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Last Updated: January 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 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 seventy-six 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
H. Jean Khoury Cure CML ConsortiumPhase 2
Sun Pharmaceuticals Industries LimitedPhase 3
KeifeRx, LLCPhase 3

See all nilotinib hydrochloride clinical trials

Generic filers with tentative approvals for NILOTINIB HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 200MG BASECAPSULE;ORAL
See Plans and PricingSee Plans and PricingEQ 150MG BASECAPSULE;ORAL
See Plans and PricingSee Plans and PricingEQ 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and 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 Title Estimated Expiration
Japan 2010504942 See Plans and Pricing
Russian Federation 2009115782 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ НИЛОТИНИБ ИЛИ ЕГО СОЛЬ See Plans and Pricing
Chile 2012001270 Compuesto 4-metil-n-[3-(4-metil-1h-imidazol-1-il)-5-(trifluorometil)fenil]-3-[(4-piridin-3-ilpirimidin-2-il)amino] benzamida (nilotinib) para el tratamiento de un trastorno proliferativo u otras condiciones mediadas por quinasa bcr-abl, c-kit, ddr1, ddr2 o pdgf-r, administrado oralmente dispersado en una compota de manzana. See Plans and Pricing
New Zealand 564182 Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide See Plans and Pricing
Malaysia 169956 METHOD OF TREATING PROLIFERATIVE DISORDERS AND OTHER PATHOLOGICAL CONDITIONS MEDIATED BY BCR-ABL, C-KIT, DDR1, DDR2 OR PDGF-R KINASE ACTIVITY See Plans and Pricing
Cyprus 1108813 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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AstraZeneca

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