GLEEVEC Drug Patent Profile

When do Gleevec patents expire, and when can generic versions of Gleevec launch?

Gleevec is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in GLEEVEC is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gleevec

A generic version of GLEEVEC was approved as imatinib mesylate by SUN PHARM on December 3^rd, 2015.

Summary for GLEEVEC

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	235
Patent Applications:	3,903
Drug Prices:	Drug price information for GLEEVEC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLEEVEC
What excipients (inactive ingredients) are in GLEEVEC?	GLEEVEC excipients list
DailyMed Link:	GLEEVEC at DailyMed

See drug prices for GLEEVEC

Recent Clinical Trials for GLEEVEC

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

Sponsor	Phase
Reema A. Patel	Phase 2
H. Jean Khoury Cure CML Consortium	Phase 2
Research Institute for Gastroenterology and Liver Diseases (RIGLD)	Phase 1/Phase 2

See all GLEEVEC clinical trials

Pharmacology for GLEEVEC

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

Paragraph IV (Patent) Challenges for GLEEVEC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLEEVEC	Tablets	imatinib mesylate	100 mg and 400 mg	021588	1	2007-03-12

US Patents and Regulatory Information for GLEEVEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-001	May 10, 2001		DISCN	Yes	No
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003	AB	RX	Yes	Yes
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-002	May 10, 2001		DISCN	Yes	No
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003	AB	RX	Yes	No

Expired US Patents for GLEEVEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-002	May 10, 2001
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-001	May 10, 2001

International Patents for GLEEVEC

See the table below for patents covering GLEEVEC around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	10299016
Norway	324948
Slovenia	0998473
European Patent Office	0998473	MODIFICATION DE LA FORME CRISTALLINE D'UN DERIVE N-PHENYL-2-PYRIMIDINEAMINE, PROCEDE DE PREPARATION ET D'UTILISATION DE CE DERNIER (CRYSTAL MODIFICATION OF A N-PHENYL-2-PYRIMIDINEAMINE DERIVATIVE, PROCESSES FOR ITS MANUFACTURE AND ITS USE)
Colombia	4940418	MODIFICACION DE CRISTAL DE UN DERIVADO DE N-FENIL-2- PIRIMIDINAMINA, PROCESOS PARA SU FABRICACION Y SU USO
Russian Federation	2301066	ЛЕЧЕНИЕ ЖЕЛУДОЧНО-КИШЕЧНЫХ СТРОМАЛЬНЫХ ОПУХОЛЕЙ (METHOD FOR TREATING GASTROINTESTINAL STROMAL TUMOR CASES)

Supplementary Protection Certificates for GLEEVEC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0564409	SPC/GB02/016	United Kingdom		PRODUCT NAME: IMATINIB (INN I.E. NON INTELLECTUAL PROPRIETARY NAME) OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; REGISTERED: CH IKS-NR: 55807 20010621; UK SG(2001) D/292083 20011108
0564409	SPC005/2002	Ireland		SPC005/2002: 20051123, EXPIRES: 20160620
0564409	CA 2002 00005	Denmark
0564409	02C0012	France		PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
0564409	90908	Luxembourg
0564409	C300086	Netherlands		PRODUCT NAME: IMATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESILAAT; NATL. REGISTRATION NO/DATE: EU/1/01/198/001 - 006 20011107; FIRST REGISTRATION: CH IKS 55807 20010621

GLEEVEC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gleevec

Introduction

Gleevec, also known as imatinib, is a groundbreaking drug developed by Novartis for the treatment of certain types of cancer, most notably chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GISTs). The market dynamics and financial trajectory of Gleevec are influenced by several key factors, including the rising incidence of cancer, advancements in cancer research, healthcare expenditure, generic competition, and pricing strategies.

Increasing Cancer Incidence

The growing incidence of cancer, particularly CML, is a significant driver for the Gleevec market. As the global population ages and lifestyle factors contribute to higher cancer rates, the demand for effective treatments like Gleevec increases. This trend is expected to continue, with the Gleevec market projected to grow from $344 million in 2023 to $644.7 million by 2031, at a CAGR of 8.29%[1].

Advancements in Cancer Research and Technology

Continuous innovations in targeted therapies and precision medicine have enhanced the treatment landscape for CML. Research into biomarkers and genetic mutations has improved the understanding and treatment of CML, solidifying Gleevec's role in clinical guidelines. Ongoing studies and clinical trials exploring new indications further bolster Gleevec’s relevance, contributing to a robust market ecosystem[1].

Increased Healthcare Expenditure

The global increase in healthcare expenditure has significantly contributed to the growth of the Gleevec market. Governments and private sectors are investing more in innovative cancer treatments, particularly in developed nations where healthcare policies focus on improving patient outcomes. This trend ensures financial support for drugs like Gleevec, enabling healthcare providers to prescribe advanced therapeutic options that improve survival rates and quality of life[1].

Growing Awareness and Screening Programs

Increased awareness and early diagnosis of diseases, along with ongoing clinical trials and approvals for new indications, sustain the growth of the Gleevec market. Early detection and screening programs have become more prevalent, leading to a higher number of patients being diagnosed and treated with Gleevec[1].

