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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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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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.