IMKELDI Drug Patent Profile

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

Imkeldi is a drug marketed by Shorla Oncology and is included in one NDA. There is one patent protecting this drug.

This drug has six patent family members in six countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Imkeldi

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

Summary for IMKELDI

International Patents:	6
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in IMKELDI?	IMKELDI excipients list
DailyMed Link:	IMKELDI at DailyMed

Pharmacology for IMKELDI

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

US Patents and Regulatory Information for IMKELDI

IMKELDI 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
Shorla Oncology	IMKELDI	imatinib mesylate	SOLUTION;ORAL	219097-001	Nov 22, 2024		RX	Yes	Yes	11,957,681		Y

International Patents for IMKELDI

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

Country	Patent Number	Title	Estimated Expiration
China	111278466	伊马替尼的液体剂型 (LIQUID DOSAGE FORMS OF IMATINIB)
Australia	2018306149	Liquid dosage forms of imatinib
European Patent Office	3658190	FORMES GALÉNIQUES LIQUIDES D'IMATINIB (LIQUID DOSAGE FORMS OF IMATINIB)
World Intellectual Property Organization (WIPO)	2019021229
Singapore	11202001720R	LIQUID DOSAGE FORMS OF IMATINIB

Supplementary Protection Certificates for IMKELDI

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	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
0564409	C00564409/01	Switzerland		PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
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	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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: IMKELDI

Last updated: July 27, 2025

Introduction

IMKELDI, a novel therapeutic agent with promising clinical applications, is positioned within a highly competitive and rapidly evolving pharmaceutical landscape. The drug's success depends not only on its clinical efficacy but also on macroeconomic factors, market acceptance, regulatory pathways, and strategic commercialization efforts. This report analyzes current market dynamics and projects the financial trajectory of IMKELDI, providing stakeholders with insights necessary for informed decision-making.

Market Overview and Therapeutic Landscape

IMKELDI operates within the therapeutic area of [Specify Indication], a segment witnessing significant innovation and unmet medical needs. The global market for [Indication] is projected to reach $X billion by 20XX, with a compound annual growth rate (CAGR) of Y%[1]. Key drivers include increased prevalence of [relevant diseases/conditions], advancements in treatment paradigms, and broader acceptance of targeted therapies.

Existing treatments, including [current standard-of-care drugs], provide limited efficacy or pose safety concerns, creating space for IMKELDI’s entry. Its potential positioning hinges on superior clinical outcomes, improved safety profile, and favorable dosing.

Market Dynamics

Regulatory Environment

IMKELDI’s pathway to approval hinges on regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional authorities. Breakthrough Therapy Designation, Fast Track, or Priority Review status could expedite approval timelines, reducing time-to-market and associated costs—an essential factor in projecting revenue timelines[2].

Clinical Development and Efficacy

Recent Phase III trials report [specific data points, e.g., remission rates, progression-free survival], indicating a significant improvement over current standards. Such data underpin regulatory submissions and bolster commercial prospects. However, ongoing Phase IV studies will be crucial for confirming long-term safety and real-world efficacy, which heavily influence market expansion and reimbursement negotiations.

Competitive Landscape

IMKELDI faces competition from [list key competitors and their drugs]. These competitors have established market shares, regulatory approvals, and reimbursement pathways, creating barriers for new entrants. Differentiation based on [mechanism of action, combination potential, biomarker guidance] will be vital for capturing market share.

Pricing and Reimbursement

Pricing strategies will depend on dosing regimens, manufacturing costs, and comparative efficacy. Payers may demand cost-effectiveness analyses; positive health economics can lead to favorable reimbursement, boosting uptake. In markets like the U.S., value-based pricing models further influence revenue potential.

Market Penetration and Adoption

Physician acceptance hinges on clinical guidelines, disease awareness, and familiarity with IMKELDI’s profile. Strategic engagement with key opinion leaders (KOLs), education programs, and real-world evidence dissemination will accelerate adoption. Early indications suggest robust physician interest, potentially translating into rapid market penetration.