High Cost of Medication

Despite its efficacy, the high cost of Gleevec is a significant restraint on its market growth. With a yearly cost often exceeding $146,000, affordability becomes a barrier for many patients, especially in low- and middle-income countries. High out-of-pocket expenses can deter patients from initiating or continuing treatment, reducing market penetration[3][4].

Generic Competition

The advent of generic imatinib in the U.S. market has had a profound impact on Gleevec’s financial trajectory. Generic competition, which began in 2016, has led to a decline in Novartis’ sales of the branded drug. Despite this, Novartis has managed to retain a significant portion of its market share through strategic pricing and patient assistance programs[2][3].

Impact on Novartis' Financials

The loss of exclusivity and the entry of generic imatinib into the U.S. market resulted in a decline in Novartis’ core operating income. In the second quarter of 2016, Novartis reported a 7% decrease in core operating income, primarily due to the impact of generic competition on Gleevec sales. However, growth products such as Gilenya and Cosentyx helped offset some of this decline[2].

Pricing Strategies and Revenue

Novartis has employed aggressive pricing strategies to maximize revenue from Gleevec. Since its launch, the price of Gleevec has been increased 22 times, with a compound annual growth rate of 13% as of 2016. These price increases have contributed significantly to Novartis’ revenue, with U.S. net revenue for Gleevec increasing from $1 billion in 2009 to over $2.5 billion in 2015[4].

Profit-Driven Pricing

Internal documents reveal that Novartis aimed to raise prices to meet revenue goals while minimizing public backlash. The company increased prices steadily, especially as the drug approached the end of its primary patent exclusivity. For instance, the price of Gleevec increased by 20% in 2013 alone and by 32% from January 2014 to July 2015[4].

Patient Assistance Programs

To mitigate the impact of generic competition, Novartis implemented patient assistance programs, including co-payment plans. These programs helped reduce patient price sensitivity and encouraged patients to stay on the branded drug even after generic versions became available. This strategy was crucial in retaining a significant market share for Gleevec[4].

Regional Market Dynamics

The Gleevec market varies significantly across different regions:

North America

North America, led by the United States, has been the largest market for Gleevec due to its advanced healthcare infrastructure, higher prevalence of CML, and robust healthcare policies. The region benefits from significant investment in research and development and strong insurance coverage, facilitating patient access to the drug[1].

Europe

In Europe, the market is characterized by well-established healthcare systems and emerging markets. The European Medicines Agency (EMA) has played a crucial role in providing regulatory approvals, facilitating access to Gleevec. Countries like Germany, France, and the UK are key contributors due to their emphasis on precision medicine and targeted therapies[1].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth in the Gleevec market, driven by increasing incidences of CML, improving healthcare access, and rising patient awareness. However, the region faces challenges such as economic disparities and varying regulatory environments[1].

Middle East and Africa, Latin America

These regions are emerging markets with potential for growth as healthcare infrastructure develops and more focus is placed on cancer treatment. Despite the challenges, these regions offer opportunities for market expansion[1].

Adverse Effects and Resistance

While Gleevec is highly effective, it also faces challenges related to adverse effects and resistance. Patients may experience side effects, and over time, some may develop resistance to the drug. These factors can impact the long-term use and market growth of Gleevec[1].

Key Takeaways

• The Gleevec market is driven by the increasing incidence of cancer, advancements in cancer research, and increased healthcare expenditure.
• High medication costs and generic competition are significant restraints on market growth.
• Novartis has employed aggressive pricing strategies and patient assistance programs to maximize revenue and retain market share.
• Regional dynamics, including healthcare infrastructure and regulatory environments, significantly influence the market trajectory.
• Despite challenges, Gleevec remains a critical component of cancer treatment regimens worldwide.

FAQs

What is the projected growth of the Gleevec market?

The Gleevec market is projected to grow from $344 million in 2023 to $644.7 million by 2031, at a CAGR of 8.29%[1].

How has generic competition affected Gleevec sales?

The entry of generic imatinib into the U.S. market in 2016 led to a decline in Novartis’ sales of the branded drug, although the company has retained a significant market share through strategic pricing and patient assistance programs[2][3].

Why is the cost of Gleevec so high?

The cost of Gleevec is high due to Novartis’ aggressive pricing strategies, which have included numerous price increases since the drug's launch. This has resulted in a yearly cost exceeding $146,000[3][4].

How does regional variation impact the Gleevec market?

Regional dynamics, including healthcare infrastructure, regulatory environments, and patient awareness, significantly influence the market trajectory. North America is the largest market, while the Asia-Pacific region is experiencing rapid growth[1].

What strategies has Novartis used to mitigate generic competition?

Novartis has used patient assistance programs, including co-payment plans, and strategic pricing to encourage patients to stay on the branded drug even after generic versions became available[4].

Sources

1. Verified Market Research: Gleevec Market Size, Scope, Growth, Trends and Forecast.
2. Novartis: Novartis delivered solid Q2 despite full quarter of US Gleevec generic impact.
3. The ASCO Post: The Arrival of Generic Imatinib Into the U.S. Market.
4. House Committee on Oversight and Reform: Drug Pricing Investigation.