Company: TAK
Filing Date: 2025-06-25
Form Type: 20-F
Source: 0001395064-25-000095
Chunk: 9

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-06-25
Form: 20-F
Item: Item 3
Chunk 9
---
 various measures to control drug costs, including by encouraging medical practitioners to use and prescribe generic drugs, and in April 2023, announced that by the end of the fiscal year ending March 31, 2030, it aims to increase the ratio of Active Pharmaceutical Ingredients (APIs) with 80% or more of biosimilar replacement rates on a volume basis to at least 60% of all APIs that have biosimilar versions available. In addition, in March 2024, the government announced that it was extending its volume-based target of 80% in all prefectures (regions) for generic drug penetration with respect to products for which market exclusivity has expired, previously set in April 2021 with the deadline at the end of FY2023, as the main target until the end of fiscal year March 31, 2030. L egislation has also been passed in the U. S. and Europe encouraging the use of biosimilar products. Similar to generics, biosimilars aim to provide less expensive versions of innovative biologic products. Legislation has provided abbreviated pathways for the approval and marketing of biosimilar products, which may affect the profitability and commercial viability of our biologic products.

Certain products of ours have begun, or are expected over the next several years, to face declining sales due to the loss of patent protection or regulatory exclusivity. For example, following the expiration of patent protection covering the formulation of VELCADE and pediatric regulatory exclusivity, generic bortezomib products entered the market in 2022. Patent protection covering VYVANSE and the associated pediatric exclusivity expired in the U. S. in August 2023. While the effect has not been as strong as expected to date, we expect that sales of this product will be particularly affected in the fiscal year endingMarch 31, 2026 as a result of market erosion caused by the introduction of lower-priced generics. Furthermore, our current top selling product, ENTYVIO, will face loss of regulatory exclusivity in the latter half of this decade and certain patents covering various aspects of this product are expected to expire in 2032. See “ Item 4. Information on the Company - B. Business Overview - Intellectual Property” for details.

We may also be subject to competition from generic or biosimilar drug manufacturers prior to the expiration of patents if a manufacturer successfully challenges the validity of our patents, if a manufacturer is able to design around our patents, or if a manufacturer obtains approval of their product and launches it