Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Johnson and Johnson
McKesson
Merck
McKinsey

Last Updated: November 30, 2022

Lapatinib ditosylate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic drug sources for lapatinib ditosylate and what is the scope of freedom to operate?

Lapatinib ditosylate is the generic ingredient in two branded drugs marketed by Natco Pharma Ltd and Novartis, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lapatinib ditosylate has twenty-nine patent family members in twenty-seven countries.

There are six drug master file entries for lapatinib ditosylate. Two suppliers are listed for this compound.

Recent Clinical Trials for lapatinib ditosylate

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

SponsorPhase
Stanford UniversityPhase 2
Jonsson Comprehensive Cancer CenterPhase 1/Phase 2
Washington University School of MedicinePhase 2

See all lapatinib ditosylate clinical trials

Pharmacology for lapatinib ditosylate
Drug ClassKinase Inhibitor
Mechanism of Action Protein Kinase Inhibitors
Paragraph IV (Patent) Challenges for LAPATINIB DITOSYLATE
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 lapatinib ditosylate

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
Natco Pharma Ltd LAPATINIB DITOSYLATE lapatinib ditosylate TABLET;ORAL 203007-001 Sep 29, 2020 AB RX No No See Plans and Pricing See Plans and Pricing 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 lapatinib ditosylate

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
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 lapatinib ditosylate

Country Patent Number Title Estimated Expiration
Mexico 2007013089 COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.) See Plans and Pricing
Spain 2601503 See Plans and Pricing
Canada 2606207 PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) See Plans and Pricing
Peru 20061430 COMPOSICION FARMACEUTICA QUE COMPRENDE COMPUESTOS DE 4-QUINAZOLINAMINAS See Plans and Pricing
South Africa 200708705 Pharmaceutical composition See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lapatinib ditosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1047694 37/2008 Austria See Plans and Pricing PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 PA2008012 Lithuania See Plans and Pricing PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610
1047694 SPC/GB08/044 United Kingdom See Plans and Pricing PRODUCT NAME: LAPATINIB OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/07/440/001 20080610; UK EU/1/07/440/002 20080610
1047694 PA2008012,C1047694 Lithuania See Plans and Pricing PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REGISTRATION NO/DATE: EU/1/07/440/001, 2008-06-10 EU/1/07/440/002 20080610
1047694 CA 2008 00040 Denmark See Plans and Pricing PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
AstraZeneca
Colorcon
McKinsey
Johnson and Johnson

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.