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 Sobi 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-eight patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for PACRITINIB CITRATE

International Patents:	78
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
DailyMed Link:	PACRITINIB CITRATE at DailyMed

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

Constraining patent/regulatory exclusivity:

8,980,873

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
Sobi	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes
Sobi	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes
Sobi	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes	8,980,873		Y	Y
Sobi	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes	8,153,632		Y	Y
Sobi	VONJO	pacritinib citrate	CAPSULE;ORAL	208712-001	Feb 28, 2022		RX	Yes	Yes	9,573,964

International Patents for PACRITINIB CITRATE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1124040	HETEROALKYL LINKED PYRIMIDINE DERIVATIVES
Australia	2006316072	Heteroalkyl linked pyrimidine derivatives
Canada	2629443
Slovenia	1951729
Brazil	PI0618552
South Korea	101568801
Argentina	074724

Market Dynamics and Financial Trajectory for PACRITINIB CITRATE

Last updated: July 27, 2025

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Introduction

Pacritinib citrate, an oral kinase inhibitor designed for the treatment of myelofibrosis and other hematologic malignancies, has emerged as a notable development in the pharmaceutical landscape. Understanding the market dynamics and financial trajectory surrounding this novel agent offers critical insights for investors, healthcare providers, and industry stakeholders. This analysis delineates the competitive environment, regulatory pathway, market potential, and associated financial projections of pacritinib citrate.

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Pharmacological Profile and Therapeutic Indication

Pacritinib citrate is a selective JAK2 and IRAK1 inhibitor, distinguished by its unique profile that targets aberrant signaling pathways implicated in myelofibrosis—a chronic myeloproliferative disorder characterized by fibrosis of the bone marrow, anemia, and enlarged spleen. Unlike other JAK inhibitors, pacritinib is designed to mitigate issues related to thrombocytopenia, a common side effect among the class, making it a promising candidate for patients with low platelet counts.

The drug’s primary indication is for intermediate- or high-risk myelofibrosis, especially in cases where thrombocytopenia limits the use of other JAK inhibitors such as ruxolitinib. This niche positioning is integral to its market potential.

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Market Landscape and Competitive Environment

Current Market Dynamics

The global myelofibrosis treatment landscape is characterized by a limited number of approved therapies—predominantly ruxolitinib (Jakafi). The unmet medical need for agents that address thrombocytopenia has positioned pacritinib as a potentially transformative treatment option.

Key Competitors

• Ruxolitinib (Incyte and Novartis): Dominates current treatment but is limited by hematologic adverse effects.
• Fedratinib (Incyte): Approved for patients intolerant to ruxolitinib, but with different side-effect profiles.
• Emerging Agents: Several pipeline drugs are in development, yet none has yet established a clear foothold due to late-stage clinical hurdles or limited indication scope.

Regulatory Environment

Pacritinib’s journey has been marked by regulatory scrutiny. Formerly discontinued from FDA approval due to safety concerns, subsequent studies have reassessed its risk-benefit profile, leading to the resumption of development activities. As of 2023, regulatory agencies have demonstrated a cautious yet open stance towards its approval under certain conditions, influenced heavily by data confirming manageable safety profiles and significant efficacy.

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Market Potential and Adoption Drivers

Patient Population

The global prevalence of myelofibrosis is estimated at approximately 4.9 per 100,000 individuals, with higher rates among older adults. With an aging population worldwide, the patient pool poised for treatment expansion is projected to grow steadily.

Unmet Need & Differentiators

Pacritinib holds an advantage in serving patients with thrombocytopenia—a subset underserved by existing therapies. Its safety profile, if conclusively established, could lead to wider adoption.

Pricing and Reimbursement

Pricing strategies will hinge upon comparative efficacy, safety, and the value proposition relative to existing therapies. In markets like the U.S. and Europe, reimbursement considerations will critically influence market penetration.

