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.

Summary for nilotinib hydrochloride

International Patents:	290
US Patents:	7
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	200
Patent Applications:	237
DailyMed Link:	nilotinib hydrochloride at DailyMed

Recent Clinical Trials for nilotinib hydrochloride

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

Sponsor	Phase
KeifeRx, LLC	Phase 3
Life Molecular Imaging GmbH	Phase 3
Augusta University	Phase 2

See all nilotinib hydrochloride clinical trials

Pharmacology for nilotinib hydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for nilotinib hydrochloride

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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		RX	Yes	No	⤷ 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
Apotex	NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	203640-002	Jan 5, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018		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

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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

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Country	Patent Number	Title	Estimated Expiration
Portugal	1912973		⤷ Sign Up
South Korea	20130077915	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
Norway	20050636		⤷ Sign Up
Guatemala	200600316	SALES DE 4-METILO-N-(3-(4-METILO-IMIDAZOL-1-ILO)-5-TRIFLUOROMETILO-FENILO)-3-(4-PIRIDINA-3-ILO-PIRIMIDINA-2-ILOAMINO)- BENZAMIDA.	⤷ Sign Up
Costa Rica	9657	CRYSTALINE 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
>Country	>Patent Number	>Title	>Estimated Expiration

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