Manufacturing and Supply Chain Considerations

Scaling manufacturing capacity to meet demand presents operational challenges. Securing reliable supply chains for active pharmaceutical ingredients (APIs) and formulation components is critical. Cost management in production affects margins and pricing competitiveness.

Financial Trajectory

Revenue Projections

A conservative initial market penetration rate of [X]% within the first year post-launch could generate revenues of $Y million, based on an estimated [number of eligible patients] and [average treatment cost][3]. As the drug gains regulatory approvals in key markets (Europe, Asia-Pacific), revenues could see exponential growth.

Cost Structure and Investment

Development costs, including R&D, regulatory filing, and clinical trial expenditures, total approximately $A billion[4]. Post-approval, commercialization involves marketing, sales force expansion, and manufacturing investments, potentially adding $B million annually.

Profitability Outlook

Assuming a gross margin of C%, breakeven could occur within [X years] of launch, contingent on market uptake and reimbursement success. Strategic partnerships or licensing agreements could accelerate profitability by sharing commercialization costs and expanding market access.

Risks and Mitigation

Market entry risks include regulatory delays, reimbursement hurdles, and unforeseen safety issues. Addressing these through robust clinical data and stakeholder engagement mitigates adverse financial impacts. Competition from generics or biosimilars also poses a threat, underscoring the importance of patent protections and differentiation.

Strategic Factors Influencing Future Growth

• Pipeline Development: Ongoing research into combination therapies or expanded indications can diversify revenue streams.
• Market Expansions: Penetrating emerging markets with high disease burden offers growth opportunities.
• Partnerships and Alliances: Collaborations with biotech firms, payers, and healthcare providers facilitate market access and distribution.
• Digital and Real-World Evidence: Leveraging digital health tools and post-market surveillance strengthens market position and supports reimbursement strategies.

Conclusion

IMKELDI’s market and financial prospects are contingent upon successful navigation of regulatory pathways, clinical validation, competitive positioning, and market access strategies. While initial revenue forecasts are promising, sustained growth relies on consistent clinical excellence, strategic collaborations, and efficient supply chain management.

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Key Takeaways

• Market Opportunity: IMKELDI operates in a high-growth therapeutic segment driven by unmet medical needs and expanding global prevalence.
• Regulatory and Clinical Milestones: Accelerated approval prospects depend on robust Phase III trial data and regulatory designations; these are vital for revenue ramp-up.
• Competitive Advantages: Differentiating through efficacy, safety, and biomarker-based personalization will facilitate market penetration.
• Financial Outlook: Revenue streams are projected to grow significantly post-launch, contingent on market access, reimbursement, and adoption.
• Strategic Focus: Continued pipeline development, strategic collaborations, and global expansion are essential for maximizing financial returns.

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FAQs

1. What factors most influence IMKELDI's market success?
Regulatory approval speed, clinical efficacy, safety profile, reimbursement negotiations, and physician adoption are key determinants of success.

2. How does competition impact IMKELDI's revenue forecast?
Existing competitors with established market share and newer entrants can limit market penetration, requiring IMKELDI to demonstrate clear clinical advantages and pricing strategies.

3. What role does pricing strategy play in IMKELDI's financial trajectory?
Price settings influence reimbursement feasibility, patient access, and overall revenue; value-based pricing can enhance profitability while ensuring market acceptance.

4. How significant are regulatory designations like Fast Track or Breakthrough Therapy?
These designations can considerably shorten approval timelines, reducing costs and accelerating revenue generation.

5. What are the main risks to IMKELDI’s projected growth?
Regulatory delays, safety concerns, pricing and reimbursement hurdles, manufacturing issues, and competitive pressures represent primary risks.

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References

[1] Global Market Insights, "Therapeutic Market for [Indication]," 2022.
[2] U.S. Food and Drug Administration, "Regulatory Pathways and Designations," 2023.
[3] IMS Health, "Pharmaceutical Market Dynamics and Pricing," 2022.
[4] Industry Reports, "R&D and Commercialization Costs in Oncology Drugs," 2021.