Bristol Myers' Leukemia Drug to Face Generic Competition

Pharmaceutical companies are confronting a significant challenge known as the "patent cliff," where the expiration of patents threatens to reduce sales of some of their most lucrative drugs due to the introduction of generic alternatives. One such company, Bristol Myers Squibb, is particularly vulnerable with its leukemia drug, Sprycel, facing imminent competition.

Sprycel, also known by its chemical name dasitinib, is a kinase inhibitor used to treat chronic myeloid leukemia (CML). Approved in 2006, it has been a consistent revenue generator for Bristol Myers, achieving global sales of $1.9 billion in 2023 and surpassing $2.1 billion in both 2022 and 2021. However, the arrival of generic versions threatens to erode these figures.

Legal disputes have marked the recent landscape for Sprycel. Bristol Myers has been involved in several patent infringement lawsuits aimed at protecting its market share. In 2022, the company filed a lawsuit against Swedish biopharma firm XSpray Pharma and other companies that were challenging two patents for dasitinib listed in the FDA's Orange Book, set to expire in 2025 and 2026. A settlement with XSpray was reached last year, allowing XSpray to potentially launch a generic version, Dasynoc, as early as September 1, 2024. The FDA is expected to make a decision on Dasynoc by July 31.

The introduction of Dasynoc is part of a larger trend, as the FDA has already approved several new generics this year, including multiple cancer drugs. This influx is likely to drive down prices in oncology, per IDP Analytics. Sprycel’s current list price exceeds $18,000 per month, and since CML predominantly affects adults over 65, the medication is often covered by Medicare.

Besides XSpray, other pharmaceutical giants such as Biocon and Teva Pharmaceutical have also developed dasitinib generics, receiving tentative FDA approval. However, the threat to Bristol Myers extends beyond Sprycel. Generic versions of Revlimid are already on the market to a limited extent, and key patents for Eliquis and Opdivo will expire in 2026 and 2028, respectively.

In response to these looming challenges, Bristol Myers is actively working on expanding its oncology portfolio. The company is focusing on Breyanzi, a CAR-T cell therapy for various types of lymphoma and leukemia, as well as Abecma for multiple myeloma. Opdualag, a combination immunotherapy for melanoma, is also a crucial part of their strategic plan.

Moreover, Bristol Myers' pipeline includes two early-stage candidates for acute myeloid leukemia (AML), a notoriously difficult-to-treat condition. The company also collaborates with Servier to market Idhifa for AML.

While the patent cliff poses a significant threat, Bristol Myers is taking steps to mitigate the impact through innovation and strategic expansion in oncology. The company's efforts to diversify its portfolio and develop new treatments reflect its strategy to maintain its competitive edge in a challenging market landscape.