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Last Updated: March 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 eighty-seven 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
H. Jean Khoury Cure CML ConsortiumPhase 2
Sun Pharmaceuticals Industries LimitedPhase 3
KeifeRx, LLCPhase 3

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

International Patents for nilotinib hydrochloride

Country Patent Number Title Estimated Expiration
New Zealand 564409 Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide hydrochloride ⤷  Try a Trial
Australia 2013211489 Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide ⤷  Try a Trial
China 101045727 Inhibitors of tyrosine kinases ⤷  Try a Trial
Hong Kong 1077811 INHIBITORS OF TYROSINE KINASES ⤷  Try a Trial
Malaysia 148237 PHARMACEUTICAL COMPOSITIONS COMPRISING NILOTINIB OR ITS SALT ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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