Nilotinib hydrochloride - Generic Drug Details
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What are the generic sources for nilotinib hydrochloride and what is the scope of patent protection?
Nilotinib hydrochloride
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 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
International Patents: | 276 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 199 |
Patent Applications: | 286 |
Formulation / Manufacturing: | see details |
DailyMed Link: | nilotinib hydrochloride at DailyMed |
Recent Clinical Trials for nilotinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
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
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 200MG BASE | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 150MG BASE | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 50MG BASE | CAPSULE;ORAL |
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
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TASIGNA | Capsules | nilotinib hydrochloride | 50 mg | 022068 | 1 | 2019-10-17 |
TASIGNA | Capsules | nilotinib hydrochloride | 150 mg and 200 mg | 022068 | 1 | 2013-11-08 |
US Patents and Regulatory Information for nilotinib hydrochloride
International Patents for nilotinib hydrochloride
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 |
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