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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Accenture
US Department of Justice
McKesson
Healthtrust

Generated: July 16, 2018

DrugPatentWatch Database Preview

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. 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 profile page.
Summary for TASIGNA
Drug patent expirations by year for TASIGNA
Generic Entry Opportunity Date for TASIGNA
Generic Entry Date for TASIGNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TASIGNA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein 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 CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for TASIGNA
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 150 mg and 200 mg ➤ Subscribe ➤ Try a Free Trial

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
7,569,566 Inhibitors of tyrosine kinases ➤ Try a Free Trial
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 ➤ Try a Free Trial
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 ➤ Try a Free Trial
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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Express Scripts
US Army
Moodys
QuintilesIMS
Baxter
Federal Trade Commission
Mallinckrodt
Julphar

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