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 five patent family members in twenty-three 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 two 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:	105
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	25
Patent Applications:	256
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
University of Chicago	Phase 2
CZECRIN - Czech Clinical Research Infrastructure Network	Phase 2
Institute of Hematology and Blood Transfusion, Czech Republic	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			Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No				Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No			Y	Y

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
Canada	3022250	FORMES CRISTALLINES DE 3-(IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-{4-[(4-METHYLPIPERAZ IN-1-YL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL}BENZAMIDE MONO HYDROCHLORIDE (CRYSTALLINE FORMS OF 3-(IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-{4-[(4-METHYLPIPERAZIN-1-YL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL}BENZAMIDE MONO HYDROCHLORIDE)
Mexico	2021002256	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	7352841
European Patent Office	2495016	Composants hétéroaromatiques bicycliques (Bicyclic Heteroaryl Compounds)

Supplementary Protection Certificates for ICLUSIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1973545	490	Finland
1973545	CR 2013 00066	Denmark		PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING THE HYDROCHLORIDE SALT THEREOF; REG. NO/DATE: EU/1/13/839/001-004 20130701
1973545	1390059-2	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20261223 - 20280702
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

Market Dynamics and Financial Trajectory for ICLUSIG

Introduction to ICLUSIG

ICLUSIG, a targeted therapy developed by Takeda Pharmaceuticals (originally by Ariad Pharmaceuticals), has revolutionized the treatment of certain types of cancer, particularly chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Here, we delve into the market dynamics and financial trajectory of ICLUSIG, highlighting its growth, market impact, and future prospects.

Growing Demand for Targeted Therapies

The global cancer treatment market has seen significant growth driven by rising cancer incidence, innovations in oncology therapies, and the increasing availability of targeted treatments. ICLUSIG is at the forefront of this trend, benefiting from the surge in demand for targeted therapies that specifically aim at cancer cells, minimizing damage to healthy tissues[1].

Market Expansion and Global Reach

ICLUSIG's market is expanding rapidly, particularly in developed markets such as the U.S., Europe, and Japan, where advanced healthcare infrastructure and high healthcare spending facilitate the adoption of innovative treatments. The U.S. alone accounts for a significant share of the global oncology market, and ICLUSIG has been recognized as a valuable option for resistant leukemia cases[1].

In addition to developed markets, ICLUSIG's adoption is also on the rise in emerging markets, including the Asia-Pacific and Latin America regions. As healthcare systems in these regions improve and access to advanced cancer treatments becomes more feasible, the market for ICLUSIG is expected to expand further[1].

Research and Development

Continuous research and development (R&D) are crucial for the growth of ICLUSIG. New clinical trials are exploring the use of ICLUSIG in combination with other therapies for various cancers, including solid tumors and non-Hodgkin lymphoma. If successful, these trials could open up entirely new markets for the drug, driving demand even further[1].

Financial Performance

Revenue Growth

The financial performance of ICLUSIG has been robust. In 2018, GAAP net product revenues from ICLUSIG were $80 million, compared to $67 million in the previous year. This growth trend has continued, with total revenues from oncology drugs, including ICLUSIG, contributing significantly to the overall revenue of pharmaceutical companies involved[5].

Recent Financial Trends

In the second quarter of 2024, Incyte, a company involved in the distribution and development of various oncology drugs, reported total revenues that grew 9% year-over-year, surpassing $1.0 billion. While the specific revenue from ICLUSIG was not detailed, the overall growth in oncology drug revenues indicates a positive financial trajectory for targeted therapies like ICLUSIG[2].

Costs and Expenses

The financial reports also highlight the costs associated with the development and marketing of ICLUSIG. Selling, general, and administrative expenses have increased due to factors such as acquisition-related compensation and consumer marketing activities. However, excluding these upfront costs, the expenses have remained relatively flat, indicating efficient management of operational costs[2].

