Lapatinib ditosylate - Generic Drug Details

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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, Teva Pharms Usa Inc, and Novartis, and is included in three 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-eight patent family members in twenty-six countries.

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

Summary for lapatinib ditosylate

International Patents:	28
US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	238
Clinical Trials:	67
Patent Applications:	2,565
DailyMed Link:	lapatinib ditosylate at DailyMed

Recent Clinical Trials for lapatinib ditosylate

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

Sponsor	Phase
Stanford University	Phase 2
Jonsson Comprehensive Cancer Center	Phase 1/Phase 2
Washington University School of Medicine	Phase 2

See all lapatinib ditosylate clinical trials

Pharmacology for lapatinib ditosylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lapatinib ditosylate

L01EH	Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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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
Natco Pharma Ltd	LAPATINIB DITOSYLATE	lapatinib ditosylate	TABLET;ORAL	203007-001	Sep 29, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Teva Pharms Usa Inc	LAPATINIB DITOSYLATE	lapatinib ditosylate	TABLET;ORAL	217968-001	Aug 16, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 lapatinib ditosylate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lapatinib ditosylate

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006113649		⤷ Sign Up
European Patent Office	1871347	PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)	⤷ Sign Up
Lithuania	1871347		⤷ Sign Up
Eurasian Patent Organization	200702253	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ	⤷ Sign Up
Spain	2601503		⤷ Sign Up
Argentina	054252	COMPOSICION FARMACEUTICA ORAL QUE CONTIENE SALES DE DITOSILATO DE 4-QUINAZOLINAMINA	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for lapatinib ditosylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1047694	CA 2008 00040	Denmark	⤷ Sign Up	PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
1047694	PA 2008012, C1047694	Lithuania	⤷ Sign Up	PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694	SZ 37/2008	Austria	⤷ Sign Up	PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
1047694	SPC/GB08/044	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REGISTRATION NO/DATE: EU/1/07/440/001, 2008-06-10 EU/1/07/440/002 20080610
1047694	122008000048	Germany	⤷ Sign Up	PRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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