tykerb Drug Patent Profile

✉ Email this page to a colleague

When do Tykerb patents expire, 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.

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for tykerb?
What are the global sales for tykerb?
What is Average Wholesale Price for tykerb?

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:	3,411
Drug Prices:	Drug price information for tykerb
What excipients (inactive ingredients) are in tykerb?	tykerb excipients list
DailyMed Link:	tykerb at DailyMed

Drug patent expirations by year for tykerb

Recent Clinical Trials for tykerb

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

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

See all tykerb clinical trials

Pharmacology for tykerb

Drug Class	Kinase 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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 tykerb

Subscribe to access the full database, or Sign Up
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
>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
Patent: COMPOSICION FARMACEUTICA ORAL QUE CONTIENE SALES DE DITOSILATO DE 4-QUINAZOLINAMINA
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 06236423
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0609962
Patent: composição farmacêutica oral, e, método para tratar um distúrbio em um mamìfero
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 06207
Patent: PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up

China

Patent: 1203211
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0161429
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 18179
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 71347
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 0702253
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 71347
Patent: PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 30982
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 02302
Estimated Expiration: ⤷ Sign Up

Patent: 08536931
Estimated Expiration: ⤷ Sign Up

Lithuania

Patent: 71347
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 07013089
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 404
Patent: PREPARATION PHARMACEUTIQUE
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 2223
Patent: Pharmaceutical composition comprising lapatinib or N-{3-chloro-4-[(3-fluorobenzyl)oxy]phenyl}-6-[5-({[2-(methanesulphonyl)ethyl]amino}methyl)-2-furyl]4-quinazolinamine
Estimated Expiration: ⤷ Sign Up

Norway

Patent: 075111
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 061430
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE COMPUESTOS DE 4-QUINAZOLINAMINAS
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 71347
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 71347
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 71347
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 0708705
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1356748
Estimated Expiration: ⤷ Sign Up

Patent: 080005557
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 01503
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 0716204
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up

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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
European Patent Office	1294715	COMPOSES DITOSYLATES DE QUINAZOLINE (QUINAZOLINE DITOSYLATE SALT COMPOUNDS)	⤷ Sign Up
South Korea	20080005557	PHARMACEUTICAL COMPOSITION	⤷ Sign Up
Eurasian Patent Organization	200000637		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tykerb

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1047694	SZ 37/2008	Austria	⤷ Sign Up	PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
1047694	300360	Netherlands	⤷ Sign Up	DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
1047694	CA 2008 00040	Denmark	⤷ Sign Up	PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

AI Research Assistant

Questions you can ask:

Summary for tykerb

Recent Clinical Trials for tykerb

Pharmacology for tykerb

Paragraph IV (Patent) Challenges for TYKERB

Patents protecting tykerb

When does loss-of-exclusivity occur for tykerb?

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