Pacritinib citrate - Generic Drug Details

What are the generic drug sources for pacritinib citrate and what is the scope of patent protection?

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

International Patents for pacritinib citrate

Country	Patent Number	Title	Estimated Expiration
Slovenia	1951730
European Patent Office	1951730	DERIVES DE PYRIMIDINE A LIAISON HETEROALKYLE (HETEROALKYL LINKED PYRIMIDINE DERIVATIVES)
Hong Kong	1123282	氧連接的嘧啶衍生物 (OXYGEN LINKED PYRIMIDINE DERIVATIVES)

Market Dynamics and Financial Trajectory for PACRITINIB CITRATE

Last updated: March 4, 2026

What is the current development status of PACRITINIB CITRATE?

PACRITINIB CITRATE is an orally available Janus kinase (JAK) inhibitor targeting immune-related disorders. Its development has been evaluated primarily for myelofibrosis, polycythemia vera, and other hematological malignancies. As of latest updates, the drug is in Phase 2 clinical trials, with no approved marketing authorization in the United States or Europe.

How does PACRITINIB CITRATE compare to competitors?

Drug Name	Target Enzyme	Phase	Indications	Marketed	Key Competitors
PACRITINIB CITRATE	JAK1/JAK2	2	Myelofibrosis, Polycythemia vera	No	Ruxolitinib (Jakafi), Fedratinib
Ruxolitinib	JAK1/JAK2	Approved	Myelofibrosis, Polycythemia vera	Yes	Fedratinib, Momelotinib
Fedratinib	JAK2	Approved	Myelofibrosis, Essential thrombocythemia	Yes	Ruxolitinib

PACRITINIB is positioned as a potentially more selective JAK1/2 inhibitor, with a distinct side effect profile. Its competitive advantage depends on efficacy, safety, and tolerability demonstrated in clinical trials.

What are the market size and growth projections?

Hematology market size:

• Estimated global market value in 2022: $8.5 billion (Grand View Research[1])
• Compound annual growth rate (CAGR) expected: 8% until 2030.

JAK inhibitor segment:

• Accounts for over 70% of hematology drug sales.
• Expected to reach $5.3 billion by 2025, driven by new entrants and expanding indications (BI Research[2]).

Key regions:

• North America: Largest market, driven by high prevalence of hematologic disorders and reimbursement coverage.
• Europe: Second-largest, with gradual adoption of new therapies.
• Asia-Pacific: Fastest-growing segment, fueled by increasing healthcare expenditure.

What are the financial risks and opportunities?

Risks:

• Clinical trial failures could delay or prevent market entry.
• Competition from Ruxolitinib and Fedratinib, which have established market presence.
• Regulatory hurdles, especially regarding safety profile and side effects.
• Pricing pressures and reimbursement limitations.

Opportunities:

• Differentiation through improved safety or efficacy profiles.
• Expanded indications, including autoimmune diseases.
• Strategic partnerships with biopharma firms and healthcare providers.
• Market exclusivity granted by patents, potentially spanning 10-12 years from filing.

Projected revenues:

• No current revenue forecasts due to developmental phase.
• Potential peak sales estimates vary from $500 million to over $2 billion, contingent on approval success and market penetration (EvaluatePharma[3]).

What is the timeline for commercialization?

Milestone	Expected Date
Phase 2 completion	2024
NDA submission (if successful)	2025
Market launch	2026-2027

Delay risks include prolonged trial durations or regulatory setbacks.

Summary of market dynamics

• The JAK inhibitor market remains competitive with established drugs.
• Pacritinib’s development hinges on demonstrating superior safety and efficacy.
• The market shows steady growth, especially in emerging regions.
• Commercial success depends on clinical outcomes, regulatory approval, and strategic positioning.

Key Takeaways

• PACRITINIB CITRATE is a late-phase candidate with targeted advantages but faces significant competition.
• The hematology drug market is expanding, with JAK inhibitors leading growth.
• Key regions like North America dominate sales, but Asia-Pacific presents rapid growth opportunities.
• The pipeline’s success relies on effective clinical data and regulatory clearance.
• Commercial viability requires overcoming market entry barriers and differentiation.

FAQs

1. What diseases is PACRITINIB CITRATE primarily targeting?
   It targets hematologic disorders such as myelofibrosis and polycythemia vera.

2. When is PACRITINIB expected to be commercialized?
   Estimated launch between 2026 and 2027, depending on clinical trial outcomes and regulatory review.

3. How does PACRITINIB compare to Ruxolitinib?
   It aims for improved selectivity and reduced side effects; however, comparative efficacy data is pending.

4. What are the main risks facing commercialization?
   Clinical trial failure, high competition, regulatory hurdles, and pricing pressures.

5. What is the potential market size for PACRITINIB?
   Peak sales could reach over $1 billion if approved and adopted broadly, pending competitive positioning.

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References

[1] Grand View Research. (2022). Hematology Market Size, Share & Trends Analysis Report.
[2] BI Research. (2021). JAK Inhibitors Market Outlook.
[3] EvaluatePharma. (2022). Oncology & Hematology Forecasts.