ICLUSIG Drug Patent Profile

When do Iclusig patents expire, and what generic alternatives are available?

Iclusig is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eight patent family members in twenty-four countries.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Iclusig

Iclusig was eligible for patent challenges on December 14, 2016.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (ponatinib hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for ICLUSIG

International Patents:	108
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	26
Patent Applications:	1,232
Drug Prices:	Drug price information for ICLUSIG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ICLUSIG
What excipients (inactive ingredients) are in ICLUSIG?	ICLUSIG excipients list
DailyMed Link:	ICLUSIG at DailyMed

See drug prices for ICLUSIG

Recent Clinical Trials for ICLUSIG

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

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE2
University of Chicago	Phase 2
CZECRIN - Czech Clinical Research Infrastructure Network	Phase 2

See all ICLUSIG clinical trials

Pharmacology for ICLUSIG

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for ICLUSIG

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ICLUSIG	Tablets	ponatinib hydrochloride	10 mg and 30 mg	203469	1	2022-12-12
ICLUSIG	Tablets	ponatinib hydrochloride	15 mg and 45 mg	203469	1	2021-03-31

US Patents and Regulatory Information for ICLUSIG

ICLUSIG is protected by seventeen US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No	9,493,470		Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No	11,192,897			Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes	9,493,470		Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No	8,114,874		Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No	11,192,895
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No	9,029,533
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes	9,029,533

International Patents for ICLUSIG

When does loss-of-exclusivity occur for ICLUSIG?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Chile

China

Hong Kong

Japan

Mexico

New Zealand

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 ICLUSIG around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2021002254	FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-N-(4-[(4-METILPIPERAZIN-1-IL) METIL]-3-(TRIFLUOROMETIL)FENIL) BENZAMIDA Y SU SAL DE MONOCLORHIDRATO. (CRYSTALLINE FORMS OF 3-(IMIDAZO[1,2-B] PYRIDAZIN-3-YLETHYNYL)-4-M ETHYL-N-(4-[(4-METHYLPIPERAZIN-1-YL) METHYL]-3-(TRIFLUOROMETHYL)P HENYL)BENZAMIDE AND ITS MONO HYDROCHLORIDE SALT.)
Japan	2023179498	３－（イミダゾ［１，２－ｂ］ピリダジン－３－イルエチニル）－４－メチル－Ｎ－｛４－［（４－メチルピペラジン－１－イル）メチル］－３－（トリフルオロメチル）フェニル｝ベンズアミドおよびその一塩酸塩の結晶形 (CRYSTALLINE FORMS OF 3-(IMIDAZO[1,2-b]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-{4-[(4-METHYLPIPERAZIN-1-YL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL}BENZAMIDE AND ITS MONOHYDROCHLORIDE SALTS)
Japan	2018168191	３−（イミダゾ［１，２−ｂ］ピリダジン−３−イルエチニル）−４−メチル−Ｎ−｛４−［（４−メチルピペラジン−１−イル）メチル］−３−（トリフルオロメチル）フェニル｝ベンズアミドおよびその一塩酸塩の結晶形 (CRYSTALLINE FORMS OF 3-(IMIDAZO[1,2-b]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-{4-[(4-METHYLPIPERAZIN-1-YL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL}BENZAMIDE AND ITS MONOHYDROCHLORIDE SALTS)
Australia	2025204582
France	13C0069
Mexico	2008014289	COMPUESTOS HETEROARILICOS ACETILENICOS. (ACETYLENIC HETEROARYL COMPOUNDS.)
Eurasian Patent Organization	200870515

Supplementary Protection Certificates for ICLUSIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1973545	122013000152	Germany		PRODUCT NAME: PONATINIB "BENZAMID, 3-(2-IMIDAZO(1,2-B)PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-(4-((4-METHYL-1-PIPERAZINYL)METHYL)-3-(TRIFLUORMETHYL)PHENYL)"; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545	72/2013	Austria		PRODUCT NAME: PONATINIB; REGISTRATION NO/DATE: EU/1/13/839 20130701
1973545	2013/059	Ireland		PRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545	1390059-2	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20261223 - 20280702
1973545	C300631	Netherlands		PRODUCT NAME: PONATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545	SPC/GB13/077	United Kingdom		PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, SOLVATE OR HYDRATE THEREOF; REGISTERED: UK EU/1/13/839/001 20130703; UK EU/1/13/839/002 20130703; UK EU/1/13/839/003 20130703; UK EU/1/13/839/004 20130703
1973545	2013C/073	Belgium		PRODUCT NAME: PONATINIB; AUTHORISATION NUMBER AND DATE: EU/1/13/839/001 20130703

Market Dynamics and Financial Trajectory for ICLUSIG®

Last updated: July 27, 2025

Introduction

ICLUSIG® (pemigatinib) is a targeted kinase inhibitor developed by Takeda Pharmaceuticals, approved for the treatment of specific cases of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Since its initial approval by the FDA in late 2016, ICLUSIG’s market dynamics have been shaped by a combination of clinical efficacy, regulatory developments, competitive landscape, and evolving treatment paradigms. This article provides a comprehensive analysis of ICLUSIG's market trajectory, exploring current dynamics, future growth prospects, and strategic considerations essential for stakeholders.

Market Overview

Indications and Clinical Profile

ICLUSIG targets patients with refractory or resistant CML and Ph+ ALL, notably those harboring the T315I mutation—an especially resistant form of leukemia. Its unique mechanism offers a critical treatment option when other tyrosine kinase inhibitors (TKIs) fail, positioning ICLUSIG within a niche but vital segment of the myeloid leukemia market.

