➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Boehringer Ingelheim
Moodys
Baxter
Medtronic

Last Updated: August 10, 2020

DrugPatentWatch Database Preview

Nilotinib hydrochloride - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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-two patent family members in fifty-one countries.

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

Summary for nilotinib hydrochloride
Recent Clinical Trials for nilotinib hydrochloride

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

SponsorPhase
Hyewon ChungPhase 1
Zhongda HospitalPhase 4
Otsuka Beijing Research InstitutePhase 2

See all nilotinib hydrochloride clinical trials

Pharmacology for nilotinib hydrochloride
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for NILOTINIB HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
TASIGNA CAPSULE;ORAL nilotinib hydrochloride 022068 2019-10-17
TASIGNA CAPSULE;ORAL nilotinib hydrochloride 022068 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 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Johnson and Johnson
Mallinckrodt
Moodys
Baxter

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.