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BOSULIF

NDA

BOSUTINIB MONOHYDRATE | N217729 | PF PRISM CV

2 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

Mar. 26, 2031

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$3716.37

Highest Price

$26070.30

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-0504-30BOSULIF 50MG CAP	$3716.37	Big4	Pfizer Inc.	06/30/2029
00069-0504-30BOSULIF 50MG CAP	$5214.06	FSS	Pfizer Inc.	06/30/2029
00069-1014-15BOSULIF 100MG TAB	$18504.64	Big4	Pfizer Inc.	06/30/2029
00069-1014-15BOSULIF 100MG TAB	$26070.30	FSS	Pfizer Inc.	06/30/2029

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

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

3 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2026	SUPPL -2	View Letter (PDF)
Dec 4, 2024	SUPPL -1	View Letter (PDF)
Sep 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 50MG BASE

RLD

6 patents4 exclusivities▴

CAPSULE;ORAL | Approved: Sep 26, 2023

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7417148	Dec 11, 2025PED: Jun 11, 2026	PED	—	—		—
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	—	—		—
11103497	Feb 28, 2034PED: Aug 28, 2034	PED	—	—		—

Exclusivities (4)

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

#002 — EQ 100MG BASE

RLD

6 patents4 exclusivities▾

CAPSULE;ORAL | Approved: Sep 26, 2023