IMATINIB MESYLATE - Generic Drug Details

What are the generic drug sources for imatinib mesylate and what is the scope of freedom to operate?

Imatinib mesylate is the generic ingredient in three branded drugs marketed by Novartis, Shorla Oncology, Amneal Pharms, Apotex, Chartwell Rx, Dr Reddys, Esjay Pharma, Eugia Pharma, Hikma, Mylan, Natco Pharma Ltd, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, and Zydus Pharms, and is included in seventeen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imatinib mesylate has six patent family members in six countries.

There are thirty-four drug master file entries for imatinib mesylate. Twenty-four suppliers are listed for this compound.

Summary for IMATINIB MESYLATE

International Patents:	6
US Patents:	1
Tradenames:	3
Applicants:	16
NDAs:	17
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	363
Patent Applications:	7,205
Drug Prices:	Drug price trends for IMATINIB MESYLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMATINIB MESYLATE
What excipients (inactive ingredients) are in IMATINIB MESYLATE?	IMATINIB MESYLATE excipients list
DailyMed Link:	IMATINIB MESYLATE at DailyMed

See drug prices for IMATINIB MESYLATE

Recent Clinical Trials for IMATINIB MESYLATE

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

Sponsor	Phase
Inhibikase Therapeutics, Inc.	Phase 1
Sarit Assouline	Phase 3
Taizhou Hospital of Zhejiang Province	Phase 2

See all IMATINIB MESYLATE clinical trials

Pharmacology for IMATINIB MESYLATE

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

Medical Subject Heading (MeSH) Categories for IMATINIB MESYLATE

Antineoplastic Agents

Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for IMATINIB MESYLATE

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IMATINIB MESYLATE

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 IMATINIB MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Natco Pharma Ltd	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	207818-001	Mar 1, 2019	AB	RX	No	No
Shilpa	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	208302-001	Jan 17, 2019	AB	RX	No	No
Dr Reddys	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	206547-002	Aug 13, 2018	AB	RX	No	No
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003	AB	RX	Yes	No
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-002	May 10, 2001		DISCN	Yes	No

Expired US Patents for IMATINIB MESYLATE

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

International Patents for IMATINIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3658190	FORMES GALÉNIQUES LIQUIDES D'IMATINIB (LIQUID DOSAGE FORMS OF IMATINIB)
Russian Federation	2020108342	ЖИДКИЕ ДОЗИРУЕМЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ИМАТИНИБА
World Intellectual Property Organization (WIPO)	2019021229
Australia	2018306149	Liquid dosage forms of imatinib
China	111278466	伊马替尼的液体剂型 (LIQUID DOSAGE FORMS OF IMATINIB)

Supplementary Protection Certificates for IMATINIB MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	2002/005	Ireland		PRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
0564409	C00564409/01	Switzerland		PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
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

Market Dynamics and Financial Trajectory for Imatinib Mesylate

Introduction to Imatinib Mesylate

Imatinib mesylate, commonly known by its brand name Gleevec, is a groundbreaking tyrosine kinase inhibitor used primarily in the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). Here, we delve into the market dynamics and financial trajectory of this pivotal drug.

Market Size and Growth Projections

The imatinib mesylate market is poised for significant growth. As of 2023, the market size was valued at USD 100 billion and is projected to reach USD 214.36 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.1% from 2024 to 2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the imatinib mesylate market:

Increasing Prevalence of CML and GIST

The rising incidence of CML and GIST is a major driver. These conditions require effective treatment options, and imatinib mesylate has become a standard therapy for these diseases[1][4].

Technological Advancements and Precision Medicine

Advances in medical technology, particularly in precision medicine and targeted therapy, have expanded the use of imatinib mesylate in oncology. This has increased its demand and market growth[1].

Government Support and Healthcare Infrastructure

Supportive government programs aimed at improving cancer care infrastructure, especially in emerging regions, are also boosting the market. Improved access to healthcare facilities and medications in these regions is a significant factor[1].

Continuous Research and Development

Ongoing research and development initiatives focused on innovative formulations and new indications for imatinib mesylate are expected to further accelerate market expansion[1].

Market Segmentation

The imatinib mesylate market is segmented based on several criteria:

Type

The market is segmented into different dosages, primarily 100mg and 400mg tablets[1].

Application

The drug is used in various settings, including hospitals and pharmacies[1].

Geographical Regions

The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America holds a significant share, while the Asia-Pacific region is expected to be the fastest-growing market[1][4].

