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Last Updated: July 4, 2020

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TASIGNA Drug Profile


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When do Tasigna patents expire, and what generic alternatives are available?

Tasigna is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-two patent family members in fifty-one countries.

The generic ingredient in TASIGNA is nilotinib hydrochloride. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Tasigna

Tasigna was eligible for patent challenges on October 29, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 7, 2032. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for TASIGNA
Drug Prices for TASIGNA

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Generic Entry Opportunity Date for TASIGNA
Generic Entry Date for TASIGNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TASIGNA

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

SponsorPhase
Ohio State University Comprehensive Cancer CenterPhase 1
National Institutes of Health (NIH)Phase 2
Plateforme labellisée Inca – Hôpital Européen Georges Pompidou, ParisPhase 3

See all TASIGNA clinical trials

Pharmacology for TASIGNA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for TASIGNA
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 TASIGNA

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 022068-001 Oct 29, 2007 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes   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 Y   Start Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Merck
Medtronic
Baxter
Harvard Business School

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.