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:	3,310
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
Scariot Foundation	N/A
GlaxoSmithKline	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.

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	8,821,927		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	6,391,874
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	8,513,262
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	7,157,466
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	6,828,320
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	6,713,485
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	6,727,256

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
Serbia	49779	BICIKLIČNA HETEROAROMATIČNA JEDINJENJA KAO INHIBITORI PROTEIN TIROZIN KINAZE (BYCICLIC HETEROAROMATIC COMPOUNDS AS PROTEIN TYROSINE KINASE INHIBITORS)
Iceland	2276
Poland	341595
Croatia	P20060387
Denmark	1047694
South Korea	20030014414
Norway	20063572

Supplementary Protection Certificates for TYKERB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1047694	SZ 37/2008	Austria		PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
1047694	SPC026/2008	Ireland		SPC026/2008: 20091118, EXPIRES: 20230609
1047694	CA 2008 00040	Denmark		PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
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	300360	Netherlands		DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
1047694	91475	Luxembourg		91475, EXPIRES: 20230610
1047694	PA2008012	Lithuania		PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610

TYKERB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tykerb (Lapatinib)

Introduction to Tykerb

Tykerb, also known as lapatinib, is a small-molecule inhibitor of the intracellular tyrosine kinase domain of EGFR and HER2. It was approved by the FDA in 2007 and by the European Medicines Agency (EMA) in 2008 for use in locally-advanced or metastatic breast cancer, particularly in patients with HER2-positive breast cancer[4][5].

Approval and Regulatory Milestones

Tykerb received its initial approval for use in combination with Xeloda (capecitabine) for the treatment of HER2-positive advanced or metastatic breast cancer. Later, in 2010, it was approved by the FDA and EMA for use in combination with letrozole for HR-positive locally advanced or metastatic breast cancer[4][5].

Market Approval and Global Reach

The positive results of the pivotal phase III trial led to marketing authorizations in 107 countries, including the USA, Europe, Australia, India, Brazil, Russia, Turkey, South Korea, and others. This widespread approval has significantly contributed to its global market presence[1].

Financial Performance

Tykerb has generated substantial revenue for its manufacturer, GlaxoSmithKline (GSK). Here are some key financial figures:

• In 2010, Tykerb generated £227 million in sales.
• In 2011, sales increased to £231 million.
• By 2012, sales reached £239 million.
• In 2013, the sales figure was £207 million.
• By 2014, the sales had slightly decreased to £171 million[1].

These figures indicate a strong financial performance for Tykerb, especially during its peak years.

Market Dynamics

Oncology Drugs Market Growth

The global oncology drugs market, within which Tykerb operates, is experiencing rapid expansion. Valued at $231.56 billion in 2024, the market is projected to reach $532.91 billion by 2031, growing at a CAGR of 12.6% during the forecast period. This growth is driven by the increasing prevalence of various cancers globally and the rising demand for innovative treatment options[3].

Targeted Therapies

Tykerb is part of the targeted therapy segment, which is expected to emerge as the largest segment by 2031. Targeted therapies, including drugs like Tykerb, have higher efficacy and reduced side effects compared to traditional cytotoxic drugs, contributing to their growing popularity and market share[3].

Competitive Landscape

The oncology drugs market is highly competitive, with key players including Hoffmann-La Roche Ltd., Genentech, Inc., Novartis AG, Gilead Sciences Inc., AstraZeneca, and others. Tykerb competes in this landscape by offering a specific treatment option for HER2-positive breast cancer, which is a significant segment within the broader oncology market[3].

Regional Market Performance

Tykerb's sales performance varies across different regions. The top eight countries for Tykerb sales include the US, France, Germany, Italy, Spain, the UK, Japan, and China. North America currently contributes the largest share to the oncology drugs market, but the Asia Pacific region is expected to witness the highest growth due to developing healthcare infrastructure and rising patient populations in countries like China and India[4][5].

Economic and Public Health Impact

Economic Benefits

The effective therapy provided by Tykerb not only generates revenue but also has broader economic benefits. Patients with better-controlled disease are often able to continue working, contributing to the workforce and reducing the economic burden of illness on families and healthcare systems[1].

Public Policy Influence

The positive results of Tykerb's clinical trials have influenced public policy, leading to widespread marketing authorizations. This regulatory approval has ensured that patients in many countries have access to this effective treatment option, reflecting a positive impact on public health policies[1].

Safety and Efficacy

Clinical Efficacy

Tykerb has been shown to be effective in treating HER2-positive breast cancer, particularly when used in combination with other therapies like capecitabine and letrozole. Clinical trials have demonstrated its efficacy in various settings, including neoadjuvant, adjuvant, and metastatic disease[4][5].

Safety Profile

While Tykerb is generally well-tolerated, it does come with some safety concerns. Notable side effects include decreased left ventricular ejection fraction (LVEF) and hepatotoxicity. Patients must undergo regular LVEF evaluations before and during treatment to ensure cardiac function remains within normal limits[2].

Sales Forecast and Market Analysis

Sales forecasts for Tykerb from 2013 to 2023 have been detailed in various market analysis reports. These forecasts cover the top eight countries and provide insights into the competitive landscape and unmet needs in the HER2-positive breast cancer market. The reports help businesses and investors understand the market dynamics and make informed decisions about product development and market strategies[4][5].

Key Takeaways

• Global Approval: Tykerb has been approved in 107 countries, ensuring a broad global reach.
• Financial Performance: Tykerb generated significant revenue for GSK, with peak sales of £239 million in 2012.
• Market Growth: The oncology drugs market is expanding rapidly, driven by the demand for targeted therapies.
• Competitive Landscape: Tykerb competes in a highly competitive market with other major pharmaceutical companies.
• Economic and Public Health Impact: Tykerb contributes to economic benefits by enabling patients to continue working and has influenced public health policies through its regulatory approvals.
• Safety and Efficacy: Tykerb is effective but requires monitoring for potential side effects like decreased LVEF and hepatotoxicity.

FAQs

Q: What is Tykerb used for?

Tykerb (lapatinib) is used for the treatment of HER2-positive locally advanced or metastatic breast cancer, often in combination with other therapies like capecitabine or letrozole.

Q: When was Tykerb approved by regulatory authorities?

Tykerb was approved by the FDA in 2007 and by the European Medicines Agency (EMA) in 2008.

Q: What are the potential side effects of Tykerb?

Tykerb can cause decreased left ventricular ejection fraction (LVEF) and hepatotoxicity, among other side effects.

Q: How has Tykerb performed financially?

Tykerb generated significant revenue for GSK, with sales peaking at £239 million in 2012.

Q: What is the projected growth of the oncology drugs market?

The global oncology drugs market is projected to grow from $231.56 billion in 2024 to $532.91 billion by 2031, at a CAGR of 12.6%.

Sources

1. HELPING INTRODUCE NEW BREAST CANCER THERAPY TO THE MARKET: Lapatinib (commercialized as Tykerb/Tyverb) - University of Edinburgh.
2. TYKERB (lapatinib) tablets: FDA Supplemental New Drug Application - accessdata.fda.gov.
3. Oncology Drugs Market to Reach USD 532.91 Billion by 2031: Coherent Market Insights.
4. Tykerb (HER2-Positive Breast Cancer) - Forecast and Market Analysis to 2023: GlobalData - PR Newswire.
5. Research and Markets: GSK's Tykerb (lapatinib) HER2-Positive Breast Cancer Treatment Report 2014 - Forecast and Market Analysis to 2023: Business Wire.