Is there a generic for Nilotinib hydrochloride?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Nilotinib hydrochloride, referencing the brand TASIGNA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Nilotinib hydrochloride?

TASIGNA (NDA 022068, NOVARTIS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Nilotinib hydrochloride?

The Orange Book lists 12 patents against Nilotinib hydrochloride products, with the earliest listed expiry in 2026. 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 Nilotinib hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 6 marketing-exclusivity periods for Nilotinib hydrochloride. 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 Nilotinib hydrochloride are approved?

Nilotinib hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Nilotinib hydrochloride

Nilotinib hydrochloride: 1 brand, 6 generics; first approved Oct 29, 2007; generic available.

Generic available6 exclusivity periods

Generic status & protection

Generic available: 6 ANDA applications approved.

Earliest patent expiry Jul 18, 2026Latest exclusivity ends Mar 23, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 18, 2026

17 d ago

Brand (NDA) products

Originator applications

TASIGNARLD
NOVARTISNDA 02206820183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
EQ 50MG BASE CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB

Generic (ANDA) products (6)

Abbreviated applications

NILOTINIB HYDROCHLORIDE
TEVA PHARMS INCANDA 21913420263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
EQ 200MG BASE CAPSULE ORAL Rx AB
NILOTINIB HYDROCHLORIDE
TORRENTANDA 21853220252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE CAPSULE ORAL Rx AB
EQ 200MG BASE CAPSULE ORAL Rx AB
NILOTINIB HYDROCHLORIDE
DR REDDYSANDA 21835020253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
EQ 200MG BASE CAPSULE ORAL Rx AB
NILOTINIB HYDROCHLORIDE
HETERO LABS LTD VANDA 20965120252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 150MG BASE CAPSULE ORAL Rx AB
EQ 200MG BASE CAPSULE ORAL Rx AB
NILOTINIB HYDROCHLORIDE
MSNANDA 21854420253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
EQ 200MG BASE CAPSULE ORAL Rx AB
NILOTINIB HYDROCHLORIDE
APOTEXANDA 20364020243 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
EQ 200MG BASE CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB
EQ 200MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB
EQ 200MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB
EQ 200MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB
EQ 200MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB
EQ 200MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB
EQ 200MG BASE	CAPSULE	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

ODE-380Orphan-drug exclusivity (7 years)
Sep 23, 2028
in 2 yr 2 mo
PEDPediatric exclusivity (adds 6 months)
Mar 23, 2029
in 2 yr 8 mo
ODE-380Orphan-drug exclusivity (7 years)
Sep 23, 2028
in 2 yr 2 mo
PEDPediatric exclusivity (adds 6 months)
Mar 23, 2029
in 2 yr 8 mo
ODE-380Orphan-drug exclusivity (7 years)
Sep 23, 2028
in 2 yr 2 mo
PEDPediatric exclusivity (adds 6 months)
Mar 23, 2029
in 2 yr 8 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
8389537	Jul 18, 2026	17 d ago	U-1374
8415363	Jul 18, 2026	17 d ago	SubstanceProductU-1407
8501760	Jul 18, 2026	17 d ago	Product
8415363*PED	Jan 18, 2027	in 6 mo
8389537*PED	Jan 18, 2027	in 6 mo
8501760*PED	Jan 18, 2027	in 6 mo
8293756	Sep 25, 2027	in 1 yr 2 mo	Product
8293756*PED	Mar 25, 2028	in 1 yr 8 mo
8163904	Aug 23, 2028	in 2 yr 1 mo	SubstanceProduct
8163904*PED	Feb 23, 2029	in 2 yr 7 mo
9061029	Apr 07, 2032	in 5 yr 9 mo	SubstanceU-1374
9061029*PED	Oct 07, 2032	in 6 yr 3 mo

Approval history

FDA approval span

First approval

Oct 29, 2007

19 yr ago

Most recent approval

Jun 26, 2026

1 mo ago

Approvals span 2007–2026 across 7 FDA applications.

Brand (NDA) 114%

Generic (ANDA) 686%

Nilotinib hydrochloride: 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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