Is there a generic for Bosutinib monohydrate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Bosutinib monohydrate, referencing the brand BOSULIF. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Bosutinib monohydrate?

BOSULIF (NDA 217729, PF PRISM CV) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Bosutinib monohydrate?

The Orange Book lists 8 patents against Bosutinib monohydrate products, with the earliest listed expiry in 2025. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Bosutinib monohydrate have FDA marketing exclusivity?

Yes. The Orange Book records 20 marketing-exclusivity periods for Bosutinib monohydrate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Bosutinib monohydrate are approved?

Bosutinib monohydrate is approved in the following dosage forms: capsule, tablet.

FDA Orange Book · active-ingredient family

Bosutinib monohydrate

Bosutinib monohydrate: 2 brands, 2 generics; first approved Sep 04, 2012; generic available.

Generic available20 exclusivity periods

Generic status & protection

Generic available: 2 ANDA applications approved.

Earliest patent expiry Dec 11, 2025Latest exclusivity ends Mar 26, 2031

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 11, 2025

9 mo ago

Brand (NDA) products

Originator applications

BOSULIFRLD
PF PRISM CVNDA 21772920232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx —
EQ 100MG BASE CAPSULE ORAL Rx —
BOSULIFRLDRS
PF PRISM CVNDA 20334120123 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
EQ 500MG BASE TABLET ORAL Rx AB
EQ 400MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Rx	—
EQ 100MG BASE	CAPSULE	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 500MG BASE	TABLET	ORAL	Rx	AB
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Generic (ANDA) products (2)

Abbreviated applications

BOSUTINIB MONOHYDRATE
MSNANDA 2096242026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 400MG BASE TABLET ORAL Rx AB
BOSUTINIB MONOHYDRATE
ALEMBICANDA 20954320252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE TABLET ORAL Rx AB
EQ 500MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 400MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 500MG BASE	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPNew product exclusivity (3 years)
Sep 26, 2026
in 1 mo
ODE-444Orphan-drug exclusivity (7 years)
Sep 26, 2030
in 4 yr 2 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2031
in 4 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 7 mo
NPNew product exclusivity (3 years)
Sep 26, 2026
in 1 mo
ODE-444Orphan-drug exclusivity (7 years)
Sep 26, 2030
in 4 yr 2 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2031
in 4 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 7 mo
I-923New indication exclusivity (3 years)
Sep 26, 2026
in 1 mo
ODE-444Orphan-drug exclusivity (7 years)
Sep 26, 2030
in 4 yr 2 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2031
in 4 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 7 mo
I-923New indication exclusivity (3 years)
Sep 26, 2026
in 1 mo
ODE-444Orphan-drug exclusivity (7 years)
Sep 26, 2030
in 4 yr 2 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2031
in 4 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 7 mo
I-923New indication exclusivity (3 years)
Sep 26, 2026
in 1 mo
ODE-444Orphan-drug exclusivity (7 years)
Sep 26, 2030
in 4 yr 2 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2031
in 4 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 7 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7417148	Dec 11, 2025	9 mo ago	U-3707
7919625	Dec 11, 2025	9 mo ago	Product
7919625*PED	Jun 11, 2026	3 mo ago
7417148*PED	Jun 11, 2026	3 mo ago
7767678	Nov 23, 2026	in 3 mo	SubstanceProduct
7767678*PED	May 23, 2027	in 9 mo
11103497	Feb 28, 2034	in 7 yr 7 mo	U-3216
11103497*PED	Aug 28, 2034	in 8 yr 2 mo

Approval history

FDA approval span

First approval

Sep 04, 2012

14 yr 2 mo ago

Most recent approval

Jun 12, 2026

2 mo ago

Approvals span 2012–2026 across 4 FDA applications.

Brand (NDA) 250%

Generic (ANDA) 250%

Bosutinib monohydrate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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