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Last Updated: May 29, 2024

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 two branded drugs marketed by Apotex and Novartis, and is included in two NDAs. 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 ninety patent family members in fifty-two countries.

There are seven drug master file entries for nilotinib hydrochloride. One supplier is listed for this compound.

Recent Clinical Trials for nilotinib hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
KeifeRx, LLCPhase 3
Life Molecular Imaging GmbHPhase 3
Augusta UniversityPhase 2

See all nilotinib hydrochloride clinical trials

Paragraph IV (Patent) Challenges 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

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 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for nilotinib hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 ⤷  Sign Up ⤷  Sign Up
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 ⤷  Sign Up ⤷  Sign Up
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-002 Jun 17, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for nilotinib hydrochloride

Country Patent Number Title Estimated Expiration
Taiwan I540128 ⤷  Sign Up
Morocco 29626 FORMES CRISTALLINES DE 4-METHYL-N-[3-(4-METHYL -IMIDAZOL-1-YL)-5-TRIFLUROMETHYL-PHENYL]-3-(4- PYRIDIN-3-YL-PYRIMIDIN-2-YLAMINO)-BENZAMIDE ⤷  Sign Up
Japan 5567340 ⤷  Sign Up
>Country >Patent Number >Title >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 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.