PACRITINIB CITRATE - Generic Drug Details

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

Pacritinib citrate is the generic ingredient in one branded drug marketed by Cti Biopharma Corp and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pacritinib citrate has seventy-seven patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for PACRITINIB CITRATE

International Patents:	77
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	4
DailyMed Link:	PACRITINIB CITRATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PACRITINIB CITRATE

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for PACRITINIB CITRATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 3A4 Inhibitors Janus Kinase Inhibitors Organic Cation Transporter 1 Inhibitors P-Glycoprotein Inhibitors Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PACRITINIB CITRATE

L01EJ	Janus-associated kinase (JAK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for PACRITINIB CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cti Biopharma Corp	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes			Y	Y
Cti Biopharma Corp	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes
Cti Biopharma Corp	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes			Y	Y
Cti Biopharma Corp	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes

International Patents for PACRITINIB CITRATE

Country	Patent Number	Title	Estimated Expiration
Japan	5225856
South Korea	20140037256	OXYGEN LINKED PYRIMIDINE DER??ATIVES
South Korea	20140117679	HETEROALKYL LINKED PYRIMIDINE DERIVATIVES
Hong Kong	1124040	HETEROALKYL LINKED PYRIMIDINE DERIVATIVES

PACRITINIB CITRATE Market Analysis and Financial Projection Experimental

Pacritinib Citrate: Market Dynamics and Financial Trajectory

Introduction

Pacritinib citrate, marketed as Vonjo, is a Janus kinase (JAK) inhibitor that has recently gained significant attention for its efficacy in treating myelofibrosis, a type of blood cancer. Here, we delve into the market dynamics and financial trajectory of pacritinib, highlighting its growth drivers, regional performance, and future prospects.

Market Size and Growth Projections

The global pacritinib market is poised for substantial growth. As of 2024, the market size is estimated at USD XX million and is expected to expand at a compound annual growth rate (CAGR) of 8.00% from 2024 to 2031, reaching USD XX million by 2031[1].

Regional Market Performance

North America

North America holds a significant share of the global pacritinib market, accounting for more than 40% of the global revenue. The region is expected to grow at a CAGR of 6.2% from 2024 to 2031. The United States, in particular, will see a CAGR of 6%, while Canada and Mexico will experience growth rates of 7% and 6.7%, respectively[1].

Europe

Europe also constitutes a major market for pacritinib, with over 30% of the global revenue. The European market is projected to grow at a CAGR of 6.5% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region is experiencing rapid growth, driven by the increasing prevalence of myelofibrosis and other hematologic disorders. This region holds around 23% of the global revenue and is expected to grow at a CAGR of 10.0% from 2024 to 2031. Countries like India and Australia are leading this growth, with CAGRs of 11.8% and 9.7%, respectively[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also show promising growth, with CAGRs of 7.4% and 7.7%, respectively, from 2024 to 2031. These regions, although smaller, are crucial for the drug's global expansion[1].

Clinical Trials and Regulatory Approvals

FDA Approval

Pacritinib received accelerated approval from the FDA in February 2022 for the treatment of select adult patients with intermediate or high-risk primary or secondary myelofibrosis. This approval was based on the results of the phase 3 PERSIST-1 and PERSIST-2 trials, as well as the phase 2 PAC203 trial. The drug has shown significant efficacy in reducing spleen volume and symptom scores compared to best available therapy (BAT)[2].

Ongoing Clinical Trials

The phase 3 PACIFICA trial is ongoing and expected to provide confirmatory findings by mid-2025. This trial is crucial for the full approval of pacritinib and will further solidify its position in the market[2].

Market Drivers

Increasing Prevalence of Myelofibrosis

The rising incidence of myelofibrosis and related hematologic disorders is a key driver of the pacritinib market. Myelofibrosis affects approximately 21,000 patients in the United States alone, with a significant portion experiencing cytopenias, making pacritinib a critical treatment option[2].

Advancements in Clinical Research

Ongoing clinical trials are exploring new applications and combinations of pacritinib, expanding its potential indications beyond myelofibrosis. This includes research into other hematologic conditions and combination therapies, which are expected to enhance the drug's efficacy and market reach[4].

