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Nilotinib hydrochloride - Generic Drug Details
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 sixty-seven patent family members in fifty-one countries.
There are eleven drug master file entries for nilotinib hydrochloride. One supplier is listed for this compound.
Summary for nilotinib hydrochloride
International Patents: | 267 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 11 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 15 |
Clinical Trials: | 175 |
Patent Applications: | 79 |
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 |
---|---|
Milton S. Hershey Medical Center | Phase 1/Phase 2 |
National Institutes of Health (NIH) | Phase 2 |
Shenzhen Second People's Hospital | Phase 3 |
Pharmacology for nilotinib hydrochloride
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Synonyms for nilotinib hydrochloride
3929AH |
4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride |
4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide hydrochloride |
4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide;hydrochloride |
923288-95-3 |
ACN-055570 |
Benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride (1:1) |
C28H22F3N7O.ClH |
DTXSID60238968 |
K37N7BYX3X |
Nilotinib HCl |
Nilotinib hydrochloride anhydrous |
SCHEMBL434496 |
UNII-K37N7BYX3X |
VTGGYCCJUPYZSX-UHFFFAOYSA-N |
Paragraph IV (Patent) Challenges for NILOTINIB HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
TASIGNA | CAPSULE;ORAL | nilotinib hydrochloride | 022068 | 2019-10-17 |
TASIGNA | CAPSULE;ORAL | nilotinib hydrochloride | 022068 | 2013-11-08 |
US Patents and Regulatory Information for nilotinib hydrochloride
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 | 022068-002 | Jun 17, 2010 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-002 | Jun 17, 2010 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-002 | Jun 17, 2010 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for nilotinib hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Denmark | 1532138 | Start Trial |
Cyprus | 1108813 | Start Trial |
Cuba | 20120123 | Start Trial |
Tunisia | 2012000206 | Start Trial |
Russian Federation | 2348627 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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