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TASIGNA

NDA

NILOTINIB HYDROCHLORIDE | N022068 | NOVARTIS PHARMACEUTICALS CORP

3 strengths6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (3)Active (3)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

2031

2032

2033

Today

Feb. 23, 2029

Mar. 25, 2028

Jan. 18, 2027

Jan. 18, 2027

Jan. 18, 2027

Oct. 7, 2032

ODE-380

Mar. 23, 2029

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
Novartis Pharmaceuticals Corporation et al v. Eugia Pharma Specialities Ltd. et al 1:2025cv00800 6 patentsANDA 220516Nilotinib hydrochloride	D. Del.	2025-06-27	Terminated 2025-07-15	—
Novartis Pharmaceuticals Corporation et al v. Cipla Limited et al 1:2025cv00216 1 patentnilotinib d-tartrate	D. Del.	2025-02-21	Terminated 2025-03-11	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tasigna (2023)

Total Spending

$394.7M

Total Claims

24,550

Beneficiaries

2,961

Avg Cost/Unit

$173.99

Spending Trend

$318.6M(2019)→$339.5M(2020)→$352.2M(2021)→$376.0M(2022)→$394.7M(2023)

YoY Change:+10.1%

5yr CAGR:+8.4%

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

API Supply Chain15 active DMFs3 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDNILOTINIB HYDROCHLORIDE

DMF 281022014

DR REDDYS LABORATORIES LTDNILOTINIB HYDROCHLORIDE

DMF 300882015

HETERO LABS LTDNILOTINIB HYDROCHLORIDE DIHYDRATE

DMF 300982015

SUZHOU LIXIN PHARMACEUTICAL CO LTDNILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 316932017

MSN LABORATORIES PRIVATE LTDNILOTINIB HYDROCHLORIDE (MONOHYDRATE)

DMF 326612018

MSN LABORATORIES PRIVATE LTDNILOTINIB

DMF 331962018

TEVA PHARMACEUTICAL INDUSTRIES LTDNILOTINIB HYDROCHLORIDE FORM ALPHA

DMF 348742020

MSN LABORATORIES PRIVATE LTDNILOTINIB HYDROCHLORIDE SESQUIHYDRATE

DMF 357292021

SHILPA PHARMA LIFESCIENCES LTDNILOTINIB

DMF 362892021

NATCO PHARMA LTDNILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 363082022

DR REDDYS LABORATORIES LTDNILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 371612022

GRANULES INDIA LTD (UNIT-V)NILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 375312022

SICHUAN ELIXIR PHARMACEUTICAL CO LTDNILOTINIB

DMF 396482024

SHANDONG LIXIN PHARMACEUTICAL CO LTDNILOTINIB HYDROCHLORIDE MONOHYDRATE

DMF 400142024

MSN LABORATORIES PRIVATE LTDNILOTINIB HYDROCHLORIDE (MONOHYDRATE) [ROUTE CODE NPH]

DMF 413182025

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveNILOTINIB HYDROCHLORIDE MONOHYDRATE (FORM B) (VERSION NO.: 1)

DMF 253382011

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveNILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1)

DMF 254122011

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveNILOTINIB

DMF 264972012

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

Approval Letters

32 letters from Drugs@FDA

Date	Submission	Document
Aug 22, 2024	SUPPL -42	View Letter (PDF)
Mar 1, 2024	SUPPL -40	View Letter (PDF)
Feb 9, 2024	SUPPL -41	View Letter (PDF)
Oct 3, 2023	SUPPL -37	View Letter (PDF)
Sep 27, 2021	SUPPL -35	View Letter (PDF)
Sep 27, 2021	SUPPL -36	View Letter (PDF)
Dec 9, 2020	SUPPL -33	View Letter (PDF)
Sep 26, 2019	SUPPL -31	View Letter (PDF)
Aug 24, 2018	SUPPL -29	View Letter (PDF)
Mar 21, 2018	SUPPL -27	View Letter (PDF)
Dec 29, 2017	SUPPL -26	View Letter (PDF)
Feb 23, 2017	SUPPL -24	View Letter (PDF)
Sep 28, 2016	SUPPL -23	View Letter (PDF)
Oct 16, 2015	SUPPL -21	View Letter (PDF)
Jan 28, 2015	SUPPL -20	View Letter (PDF)
Sep 29, 2014	SUPPL -19	View Letter (PDF)
Jan 23, 2014	SUPPL -17	View Letter (PDF)
Oct 1, 2013	SUPPL -18	View Letter (PDF)
Jun 13, 2013	SUPPL -14	View Letter (PDF)
May 28, 2013	SUPPL -16	View Letter (PDF)
May 22, 2013	SUPPL -13	View Letter (PDF)
Dec 26, 2012	SUPPL -11	View Letter (PDF)
May 3, 2012	SUPPL -12	View Letter (PDF)
Nov 22, 2011	SUPPL -8	View Letter (PDF)
Nov 22, 2011	SUPPL -9	View Letter (PDF)
Nov 1, 2011	SUPPL -7	View Letter (PDF)
Jan 20, 2011	SUPPL -6	View Letter (PDF)
Jun 22, 2010	SUPPL -4	View Letter (PDF)
Jun 22, 2010	SUPPL -5	View Letter (PDF)
Mar 18, 2010	SUPPL -1	View Letter (PDF)
Jan 21, 2010	SUPPL -2	View Letter (PDF)
Nov 8, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 200MG BASE

RLDAB

6 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Oct 29, 2007

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8163904	Aug 23, 2028PED: Feb 23, 2029	PED	Yes	Yes	—	—
8293756	Sep 25, 2027PED: Mar 25, 2028	PED	—	Yes	—	—
8389537	Jul 18, 2026PED: Jan 18, 2027	PED	—	—		—
8415363	Jul 18, 2026PED: Jan 18, 2027	PED	Yes	Yes		—
8501760	Jul 18, 2026PED: Jan 18, 2027	PED	—	Yes	—	—
9061029	Apr 7, 2032PED: Oct 7, 2032	PED	Yes	—		—

Exclusivities (2)

Code	Date	Status
ODE-380	Sep 23, 2028	Active
PED	Mar 23, 2029	Active

#002 — EQ 150MG BASE

RLDAB

6 patents2 exclusivities▾

CAPSULE;ORAL | Approved: Jun 17, 2010

#003 — EQ 50MG BASE

RLDAB

6 patents2 exclusivities▾

CAPSULE;ORAL | Approved: Mar 22, 2018