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Last Updated: October 1, 2022

TYKERB Drug Patent Profile


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Which patents cover Tykerb, and what generic alternatives are available?

Tykerb is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-nine patent family members in twenty-seven countries.

The generic ingredient in TYKERB is lapatinib ditosylate. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lapatinib ditosylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tykerb

A generic version of TYKERB was approved as lapatinib ditosylate by NATCO PHARMA LTD on September 29th, 2020.

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Summary for TYKERB
Drug patent expirations by year for TYKERB
Drug Prices for TYKERB

See drug prices for TYKERB

Recent Clinical Trials for TYKERB

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

SponsorPhase
Aslan PharmaceuticalsPhase 2
University of Alabama at BirminghamN/A
AbbVieN/A

See all TYKERB clinical trials

Pharmacology for TYKERB
Drug ClassKinase Inhibitor
Mechanism of Action Protein Kinase Inhibitors
Paragraph IV (Patent) Challenges for TYKERB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TYKERB Tablets lapatinib ditosylate 250 mg 022059 1 2011-03-14

US Patents and Regulatory Information for TYKERB

TYKERB is protected by one US patents.

Patents protecting TYKERB

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: 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
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

Expired US Patents for TYKERB

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 See Plans and Pricing See Plans and Pricing
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 See Plans and Pricing See Plans and Pricing
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 See Plans and Pricing See Plans and Pricing
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TYKERB

When does loss-of-exclusivity occur for TYKERB?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4252
Estimated Expiration: See Plans and Pricing

Australia

Patent: 06236423
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0609962
Estimated Expiration: See Plans and Pricing

Canada

Patent: 06207
Estimated Expiration: See Plans and Pricing

China

Patent: 1203211
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0161429
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18179
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 71347
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0702253
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 71347
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 30982
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6336
Estimated Expiration: See Plans and Pricing

Japan

Patent: 02302
Estimated Expiration: See Plans and Pricing

Patent: 08536931
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 71347
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07013089
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 404
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2223
Estimated Expiration: See Plans and Pricing

Norway

Patent: 075111
Estimated Expiration: See Plans and Pricing

Peru

Patent: 061430
Estimated Expiration: See Plans and Pricing

Poland

Patent: 71347
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 71347
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 71347
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0708705
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1356748
Estimated Expiration: See Plans and Pricing

Patent: 080005557
Estimated Expiration: See Plans and Pricing

Spain

Patent: 01503
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 0716204
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TYKERB around the world.

Country Patent Number Title Estimated Expiration
Israel 153111 QUINAZOLINE DITOSYLATE SALT COMPOUNDS See Plans and Pricing
Yugoslavia 44800 See Plans and Pricing
Norway 20003561 See Plans and Pricing
Portugal 1454907 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TYKERB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1047694 CA 2008 00040 Denmark See Plans and Pricing PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
1047694 08C0038 France See Plans and Pricing PRODUCT NAME: LAPATINIB OU UN DE SES SELS OU PRODUITS DE SOLVATATION; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 PA 2008012, C1047694 Lithuania See Plans and Pricing PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 SZ 37/2008 Austria See Plans and Pricing PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Dow
Medtronic
Colorcon
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.