Regulatory Endorsements

Recent regulatory approvals in various countries have bolstered pacritinib’s market presence. The inclusion of pacritinib in the National Comprehensive Cancer Network (NCCN) guidelines as a recommended treatment for myeloproliferative neoplasms further enhances its credibility and acceptance among healthcare providers[5].

Financial Trajectory

Investment Opportunities

The market forecast for pacritinib indicates robust growth, making it an attractive investment opportunity. The drug's expanding indications, favorable clinical trial results, and ongoing research are expected to increase its market value. Pharmaceutical companies are actively seeking partnerships and acquisitions to enhance their portfolios, which includes investments in pacritinib[4].

Revenue Growth

The revenue growth of pacritinib is expected to be driven by its increasing adoption in various regions and its expanding indications. As more patients gain access to this treatment, the market size is anticipated to grow significantly.

Challenges and Risks

Adverse Effects

Pacritinib is associated with several adverse effects, including serious and fatal hemorrhages, particularly in patients with low platelet counts. Other risks include worsening thrombocytopenia, prolonged QTc intervals, and increased risk of major adverse cardiac events and infections. These risks necessitate careful patient selection and monitoring[5].

Competition

The JAK inhibitor market is competitive, with other drugs like ruxolitinib (Jakafi) already established. However, pacritinib's unique profile, particularly its efficacy in patients with severe thrombocytopenia, sets it apart and provides a competitive edge[2].

Strategic Partnerships and Collaborations

Pharmaceutical companies involved with pacritinib are exploring strategic alliances to accelerate research and expand market reach. These collaborations aim to leverage combined expertise and resources to advance the development and commercialization of pacritinib[4].

Future Prospects

Pacritinib is poised to play a significant role in the treatment of hematologic cancers, particularly myelofibrosis. With ongoing research into new indications and combination therapies, the drug's market potential is expected to continue expanding. The Asia Pacific region, in particular, is anticipated to be a key growth driver due to its rapidly expanding healthcare infrastructure and increasing healthcare expenditure[1].

"Pacritinib’s rapid expansion is driven by its targeted therapeutic approach, growing market demand, and ongoing innovations in research and development. As it continues to evolve, pacritinib is set to play a significant role in the treatment of hematologic cancers, offering valuable opportunities for investors and healthcare providers alike."[4]

Key Takeaways

• Market Growth: The global pacritinib market is expected to grow at a CAGR of 8.00% from 2024 to 2031.
• Regional Performance: North America, Europe, and the Asia Pacific are key regions driving the market growth.
• Clinical Trials: Ongoing trials, including the phase 3 PACIFICA trial, are crucial for the drug's full approval and expanded indications.
• Regulatory Approvals: Recent FDA approval and inclusion in NCCN guidelines have bolstered the drug's market presence.
• Financial Trajectory: The drug presents attractive investment opportunities due to its expanding indications and favorable clinical trial results.
• Challenges: Adverse effects and competition from other JAK inhibitors are key challenges.

FAQs

What is pacritinib used for?

Pacritinib is used for the treatment of intermediate or high-risk primary or secondary myelofibrosis, particularly in patients with severe thrombocytopenia.

What are the key regions driving the growth of the pacritinib market?

The key regions driving the growth of the pacritinib market include North America, Europe, and the Asia Pacific.

What are the major adverse effects associated with pacritinib?

Pacritinib is associated with serious and fatal hemorrhages, worsening thrombocytopenia, prolonged QTc intervals, and increased risk of major adverse cardiac events and infections.

What is the current regulatory status of pacritinib?

Pacritinib received accelerated FDA approval in February 2022 and is included in the NCCN guidelines as a recommended treatment for myeloproliferative neoplasms.

What are the future prospects for pacritinib in the pharmaceutical market?

Pacritinib is expected to continue expanding its market presence due to ongoing research into new indications, combination therapies, and strategic partnerships.

Sources

1. Cognitive Market Research. Global Pacritinib Market Report 2024.
2. Onclive. FDA Approves Pacritinib for Intermediate- or High-Risk Myelofibrosis.
3. Wiley Online Library. LLM 2024 Abstracts.
4. Market Research Intellect. Pacritinib Market Dynamics: Uncovering the Factors Behind Its Rapid Expansion.
5. AJMC. NCCN Recommends Pacritinib for Treatment of Myeloproliferative Neoplasms.