 2009-10
A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia NCT02130557	Phase 3	Completed	Pfizer	536	2014-07-15 → 2020-04-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$14503.28

Highest Price

$21175.46

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-0136-01BOSULIF 500MG TAB	$21175.46	FSS	Pfizer Inc.	06/30/2029
00069-0136-01BOSULIF 500MG TAB	$14503.28	Big4	Pfizer Inc.	06/30/2029
00069-0135-01BOSULIF 100MG TAB	$21175.46	FSS	Pfizer Inc.	06/30/2029
00069-0135-01BOSULIF 100MG TAB	$14575.49	Big4	Pfizer Inc.	06/30/2029
00069-0193-01BOSULIF 400MG TAB	$21175.46	FSS	Pfizer Inc.	06/30/2029
00069-0193-01BOSULIF 400MG TAB	$14552.41	Big4	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Bosulif (2024)

Total Spending

$235.3M

Total Claims

15,541

Beneficiaries

1,981

Avg Cost/Unit

$357.00

Spending Trend

$95.8M(2019)→$123.4M(2020)→$147.7M(2021)→$170.0M(2022)→$199.1M(2023)→$235.3M(2024)

YoY Change:-3.4%

5yr CAGR:+5.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs

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

MSN LABORATORIES PRIVATE LTDBOSUTINIB [ROUTE CODE BS]

DMF 302182016

ALEMBIC PHARMACEUTICALS LTDBOSUTINIB

DMF 305522016

MSN LABORATORIES PRIVATE LTDBOSUTINIB MONOHYDRATE (FORM-I)

DMF 306832016

ALP PHARM BEIJING CO LTDBOSUTINIB

DMF 312182016

SUN PHARMACEUTICAL INDUSTRIES LTDBOSUTINIB

DMF 361212021

HETERO LABS LTDBOSUTINIB MONOHYDRATE

DMF 393802024

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

Approval Letters

19 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2026	SUPPL -27	View Letter (PDF)
Dec 4, 2024	SUPPL -26	View Letter (PDF)
Sep 27, 2023	SUPPL -25	View Letter (PDF)
Apr 21, 2023	SUPPL -24	View Letter (PDF)
May 17, 2021	SUPPL -20	View Letter (PDF)
Jun 18, 2020	SUPPL -18	View Letter (PDF)
Oct 10, 2019	SUPPL -17	View Letter (PDF)
Aug 15, 2019	SUPPL -16	View Letter (PDF)
Oct 23, 2018	SUPPL -15	View Letter (PDF)
May 3, 2018	SUPPL -13	View Letter (PDF)
Dec 27, 2017	SUPPL -9	View Letter (PDF)
Apr 14, 2017	SUPPL -8	View Letter (PDF)
Apr 14, 2017	SUPPL -7	View Letter (PDF)
Nov 18, 2016	SUPPL -6	View Letter (PDF)
Apr 6, 2016	SUPPL -5	View Letter (PDF)
Sep 24, 2015	SUPPL -3	View Letter (PDF)
Nov 28, 2014	SUPPL -2	View Letter (PDF)
Oct 1, 2013	SUPPL -1	View Letter (PDF)
Sep 6, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 100MG BASE

RLDAB

4 patents4 exclusivities▴

TABLET;ORAL | Approved: Sep 4, 2012

Patents (4) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7417148	Dec 11, 2025PED: Jun 11, 2026	PED	—	—		—
7767678	Nov 23, 2026PED: May 23, 2027	PED	Yes	Yes	—	—
7919625	Dec 11, 2025PED: Jun 11, 2026	PED	—	Yes	—	—
11103497	Feb 28, 2034PED: Aug 28, 2034	PED	—	—		—

Exclusivities (4)

Code	Date	Status
I-923	Sep 26, 2026	< 1 year
ODE-444	Sep 26, 2030	Active
PED	Mar 26, 2027	< 1 year
PED	Mar 26, 2031	Active

#002 — EQ 500MG BASE

RLDAB

4 patents4 exclusivities▾

TABLET;ORAL | Approved: Sep 4, 2012

#003 — EQ 400MG BASE

RLD

4 patents4 exclusivities▾

TABLET;ORAL | Approved: Oct 27, 2017