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Nilotinib hydrochloride - Generic Drug Details
What are the generic sources for nilotinib hydrochloride and what is the scope of freedom to operate?
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 |
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 | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-002 | Jun 17, 2010 | RX | Yes | No | See Pricing | See Pricing | See Pricing | ||||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-003 | Mar 22, 2018 | RX | Yes | No | See Pricing | See Pricing | Y | See Pricing | |||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-003 | Mar 22, 2018 | RX | Yes | No | See Pricing | See Pricing | Y | See Pricing | |||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| >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 |
|---|---|---|
| Slovenia | 1532138 | See Pricing |
| Norway | 20080820 | See Pricing |
| Tunisia | SN08028 | See Pricing |
| Austria | 514689 | See Pricing |
| Serbia | 55929 | See Pricing |
| Guatemala | 200600315 | See Pricing |
| Jordan | 3308 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.