Financial Considerations and Cost-Effectiveness

Cost-Effectiveness Analysis

Studies have shown that imatinib mesylate is a cost-effective first-line therapy for CML patients compared to other treatments like interferon-alpha plus low-dose cytarabine (IFN+LDAC). Despite higher upfront costs, imatinib mesylate offers significant survival benefits, with an estimated mean survival of 15.30 years compared to 9.07 years with IFN+LDAC[2].

Pricing Dynamics

The price of imatinib mesylate has been a subject of controversy. Initially launched at $32,000 per year, the price escalated to over $100,000 per year by 2012, largely due to market exclusivity and profit maximization. The introduction of generic versions in 2017 did not significantly reduce prices due to various market maneuvers by pharmaceutical companies[5].

Generic Impact

The availability of generic imatinib mesylate has had a mixed impact. While the wholesale acquisition cost of generics is significantly lower (e.g., $6,900 per year for Apotex), the average wholesale price charged to patients or their insurance companies remains high (e.g., $131,200 per year). Initiatives like Mark Cuban's CostPlus Drugs aim to address this disparity by offering generic imatinib at more affordable prices (e.g., $564 per year)[5].

Competitive Landscape

The imatinib mesylate market is competitive, with several major players:

Key Players

Companies such as Novartis AG, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., Mylan N.V., and Dr. Reddy's Laboratories Ltd. are dominant in the market. These companies are involved in continuous research and development, product benchmarking, and strategic market positioning[1][4].

Market Dynamics Analysis

A Porter’s Five Forces analysis reveals the competitive dynamics, including buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition. The market is characterized by strong competition among existing players and moderate barriers to entry for new entrants[1].

Regional Market Analysis

North America

North America holds the largest market share due to high incidences of cancer and a well-established healthcare infrastructure. The region is expected to continue its dominance due to increased adoption of novel agents and growing healthcare expenditure[3][4].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market, driven by increasing healthcare infrastructure and rising awareness of targeted therapies[1][4].

Challenges and Opportunities

Challenges

• High Pricing and Affordability: Despite the availability of generics, the high pricing of imatinib mesylate remains a challenge, affecting patient affordability and access[5].
• Patent Expiries: The patent expiries of branded TKIs could impact market dynamics, although this also opens opportunities for generic formulations[3].

Opportunities

• Expanding Indications: Continuous research on new indications for imatinib mesylate can expand its market potential[1].
• Emerging Markets: Growing healthcare infrastructure in emerging regions presents significant opportunities for market growth[1].

Key Takeaways

• The imatinib mesylate market is projected to grow significantly, driven by increasing prevalence of CML and GIST, technological advancements, and supportive government programs.
• The market is segmented by type, application, and geographical regions, with North America holding the largest share and the Asia-Pacific region being the fastest-growing.
• Despite high upfront costs, imatinib mesylate is cost-effective in the long term, offering significant survival benefits.
• The introduction of generics has not significantly reduced prices due to market dynamics, but initiatives like CostPlus Drugs aim to make the drug more affordable.
• The competitive landscape is dominated by major pharmaceutical companies, with ongoing research and development driving market growth.

FAQs

What is the current market size of the imatinib mesylate market?

The imatinib mesylate market was valued at USD 100 billion in 2023[1].

What is the projected growth rate of the imatinib mesylate market?

The market is expected to grow at a CAGR of 5.1% from 2024 to 2031[1].

Which region holds the largest market share for imatinib mesylate?

North America holds the largest market share for imatinib mesylate[3][4].

What are the key drivers of the imatinib mesylate market growth?

Key drivers include the increasing prevalence of CML and GIST, technological advancements, and supportive government programs[1].

How has the introduction of generic imatinib mesylate affected pricing?

The introduction of generics has not significantly reduced prices due to various market maneuvers, but initiatives like CostPlus Drugs aim to make the drug more affordable[5].

Who are the major players in the imatinib mesylate market?

Major players include Novartis AG, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., Mylan N.V., and Dr. Reddy's Laboratories Ltd.[1][4].

Sources

1. Market Research Intellect: Global Imatinib Mesylate Drugs Market Size and Forecast.
2. PubMed: Cost-effectiveness of imatinib versus interferon-alpha plus low-dose cytarabine.
3. GlobalData: Chronic Myeloid Leukemia (CML): Global Drug Forecast and Market Analysis.
4. Mordor Intelligence: Imatinib Drug Market - Size, Share & Industry Analysis.
5. ASCO Post: Influence of the 'Mark Cuban Effect' on Cancer Drug Prices in the United States: Focus on CML.