✉ Email this page to a colleague
« Back to Dashboard
▶ Start for $1
Remove trial restrictions
Nilotinib hydrochlorideis 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 has two hundred and seventy-six patent family members in fifty-one countries.
There are seven drug master file entries for nilotinib hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for nilotinib hydrochloride
|Drug Master File Entries:||7|
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||34|
|Formulation / Manufacturing:||see details|
|DailyMed Link:||nilotinib hydrochloride at DailyMed|
Recent Clinical Trials for nilotinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|H. Jean Khoury Cure CML Consortium||Phase 2|
|Sun Pharmaceuticals Industries Limited||Phase 3|
|KeifeRx, LLC||Phase 3|
Generic filers with tentative approvals for NILOTINIB HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for nilotinib hydrochloride
|Drug Class|| Kinase Inhibitor |
|Mechanism of Action||Bcr-Abl Tyrosine Kinase Inhibitors |
Cytochrome P450 2B6 Inducers
Cytochrome P450 2C8 Inducers
Cytochrome P450 2C8 Inhibitors
Cytochrome P450 2D6 Inhibitors
|Country||Patent Number||Title||Estimated Expiration|
|Japan||2010504942||See Plans and Pricing|
|Russian Federation||2009115782||ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ НИЛОТИНИБ ИЛИ ЕГО СОЛЬ||See Plans and Pricing|
|Chile||2012001270||Compuesto 4-metil-n-[3-(4-metil-1h-imidazol-1-il)-5-(trifluorometil)fenil]-3-[(4-piridin-3-ilpirimidin-2-il)amino] benzamida (nilotinib) para el tratamiento de un trastorno proliferativo u otras condiciones mediadas por quinasa bcr-abl, c-kit, ddr1, ddr2 o pdgf-r, administrado oralmente dispersado en una compota de manzana.||See Plans and Pricing|
|New Zealand||564182||Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide||See Plans and Pricing|
|Malaysia||169956||METHOD OF TREATING PROLIFERATIVE DISORDERS AND OTHER PATHOLOGICAL CONDITIONS MEDIATED BY BCR-ABL, C-KIT, DDR1, DDR2 OR PDGF-R KINASE ACTIVITY||See Plans and Pricing|
|Cyprus||1108813||See Plans and Pricing|
|>Country||>Patent Number||>Title||>Estimated Expiration|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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 verification 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.