Market Competition and Dynamics

Competitive Landscape

The hematology-oncology market is highly competitive, with several drugs vying for market share. ICLUSIG competes with other notable drugs like BRUKINSA®, IMBRUVICA®, VENCLEXTA®, and CALQUENCE®. Recent data shows a significant decline in the dominance of IMBRUVICA® as new drugs enter the market, with BRUKINSA® demonstrating remarkable growth and VENCLEXTA® emerging as the leading therapeutic[4].

Demographic Insights

Demographic analysis reveals that Medicare is the dominant payer for most prescriptions, and non-Hispanic Whites make up the largest percentage of the treated population. Treated patients are also more likely to be male, aligning with higher incidence rates of blood cancers among these demographics[4].

Partnerships and Collaborations

Partnerships between pharmaceutical companies and healthcare providers are crucial for accelerating the development and approval of new cancer drugs. Collaborations involving ICLUSIG could help bring new treatment combinations to market faster, benefiting both patients and investors. Mergers and acquisitions in the pharmaceutical industry can also lead to the expansion of a product’s market presence, potentially making ICLUSIG more accessible and affordable in emerging markets[1].

Investment Potential

Biotech investors are keenly interested in targeted cancer therapies like ICLUSIG. As healthcare systems prioritize cancer treatment, there is significant potential for companies manufacturing and distributing such drugs to see strong returns on investment. The global expansion of personalized medicine is also expected to drive long-term growth in the market for drugs like ICLUSIG[1].

Future Prospects

The future of ICLUSIG looks promising, with ongoing research into new formulations and therapeutic combinations. The drug's effectiveness and applicability are being broadened through clinical trials, which will optimize treatment outcomes as the understanding of cancer biology evolves. The market for ICLUSIG is projected to experience substantial growth between 2024 and 2032, driven by increasing demand for advanced cancer therapies and improvements in healthcare infrastructure in emerging markets[3].

Key Takeaways

• Growing Demand: ICLUSIG benefits from the rising demand for targeted therapies in oncology.
• Global Reach: The drug is expanding its market presence in both developed and emerging markets.
• R&D: Continuous research and development are key to opening new markets for ICLUSIG.
• Financial Performance: Revenue growth and efficient cost management indicate a positive financial trajectory.
• Market Competition: ICLUSIG competes in a dynamic market with shifting clinical preferences and demographic variations.
• Partnerships: Collaborations are essential for accelerating drug development and market expansion.
• Investment Potential: Strong potential for returns on investment due to the growing importance of targeted therapies.

FAQs

Q: What types of cancer does ICLUSIG treat?

ICLUSIG is used to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), particularly in patients who have developed resistance or intolerance to other treatments[1].

Q: Why is ICLUSIG preferred over traditional chemotherapy?

ICLUSIG is preferred because it specifically targets cancer cells, minimizing damage to healthy tissues and resulting in fewer side effects and better efficacy compared to traditional chemotherapy[1].

Q: What regions are seeing the most growth in ICLUSIG adoption?

ICLUSIG's adoption is on the rise in both developed markets like the U.S., Europe, and Japan, and in emerging markets such as the Asia-Pacific and Latin America regions[1].

Q: How does ICLUSIG compete in the hematology-oncology market?

ICLUSIG competes with other drugs like BRUKINSA®, IMBRUVICA®, VENCLEXTA®, and CALQUENCE®, with market dynamics shifting as new drugs enter the market and clinical preferences evolve[4].

Q: What are the future prospects for ICLUSIG?

The future of ICLUSIG looks promising with ongoing research, new therapeutic combinations, and projected substantial growth between 2024 and 2032 driven by increasing demand for advanced cancer therapies[3].

Sources

1. Market Research Intellect: "Iclusig Market Size And Projection - Market Research Intellect"
2. Incyte: "Incyte Reports 2024 Second Quarter Financial Results and Provides Business Update"
3. Wicz: "Iclusig Market Size Insights Report 2024-2032 | 92 Pages Report"
4. Komodo Health: "Drug Snapshot: Shifting Paradigms in Hematology-Oncology"
5. Incyte: "Incyte Reports 2018 Fourth Quarter and Year-End Financial Results"

Last updated: 2024-12-16