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Generated: November 21, 2018

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TASIGNA Drug Profile

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When do Tasigna patents expire, and what generic alternatives are available?

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.

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.

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
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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

International Patents for TASIGNA

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
Boehringer Ingelheim
Healthtrust
Argus Health
Covington
Daiichi Sankyo
Chubb
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.