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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Teva
Farmers Insurance
Cantor Fitzgerald
Johnson and Johnson
AstraZeneca
Harvard Business School
Merck
Queensland Health

Generated: April 26, 2018

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Nilotinib hydrochloride monohydrate - Generic Drug Details

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What are the generic drug sources for nilotinib hydrochloride monohydrate and what is the scope of nilotinib hydrochloride monohydrate patent protection?

Nilotinib hydrochloride monohydrate
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nilotinib hydrochloride monohydrate has two hundred and sixty-two patent family members in fifty countries.

There are ten drug master file entries for nilotinib hydrochloride monohydrate. One supplier is listed for this compound.
Summary for nilotinib hydrochloride monohydrate
Pharmacology for nilotinib hydrochloride monohydrate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for nilotinib hydrochloride monohydrate
4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride hydrate
4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide hydrochloride hydrate
4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide monohydrochloride monohydrate
4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide;hydrate;hydrochloride
5JHU0N1R6K
923288-90-8
AC-28467
AK468724
AKOS027420462
AOB87113
Benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (1:1:1)
C28H22F3N7O.HCl.H2O
CF-0252
CHEMBL1201740
CS-1212
D06413
DTXSID00238967
FT-0700805
HE072054
HE416346
HY-10159A
KS-00000HOJ
MFCD18251359
MolPort-039-062-195
Nilotinib (monohydrochloride monohydrate)
Nilotinib HCl monohydrate
NILOTINIB HYDRATE HYDROCHLORIDE
Nilotinib hydrochloride hydrate
Nilotinib hydrochloride hydrate (JAN)
Nilotinib hydrochloride hydrate [JAN]
Nilotinib hydrochloride monohydrate [Orange Book]
Nilotinib monohydrochloride monohydrate
SC-82023
SCHEMBL235245
Tasigna (TN)
UNII-5JHU0N1R6K
X8407
YCBPQSYLYYBPDW-UHFFFAOYSA-N

US Patents and Regulatory Information for nilotinib hydrochloride monohydrate

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 022068-001 Oct 29, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Non-Orange Book US Patents for nilotinib hydrochloride monohydrate

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
8,343,984 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 ➤ Sign Up
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 ➤ Sign Up
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 ➤ Sign Up
7,569,566 Inhibitors of tyrosine kinases ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Daiichi Sankyo
Boehringer Ingelheim
Johnson and Johnson
QuintilesIMS
Baxter
Dow
Mallinckrodt

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.