TYKERB Drug Patent Profile

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-eight patent family members in twenty-six 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 29^th, 2020.

Summary for TYKERB

International Patents:	28
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	96
Patent Applications:	4,258
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TYKERB
What excipients (inactive ingredients) are in TYKERB?	TYKERB excipients list
DailyMed Link:	TYKERB at DailyMed

See drug prices for TYKERB

Recent Clinical Trials for TYKERB

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

Sponsor	Phase
Aslan Pharmaceuticals	Phase 2
GlaxoSmithKline	N/A
University of Alabama at Birmingham	N/A

See all TYKERB clinical trials

Pharmacology for TYKERB

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TYKERB

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 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

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			Y	Y

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
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Japan

Lithuania

Mexico

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

Taiwan

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
Turkey	200002015
Canada	2413134	COMPOSES DITOSYLATES DE QUINAZOLINE (QUINAZOLINE DITOSYLATE SALT COMPOUNDS)
Estonia	200000411
Japan	2004502687

Supplementary Protection Certificates for TYKERB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1047694	PA 2008012, C1047694	Lithuania		PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694	122008000048	Germany		PRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694	SPC/GB08/044	United Kingdom		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	SPC026/2008	Ireland		SPC026/2008: 20091118, EXPIRES: 20230609