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Last Updated: March 30, 2023

Nilotinib hydrochloride - Generic Drug Details


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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 seventy-five 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.

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

Generic filers with tentative approvals for NILOTINIB HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 200MG BASECAPSULE;ORAL
⤷  Sign Up⤷  Sign UpEQ 150MG BASECAPSULE;ORAL
⤷  Sign Up⤷  Sign UpEQ 50MG BASECAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ⤷  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

International Patents for nilotinib hydrochloride

Country Patent Number Title Estimated Expiration
Taiwan 200740793 Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide ⤷  Sign Up
China 101045727 Inhibitors of tyrosine kinases ⤷  Sign Up
Hong Kong 1077811 INHIBITORS OF TYROSINE KINASES ⤷  Sign Up
Slovenia 2068839 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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McKinsey
Johnson and Johnson
Mallinckrodt
Moodys
Baxter

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