Drug Sales Trends for OTREXUP

Annual Sales Revenues and Units Sold for OTREXUP

These sales figures are drawn from a US national survey of drug expenditures

Drug Name	Revenues (USD)	Units	Year
OTREXUP			2021
OTREXUP			2020
OTREXUP			2019

Market Analysis and Sales Projections for Otrexup (Methotrexate)

Introduction to Otrexup

Otrexup is a drug-device combination product that contains methotrexate, a well-established medication used in the treatment of various conditions including rheumatoid arthritis, psoriasis, and certain types of cancer. The product is delivered via a single-dose, once-weekly auto-injector called the VIBEX auto-injector®[3].

Market Drivers

The market for Otrexup is driven by several key factors:

Increasing Prevalence of Rheumatoid Arthritis and Other Indications

The global prevalence of rheumatoid arthritis, psoriasis, and cancer is on the rise, which increases the demand for effective treatments like methotrexate. For instance, rheumatoid arthritis affects around 1.3 million adults in the US and up to 1% of the global population, with women being two to three times more likely to be affected than men[4].

Efficacy and Convenience

Otrexup's auto-injector format offers higher efficacy and greater convenience compared to oral methotrexate, making it a preferred choice for patients and healthcare providers. This format also enhances patient compliance, which is crucial for the effective management of chronic conditions[3].

Regulatory and Patent Landscape

Otrexup has a robust patent protection, with the last Orange Book listed patent expiring in May 2031. This extended patent life provides a significant competitive advantage and protects the product from generic competition for several years[3].

Market Segmentation

By Formulation

The injectable formulation of methotrexate, such as Otrexup, is expected to dominate the market segment due to its higher efficacy compared to oral formulations. The convenience and ease of use of the auto-injector further contribute to its market share[1].

By Indication

Cancer treatment is expected to be the leading indication for methotrexate, including Otrexup, due to its widespread use in oncology. However, rheumatoid arthritis and psoriasis also constitute significant market segments[1].

By End-User

Hospitals are anticipated to be the primary end-users of Otrexup, given the advanced facilities and high treatment costs associated with these settings. This is followed by clinics and other healthcare facilities[1].

Regional Outlook

North America

North America, particularly the United States, is the largest market for Otrexup. This region benefits from a high prevalence of rheumatoid arthritis and other indications, advanced healthcare infrastructure, and the presence of key players in the pharmaceutical industry[1].

Europe

Europe holds the second-largest market share, driven by a large patient base and advanced healthcare infrastructure. However, the market here is expected to experience marginal growth due to the launch of biosimilars and other cost-effective alternatives[4].

Asia Pacific

The Asia Pacific region is expected to grow at the fastest pace, driven by a large patient pool, advancing research and healthcare infrastructure, and increasing awareness about available treatments[1].

Latin America and Middle East & Africa

These regions are expected to grow gradually, with Latin America benefiting from increasing awareness and progressing healthcare infrastructure, while the Middle East & Africa face challenges due to lagging healthcare infrastructure and lack of awareness[1].

Sales Projections

Recent Performance

Otrexup generated $15.5 million in revenues over the trailing 12 months ended September 30, 2021. This performance indicates a stable demand for the product[2][3].

Future Growth

With the acquisition by Assertio Holdings, Otrexup is expected to see significant growth. Assertio plans to invest in further commercialization, leveraging its unique digital platform and expertise to drive sales. The company anticipates Otrexup to be a growth driver, contributing to its goal of achieving at least $50 million in gross profit by 2024[2][3].

Financial Guidance

Assertio Holdings has raised its full-year net product sales and non-GAAP adjusted EBITDA guidance following the acquisition of Otrexup. The updated guidance includes net product sales greater than $108 million and adjusted EBITDA greater than $48 million for the year 2021[2].

Competitive Landscape

The market for methotrexate and similar treatments is competitive, with other drugs and molecules vying for market share. However, Otrexup's unique delivery system and extended patent protection provide a competitive edge. The divestiture of Otrexup by Antares Pharma to Assertio Holdings also reflects a strategic focus on other product lines, such as urology and endocrinology products, which could reduce competition in the methotrexate market[5].

Challenges and Opportunities

Adverse Effects

One of the significant challenges facing Otrexup is the potential for adverse effects associated with methotrexate, such as dizziness, hair loss, and reduced renal function at high doses. These side effects can impact patient compliance and overall market growth[1].

Regulatory Changes

Regulatory changes, such as the FDA's restrictions on the use of JAK inhibitors due to safety concerns, can impact the broader market for rheumatoid arthritis treatments. However, methotrexate remains a first-line treatment and is less likely to be affected by these changes[4].

Biosimilar Launches

The launch of biosimilars during the forecast period could pose a challenge to Otrexup's market share, especially in regions where cost is a significant factor. However, the convenience and efficacy of Otrexup's auto-injector format are expected to maintain its market position[4].

Key Takeaways

• Growing Demand: Increasing prevalence of rheumatoid arthritis, psoriasis, and cancer drives the demand for Otrexup.
• Convenience and Efficacy: The auto-injector format of Otrexup offers higher efficacy and greater convenience, enhancing patient compliance.
• Robust Patent Protection: Extended patent life until May 2031 protects Otrexup from generic competition.
• Regional Growth: North America leads the market, with Asia Pacific expected to grow at the fastest pace.
• Acquisition and Commercialization: Assertio Holdings' acquisition and planned investment in Otrexup are expected to drive significant growth.

FAQs

Q: What is Otrexup used for? A: Otrexup is used for the treatment of rheumatoid arthritis, psoriasis, and certain types of cancer.

Q: What is the unique feature of Otrexup? A: Otrexup is delivered via a single-dose, once-weekly auto-injector called the VIBEX auto-injector®, which offers higher efficacy and greater convenience compared to oral methotrexate.

Q: Who acquired Otrexup and why? A: Assertio Holdings acquired Otrexup from Antares Pharma to leverage its unique digital platform and expertise for further commercialization and growth.

Q: What are the potential challenges facing Otrexup? A: Adverse effects associated with methotrexate, regulatory changes, and the launch of biosimilars are potential challenges.

Q: What is the projected growth for the Otrexup market? A: The market is expected to grow significantly, with Assertio Holdings aiming to achieve at least $50 million in gross profit by 2024 through the commercialization of Otrexup.

Sources

1. Biospace: Methotrexate Market is expected to grow further with its Increasing application in the treatment of cancer and arthritis.
2. GlobeNewswire: Assertio Holdings, Inc. Announces the Acquisition of Otrexup (methotrexate) a Drug Device Combination from Antares Pharma, Inc.
3. Biospace: Assertio Holdings, Inc. Announces the Acquisition of Otrexup (methotrexate) a Drug Device Combination from Antares Pharma, Inc.
4. iHealthcareAnalyst: Global Rheumatoid Arthritis Drugs Market $53.1 Billion by 2031.
5. Stock Titan: Antares Pharma Announces Divestiture of Otrexup.