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Financial Trajectory and Revenue Forecast

Developmental Milestones and Investment

Recent phases of clinical trials, including pivotal studies like PERSIST-2, have been critical. Ongoing or planned regulatory submission processes imply substantial investment, with costs attributed to clinical development, manufacturing scale-up, and regulatory compliance.

Revenue Projections

Assuming successful regulatory approval, the initial launch could generate revenues in the range of $300 million to $600 million globally within the first 3-5 years, based on analogous treatments and market size estimates. Revenue growth will depend on the pace of market adoption, competitive responses, and geographic expansion.

Risks and Financial Variables

Key risks include clinical setbacks, regulatory delays, and safety concerns, which could substantially dampen revenue prospects. Conversely, positive trial outcomes and strategic partnerships could accelerate revenue growth.

Partnerships and Market Expansion

Strategic alliances with healthcare entities or licensing agreements can significantly impact both development costs and revenue inflows. Expanding into emerging markets also offers potential upside.

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Regulatory and Patent Outlook

Intellectual Property Rights

Patent protection around pacritinib citrate is expected to secure exclusivity for at least 10-15 years, covering the formulation, delivery mechanisms, and specific dosing regimens.

Regulatory Pathways

Fast-track designations or qualifying for orphan drug status could expedite approval timelines, influencing financial forecasts favorably.

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Conclusion

Pacritinib citrate stands at a pivotal juncture within the hematologic malignancies sphere. Its ability to carve a niche based on safety and efficacy advantages could significantly propel its market penetration. The financial trajectory hinges on successful navigation through regulatory channels, market acceptance, and competitive dynamics. As the therapeutic landscape evolves, pacritinib has the potential to become a lucrative asset for stakeholders willing to navigate its developmental complexities.

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Key Takeaways

• Pacritinib citrate addresses a critical unmet need for myelofibrosis patients with thrombocytopenia, differentiating it from existing treatments.
• Regulatory developments and trial outcomes will be decisive in shaping its market entry and acceptance.
• The drug’s market potential is substantial given the growing patient population and limited current therapies.
• Strategic partnerships, pricing strategies, and reimbursement policies will directly influence revenue growth.
• Vigilant risk management—including safety monitoring and regulatory engagement—is essential for sustained financial success.

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FAQs

1. What are the primary clinical advantages of pacritinib citrate over existing myelofibrosis treatments?
Pacritinib citrate offers targeted inhibition of JAK2 and IRAK1, providing efficacy especially in patients with severe thrombocytopenia—a subgroup less suited to current JAK inhibitors like ruxolitinib due to hematologic toxicity.

2. How does regulatory uncertainty impact the financial prospects of pacritinib citrate?
Uncertainty can delay approval, increasing development costs and postponing revenue realization. Conversely, positive trial results and favorable regulatory feedback can unlock market potential and improve valuation.

3. What factors influence the pricing strategy of pacritinib citrate?
Efficacy, safety profile, competitive landscape, patient affordability, and reimbursement frameworks are key considerations. Its value proposition hinges on clinical advantages over existing therapies.

4. How significant is the generic risk for pacritinib citrate after patent expiration?
Like most innovator drugs, patent expiration could lead to generic competition, potentially reducing revenues. Strategic patent extensions and secondary patents are critical to maintaining market exclusivity.

5. What emerging markets present opportunities for the expansion of pacritinib citrate?
Emerging markets with increasing adoption of novel hematologic therapies and growing healthcare infrastructure, such as China, India, and parts of Latin America, hold considerable potential for expansion.

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Sources:

[1] Global Myelofibrosis Market Analysis, 2022-2030.
[2] FDA and EMA Regulatory Pathways for Hematology Drugs.
[3] Clinical Data on Pacritinib (PERSIST-2 trial results), 2021.
[4] Market Size and Epidemiology of Myelofibrosis, Hematology Reports, 2022.
[5] Pharmaceutical Patent Lifecycle and Protection Strategies.