Market Size and Penetration

Globally, CML affects approximately 150,000–200,000 patients, with a significant proportion diagnosed in advanced stages or possessing resistant mutations such as T315I [1]. The Ph+ ALL subset comprises a smaller but clinically significant population. The total addressable patient pool for ICLUSIG remains niche but lucrative given the high unmet need in resistant cases.

Regulatory Landscape

After initial approval, ICLUSIG’s label faced scrutiny due to adverse events—including vascular occlusive events—prompting a Risk Evaluation and Mitigation Strategy (REMS) program. The FDA’s REMS has impacted prescribing patterns but has also reinforced the drug’s role in resistant cases where alternatives are limited.

Market Dynamics

Competitive Landscape

ICLUSIG’s primary competitors include other TKIs like imatinib, dasatinib, nilotinib, bosutinib, and newer agents such as asciminib. While these drugs serve broader CML indications, their efficacy diminishes in T315I mutation cases, offering ICLUSIG a unique value proposition. Additionally, emerging therapies with novel mechanisms—like allosteric inhibitors—are expanding the therapeutic landscape, potentially affecting ICLUSIG’s market share.

Prescribing Trends and Market Penetration

Prescribing behavior is influenced by safety considerations, mutation status, and clinician familiarity. The REMS program has fostered cautious use, but recent data suggest stabilization in prescribing volumes as physicians weigh risks versus benefits. The drug’s penetration remains limited primarily to resistant patient subsets, with ongoing education and real-world evidence supporting expanded use.

Pricing and Reimbursement

ICLUSIG is positioned at a premium pricing tier reflecting its targeted indication and clinical need. Reimbursement policies significantly influence uptake, particularly in markets with strict cost-containment measures like Europe and the U.S. healthcare systems. The drug’s high cost and safety profile continue to influence payer decisions.

Pharmacovigilance and Market Challenges

Adverse events, especially vascular occlusion, necessitate vigilant pharmacovigilance. These safety signals can impact patient selection and prescribing practices, potentially limiting market growth. Continued reporting and real-world safety data are critical for maintaining clinician confidence.

Financial Trajectory and Future Outlook

Revenue Projections

Takeda’s financial disclosures suggest ICLUSIG generates modest but stable revenues in the mid-single-digit millions annually in the U.S., with negligible contributions from other markets. Growth projections hinge on expanding indications, optimizing prescriber confidence, and potential label modifications.

Growth Strategies

• Label Expansion: Further clinical trials targeting earlier lines of therapy or broader mutation profiles could unlock new revenue streams.
• Geographic Expansion: Increasing access in emerging markets remains a priority, contingent upon regulatory approvals and reimbursement frameworks.
• Combination Therapies: Investigating ICLUSIG in combination with other agents might enhance efficacy, expanding its role in treatment protocols.
• Real-World Evidence (RWE): Leveraging RWE can demonstrate safety and efficacy, aiding in acceptance for broader indications.

Impact of Emerging Therapies

Novel agents—such as asciminib, a first-in-class allosteric TKI—pose competitive threats, particularly in resistant CML. Their increasing approval and adoption could constrain ICLUSIG’s growth unless it demonstrates differentiated clinical benefits or secures label updates.

Regulatory and Market Risks

Regulatory actions addressing safety concerns, or changes in reimbursement policies, could adversely impact sales. Conversely, positive safety profiles and successful label updates can enhance market penetration.

Strategic Considerations

• Patient Stratification: Focus on resistant mutation profiles to optimize prescribing.
• Clinical Evidence: Prioritize clinical trials examining ICLUSIG in combination or earlier in treatment lines.
• Stakeholder Engagement: Collaborate with clinicians and payers to highlight ICLUSIG’s niche benefits.
• Safety Profile Management: Emphasize pharmacovigilance to maintain confidence among prescribers and patients.

Conclusion

ICLUSIG’s market trajectory is characterized by stable but limited growth, predominantly driven by its role in resistant leukemia cases. The drug’s future hinges on addressing safety concerns, expanding clinical indications, and adapting to competitive innovations. Strategic positioning, rigorous safety management, and continued clinical evidence generation will determine its long-term financial viability and market impact.

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Key Takeaways

• ICLUSIG occupies a niche market focused on resistant CML and Ph+ ALL, with limited but strategically important growth potential.
• Clinical safety concerns and regulatory measures, such as REMS, influence prescribing behavior and market penetration.
• Competition from emerging therapies like asciminib poses significant challenges, emphasizing the need for differentiation and clinical validation.
• Geographic expansion and label extensions represent viable pathways for revenue growth.
• Ongoing pharmacovigilance and real-world data are critical for maintaining market confidence and optimizing prescribing practices.

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FAQs

1. What are the main drivers of ICLUSIG’s market growth?
Market growth is primarily driven by expanding its use in resistant CML cases, increasing clinician awareness, and potential label expansion for broader indications.

2. How do safety concerns impact ICLUSIG’s market trajectory?
Adverse events, especially vascular occlusion, lead to cautious prescribing and impact market penetration. Effective safety management and clear guidelines are essential for sustained use.

3. What competitive threats does ICLUSIG face?
Emerging drugs like asciminib, which offer alternative mechanisms for resistant CML, threaten ICLUSIG’s market share. Established TKIs with better safety profiles also limit its use to specific resistant cases.

4. How significant is geographic expansion for ICLUSIG’s future?
Expanding into emerging markets and securing regulatory approvals internationally can diversify revenue sources and compensate for limited growth in developed countries.

5. What strategies can improve ICLUSIG’s revenue outlook?
Clinical trial data supporting earlier use, combination therapies, ongoing safety validation, and proactive stakeholder engagement are key strategies to bolster its financial trajectory.

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References

[1] Leibowitz, M., et al. (2021). "Epidemiology of Chronic Myeloid Leukemia." Leukemia Research, 101, 106399.