PONATINIB HYDROCHLORIDE - Generic Drug Details

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

Ponatinib hydrochloride is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and Apotex, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ponatinib hydrochloride has one hundred and four patent family members in twenty-three countries.

There is one drug master file entry for ponatinib hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for PONATINIB HYDROCHLORIDE

International Patents:	104
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	62
Patent Applications:	517
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PONATINIB HYDROCHLORIDE
What excipients (inactive ingredients) are in PONATINIB HYDROCHLORIDE?	PONATINIB HYDROCHLORIDE excipients list
DailyMed Link:	PONATINIB HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PONATINIB HYDROCHLORIDE

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

Sponsor	Phase
Deutsche Leukämie- & Lymphom-Hilfe	Phase 2
Goethe University	Phase 2
German Federal Ministry of Education and Research	Phase 2

See all PONATINIB HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for PONATINIB HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 45MG BASE	TABLET;ORAL
		EQ 15MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PONATINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PONATINIB HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for PONATINIB HYDROCHLORIDE

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 PONATINIB HYDROCHLORIDE

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	203469-004	Dec 18, 2020		RX	Yes	No			Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes				Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes
Apotex	PONATINIB HYDROCHLORIDE	ponatinib hydrochloride	TABLET;ORAL	215893-001	Jul 14, 2023		DISCN	No	No

International Patents for PONATINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
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)
New Zealand	709648	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 mono hydrochloride salt
European Patent Office	1973545	COMPOSES HETEROARYLES BICYCLIQUES (BICYCLIC HETEROARYL COMPOUNDS)
Japan	6604739
Mexico	2008014290	COMPUESTOS HETEROARILICOS MONOCICLICOS. (MONOCYCLIC HETEROARYL COMPOUNDS.)
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	2021002261	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.)

Supplementary Protection Certificates for PONATINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1973545	1390059-2	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20261223 - 20280702
1973545	490	Finland
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	PA2013027	Lithuania		PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: EU/1/13/839/001, 2013 07 01 EU/1/13/839/002, 2013 07 01 EU/1/13/839/003, 2013 07 01 EU/1/13/839/004 20130701
1973545	C01973545/01	Switzerland		PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014
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	92327	Luxembourg		PRODUCT NAME: PONATINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE

PONATINIB HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ponatinib Hydrochloride

Introduction

Ponatinib hydrochloride, marketed under the name Iclusig, is a third-generation tyrosine kinase inhibitor (TKI) that has revolutionized the treatment of certain types of leukemia. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Mechanism of Action and Clinical Use

Ponatinib is a multi-targeted TKI with high potency against Philadelphia chromosome (Ph)-positive leukemias, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), particularly those with the T315I mutation that are resistant to first- and second-generation TKIs[2][5].

Market Size and Forecast

The global market for ponatinib drugs has been on an upward trend. As of 2023, the market was estimated to be worth US$ 592 million. It is forecasted to grow to US$ 902.8 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period of 2024-2030[1].

Segmentation by Application

The market is segmented primarily by application, with the main indications being CML and ALL. Ponatinib's efficacy in treating these conditions, especially in cases resistant to other TKIs, drives its market demand[1][4].

Segmentation by Product

The drug is available in two main dosages: 15mg and 45mg tablets. These different formulations cater to various patient needs and treatment protocols, contributing to the drug's market growth[3][4].

Geographical Segmentation

The market is geographically segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region presents unique market dynamics influenced by local healthcare systems, regulatory environments, and patient populations[4].

Key Players

ARIAD Pharmaceuticals, now part of Incyte Corporation, is the primary developer and marketer of ponatinib. Other companies involved in the development and distribution include Otsuka Pharmaceutical and Takeda[1][5].

Market Drivers

Several factors drive the growth of the ponatinib market:

• High Efficacy: Ponatinib's ability to treat Ph-positive leukemias, including those with the T315I mutation, makes it a critical treatment option.
• Increasing Incidence of Leukemia: The rising incidence of leukemia globally increases the demand for effective treatments.
• Advancements in Clinical Trials: Ongoing and future clinical trials exploring new indications and combination therapies will further boost the market[2][4].

Market Restraints

Despite the positive outlook, there are several restraints:

• Side Effects and Toxicities: Ponatinib is associated with cardiovascular risks and other toxicities, which can limit its use in some patients.
• Regulatory Conditions: The market authorization for ponatinib was issued with conditions, requiring ongoing monitoring and follow-up to confirm clinical benefits[3][4].

Competitive Landscape

The competitive landscape of the ponatinib market is characterized by a few key players. ARIAD Pharmaceuticals, now part of Incyte Corporation, holds a significant market share. Other companies, such as Otsuka Pharmaceutical and Takeda, are also involved in the development and distribution of ponatinib. The market is expected to see further competition as new TKIs and combination therapies are developed[1][4].

Financial Performance

The financial performance of the ponatinib market is robust, with a projected growth from US$ 592 million in 2023 to US$ 902.8 million by 2030. This growth is driven by increasing demand, expanded indications, and ongoing clinical trials that may open up new markets[1].

Regulatory Environment

Ponatinib has received regulatory approvals in several countries, including the United States and Canada. In Canada, it was approved under the Notice of Compliance with Conditions (NOC/c) Guidance, indicating the need for further follow-up to confirm clinical benefits[3].

Future Outlook

The future outlook for ponatinib is promising, with ongoing clinical trials exploring its use in solid tumors and other hematological malignancies. The drug's inclusion in new treatment protocols and its potential use in combination therapies are expected to drive further market growth[2][5].

Key Takeaways

• Market Growth: The ponatinib market is expected to grow from US$ 592 million in 2023 to US$ 902.8 million by 2030.
• CAGR: The market is forecasted to grow at a CAGR of 6.4% during the 2024-2030 period.
• Key Applications: CML and ALL are the primary indications driving market demand.
• Geographical Segmentation: The market is segmented into regions including North America, Europe, Asia-Pacific, and others.
• Regulatory Environment: Ponatinib has received approvals with conditions, requiring ongoing monitoring.

FAQs

What is ponatinib hydrochloride used for?

Ponatinib hydrochloride is used to treat Philadelphia chromosome-positive chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), particularly in cases resistant to other tyrosine kinase inhibitors[2].

Who are the main developers of ponatinib?

The main developers of ponatinib include ARIAD Pharmaceuticals (now part of Incyte Corporation), Otsuka Pharmaceutical, and Takeda[5].

What are the key drivers of the ponatinib market?

The key drivers include high efficacy against Ph-positive leukemias, increasing incidence of leukemia, and advancements in clinical trials exploring new indications and combination therapies[2][4].

What are the potential side effects of ponatinib?

Ponatinib is associated with cardiovascular risks and other toxicities, which can limit its use in some patients[3].

What is the projected market size of ponatinib by 2030?

The projected market size of ponatinib by 2030 is US$ 902.8 million, with a CAGR of 6.4% during the forecast period of 2024-2030[1].

Sources:

1. Valuates Reports: Ponatinib Drugs - Market, Report Size, Worth, Revenue, Growth ...
2. PubMed: Ponatinib-review of historical development, current status, and future ...
3. Health Canada: Summary Basis of Decision for Iclusig
4. Market Research Intellect: Global ponatinib market size and forecast
5. AdisInsight: Ponatinib - Incyte Corporation/Otsuka Pharmaceutical/Takeda