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TASIGNA Drug Profile

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Which patents cover Tasigna, and when can generic versions of Tasigna launch?

Tasigna is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and sixty-two patent family members in fifty countries.

The generic ingredient in TASIGNA is nilotinib hydrochloride monohydrate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib hydrochloride monohydrate profile page.

Summary for TASIGNA

International Patents:	262
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	92
Clinical Trials:	53
Patent Applications:	3,414
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	TASIGNA at DailyMed

Pharmacology for TASIGNA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for TASIGNA

139316-EP2270008A1

139316-EP2292617A1

3gp0

4-?METHYL-?N-?[3-?(4-?METHYL-?1H-?IMIDAZOL-?1-?YL)-?5-?(TRIFLUOROMETHYL)PHENYL]-?3-?[[4-?(3-?PYRIDINYL)-?2-?PYRIMIDINYL]AMINO]-?BENZAMIDE

4-Methyl-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-N-(5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl)benzamide

4-Methyl-3-(4-(3-pyridinyl)-2-pyrimidinyl)amino)-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide

4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazo

4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide

4-Methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)-phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide

4-Methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2

4-Methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide

4-Methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(4-(pyridin-3-yl)pyrimidin-2-ylamino)benzamide

4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-{(4-(pyridin-3-yl)pyrimidin-2-yl)amino}benzamide

4-Methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide

4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide

4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide

4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide

4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-{[4-(pyridin-3-yl)pyrimidin-2-yl]amino}benzamide

4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide

4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide

4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridyl)pyrimidin-2-yl]amino]benzamide

4-Methyl-N-[3-(4-methylimidazol-1-yl)-5-trifluoromethylphenyl]-3-[[4-(pyridin-3-yl)pyrimidin-2-yl]amino]benzamide

49312-EP2270008A1

49312-EP2292617A1

49312-EP2305667A2

49312-EP2311840A1

571N100

641571-10-0

78680-EP2305667A2

AB0007991

AB01273978_03

AB01273978-01

AB01273978-02

ABP000478

AK-59889

AM20090651

AMN 107

AMN-107

AMN107

AN-5308

ANW-41982

AOB87115

API0003575

AS-16214

AX8144766

BC224537

BCP9000989

BCPP000149

BDBM50237710

benzamide, 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-

Benzamide, 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-(9CI)

BR-59889

C28H22F3N7O

cc-353

CHEBI:52172

CHEMBL255863

CS-0102

CTK8B3214

D00STL

D06GGT

DTXSID5042663

F41401512X

FC0027

FT-0654026

GP5854

GTPL5697

HE071162

HE141763

HHZIURLSWUIHRB-UHFFFAOYSA-N

HMS3244A13

HMS3244A14

HMS3244B13

HMS3654M07

HSDB 7842

HY-10159

I01-1225

KS-00000GT9

l-1-yl)-3-(trifluoromethyl)phenyl]benzamide

MCL-1-specific antisense oligonucleotide + nilotinib (AMN107)

MFCD09833716

MLS003915611

MLS006010160

MolPort-003-987-089

N-8207

NCGC00183285-01

NCGC00183285-03

NCGC00183285-04

NIL

Nilotinib

Nilotinib (AMN-107)

Nilotinib (BCR-ABL inhibitor 2nd gen)

Nilotinib (INN/USAN)

Nilotinib (USAN/INN)

Nilotinib [USAN:INN:BAN]

Nilotinib & its intermediates

Nilotinib hydrochloride hydrate

Nilotinib, AMN107, Tasigna

Nilotinib,AMN107,Tasigna;4-methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide

Nilotinib;

Nilotinib(AMN-107)

Nilotinib/

nilotinibum

NSC-747599

NSC747599

P111010

PubChem18272

Q-101348

QCR-112

RS0102

RTX-011143

S-6060

s1033

SC-19640

SCHEMBL7901

SMR002544680

SR-01000931150

SR-01000931150-2

ST2413627

SYN1057

Tasigna (Novartis)

Tasigna, AMN-107, Nilotinib

UNII-F41401512X

V0705

ZINC6716957

US Patents and Regulatory Information for TASIGNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TASIGNA	nilotinib hydrochloride monohydrate	CAPSULE;ORAL	022068-003	Mar 22, 2018		RX	Yes	No
Novartis	TASIGNA	nilotinib hydrochloride monohydrate	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride monohydrate	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes
Novartis	TASIGNA	nilotinib hydrochloride monohydrate	CAPSULE;ORAL	022068-002	Jun 17, 2010		RX	Yes	No					Y

Paragraph IV (Patent) Challenges for TASIGNA

Drugname	Dosage	Strength	RLD	Submissiondate
	Capsules	150 mg and 200 mg		2013-01-29

Non-Orange Book US Patents for TASIGNA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,580,806	Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide
9,163,005	Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
7,569,566	Inhibitors of tyrosine kinases
8,343,984	Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide

International Patents for TASIGNA

Country	Document Number	Estimated Expiration
South Korea	20130085444
Serbia	54747
Taiwan	200740793
Israel	165977