~ Buy the VONJO (pacritinib citrate) Drug Profile, 2024 PDF Report in the Report Store ~

VONJO Drug Patent Profile

When do Vonjo patents expire, and when can generic versions of Vonjo launch?

Vonjo is a drug marketed by Cti Biopharma Corp and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-seven patent family members in twenty-seven countries.

The generic ingredient in VONJO is pacritinib citrate. One supplier is listed for this compound. Additional details are available on the pacritinib citrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vonjo

Vonjo will be eligible for patent challenges on February 28, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 25, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VONJO

International Patents:	77
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	3
Drug Prices:	Drug price information for VONJO
What excipients (inactive ingredients) are in VONJO?	VONJO excipients list
DailyMed Link:	VONJO at DailyMed

See drug prices for VONJO

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

NDA:

208712

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 VONJO

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

US Patents and Regulatory Information for VONJO

VONJO is protected by six US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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
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			Y	Y

International Patents for VONJO

When does loss-of-exclusivity occur for VONJO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

South Africa

South Korea

Spain

Taiwan

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 VONJO around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1951730
Denmark	1951729
South Korea	20140117679	HETEROALKYL LINKED PYRIMIDINE DERIVATIVES
Russian Federation	2527970	ЦИТРАТ 11-(2-ПИРРОЛИДИН-1-ИЛ-ЭТОКСИ)-14,19-ДИОКСА-5,7,26-ТРИАЗАТЕТРАЦИКЛО[19.3.1.1(2,6).1(8,12)]ГЕПТАКОЗА-1(25),2(26),3,5,8,10,12(27),16,21,23-ДЕКАЕНА (11-(2-PYRROLIDIN-1-YL-ETHOXY)-14,19-DIOXA-5,7,26-TRIAZATETRACYCLO[19.3.1.1(2,6).1(8,12)]HEPTACOSA-1(25),2(26),3,5,8,10,12(27),16,21,23-DECAENE CITRATE)
Germany	602006014579

VONJO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VONJO (Pacritinib)

Introduction

VONJO, or pacritinib, is a novel oral kinase inhibitor developed by CTI BioPharma Corp. for the treatment of adult patients with intermediate or high-risk primary or secondary myelofibrosis and severe thrombocytopenia. Here, we delve into the market dynamics and financial trajectory of VONJO since its approval.

FDA Approval and Market Entry

VONJO received accelerated approval from the U.S. Food and Drug Administration (FDA) in February 2022, marking a significant milestone in the treatment of cytopenic myelofibrosis. This approval was under priority review, highlighting the urgent medical need for this patient population[2].

Clinical Significance

VONJO is the first approved therapy specifically addressing the needs of patients with cytopenic myelofibrosis, characterized by severe thrombocytopenia (platelet count below 50 × 10^9/L). This condition results in poor survival outcomes and debilitating symptoms, making VONJO a crucial addition to the treatment landscape[2].

Commercial Launch and Revenue Performance

Following its approval, VONJO was commercially launched in March 2022. The drug exceeded its year-end revenue goal, achieving $54 million in net sales for 2022, with $21.1 million generated in the fourth quarter alone. This represents a 16% increase compared to the third quarter of 2022[1].

Patient Adoption

As of the end of 2022, more than 1,000 patients had been treated with VONJO, a significant milestone for a rare disease. The commercial team's efforts to reinforce the clinical value proposition through peer-to-peer interactions and education have been instrumental in this adoption[1].

Insurance Coverage

VONJO has achieved over 90% insurance coverage with both Medicare and commercial plans, facilitating broader access to the treatment[1].

Financial Performance and Projections

Revenue Growth

In 2023, VONJO's revenue continued to grow, reaching approximately $67 million. This growth is a testament to the drug's market acceptance and the unmet medical need it addresses[4].

Operating and Net Loss

Despite the revenue growth, CTI BioPharma reported an operating loss of $79.8 million for the year ended December 31, 2022. This loss was partially offset by the revenue generated from VONJO sales. The decrease in operating loss compared to 2021 was primarily due to VONJO product sales, though it was also influenced by increased selling, general, and administrative activities related to the commercial launch[1].

Funding and Royalties

CTI BioPharma secured significant funding for the commercialization of VONJO through a transaction with DRI Healthcare Trust, which included $50 million in secured debt and up to $60 million in royalties on VONJO sales. This funding has been crucial for supporting the drug's launch and ongoing commercial activities[5].

Market Position and Competition

Unique Selling Proposition

VONJO's specificity for JAK2 and IRAK1 without inhibiting JAK1 sets it apart from other treatments, making it a valuable option for patients with cytopenic myelofibrosis. This unique profile has helped VONJO establish a niche in the market[2].

Competitive Landscape

The myelofibrosis treatment market is dominated by drugs like Jakafi (ruxolitinib), which has approvals across various indications and generates significantly higher revenues. However, VONJO's focus on a specific patient subset with severe thrombocytopenia positions it as a complementary rather than a direct competitor to Jakafi[4].

Future Outlook

Continued Growth

With ongoing efforts to increase market penetration and physician awareness, VONJO is expected to continue its revenue growth. The drug's inclusion in the National Comprehensive Cancer Network (NCCN) guidelines further supports its potential for increased adoption[1].

New Data and Clinical Trials

Presentations at conferences like the American Society of Hematology (ASH) 2022, featuring new data on pacritinib's benefits in myelofibrosis patients, will likely enhance the drug's clinical profile and attract more patients and prescribers[1].

Key Takeaways

• FDA Approval: VONJO received accelerated FDA approval in February 2022 for treating cytopenic myelofibrosis.
• Revenue Performance: Exceeded year-end revenue goal with $54 million in net sales in 2022 and $67 million in 2023.
• Patient Adoption: Over 1,000 patients treated with VONJO as of 2022.
• Insurance Coverage: Achieved over 90% insurance coverage.
• Financial Performance: Operating loss of $79.8 million in 2022, offset by VONJO sales.
• Funding and Royalties: Secured significant funding through DRI Healthcare Trust.
• Market Position: Unique selling proposition due to its specificity for JAK2 and IRAK1.

FAQs

What is VONJO used for?

VONJO (pacritinib) is used for the treatment of adult patients with intermediate or high-risk primary or secondary myelofibrosis and severe thrombocytopenia.

How much revenue did VONJO generate in 2022?

VONJO generated $54 million in net sales in 2022, with $21.1 million in the fourth quarter.

What sets VONJO apart from other myelofibrosis treatments?

VONJO is the first approved therapy specifically addressing the needs of patients with cytopenic myelofibrosis, and it does not inhibit JAK1, unlike other treatments.

How many patients have been treated with VONJO as of 2022?

Over 1,000 patients have been commercially treated with VONJO as of the end of 2022.

What is the current insurance coverage for VONJO?

VONJO has achieved over 90% insurance coverage with both Medicare and commercial plans.

Sources

1. CTI BioPharma Reports Fourth Quarter and Full Year 2022 Financial Results - PR Newswire
2. CTI BioPharma Announces FDA Accelerated Approval of VONJO (pacritinib) for the Treatment of Adult Patients with Myelofibrosis and Thrombocytopenia - PR Newswire
3. INCY.OQ - Q3 2022 Incyte Corp Earnings Call - Incyte Corporation
4. Myelofibrosis Treatment in 2024: New Horizons and Innovations - DelveInsight
5. CTI BioPharma and DRI Healthcare Trust Announce up to $135 Million Debt and Royalty Transaction - PR Newswire