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Last Updated: December 24, 2024

tykerb Drug Patent Profile


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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 29th, 2020.

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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
Drug patent expirations by year for tykerb
Drug Prices for tykerb

See drug prices for tykerb

Recent Clinical Trials for tykerb

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

SponsorPhase
Aslan PharmaceuticalsPhase 2
AbbVieN/A
Scariot FoundationN/A

See all tykerb clinical trials

Pharmacology for tykerb
Drug ClassKinase Inhibitor
Mechanism of ActionProtein 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 ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
>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

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

Australia

Patent: 06236423
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Subscribe

Brazil

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

Canada

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

China

Patent: 1203211
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0161429
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 18179
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 71347
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 0702253
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Subscribe

European Patent Office

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

Hungary

Patent: 30982
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 02302
Estimated Expiration: ⤷  Subscribe

Patent: 08536931
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 71347
Estimated Expiration: ⤷  Subscribe

Mexico

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

Morocco

Patent: 404
Patent: PREPARATION PHARMACEUTIQUE
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

Norway

Patent: 075111
Estimated Expiration: ⤷  Subscribe

Peru

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

Poland

Patent: 71347
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 71347
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 71347
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 0708705
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1356748
Estimated Expiration: ⤷  Subscribe

Patent: 080005557
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 01503
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 0716204
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Subscribe

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) ⤷  Subscribe
Iceland 2276 ⤷  Subscribe
Poland 341595 ⤷  Subscribe
Croatia P20060387 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tykerb

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1047694 SZ 37/2008 Austria ⤷  Subscribe PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
1047694 SPC026/2008 Ireland ⤷  Subscribe SPC026/2008: 20091118, EXPIRES: 20230609
1047694 CA 2008 00040 Denmark ⤷  Subscribe PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
1047694 SPC/GB08/044 United Kingdom ⤷  Subscribe PRODUCT NAME: LAPATINIB OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/07/440/001 20080610; UK EU/1/07/440/002 20080610
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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