European Medicines Agency Approves Transfer of Marketing Authorization and Renewal of EPAR for Esbriet
Reshaping the Landscape of Idiopathic Pulmonary Fibrosis Treatment
Esbriet (active ingredient: pirfenidone) was a leading idiopathic pulmonary fibrosis (IPF) treatment developed by Roche. However, with patent expiration and the rise of generic competitors like Viatris, sales began to decline sharply. Roche decided to streamline its portfolio and divest Esbriet to focus research and development resources on high-growth, new pipeline assets. As a result, the marketing rights for all markets outside the United States were transferred to H.A.C. Pharma of France, and the U.S. marketing rights were transferred to Legacy Pharma.
Regulatory Procedures Following the Transfer of Marketing Authorization
The European Medicines Agency (EMA)'s recent update to the European Public Assessment Report (EPAR) is the official procedure that occurred following the transfer of the marketing authorization (MAH) from Roche to H.A.C. Pharma. This is not a renewal due to issues with the product's quality or clinical efficacy and safety profile, but rather a routine administrative approval following a business transfer. With the regulatory agency's final approval of this transfer, Esbriet can continue to be legally sold in the 27 countries of the European Union without interruption. This ensures that patients and healthcare professionals can continue to access the treatment without interruption.
Strategic Value of a Mature Asset in the Face of Intensifying Generic Competition
Esbriet's global sales in 2024 fell to approximately $54 million (approximately CHF 50 million) due to the impact of generic penetration, a decrease of about 56% compared to the previous year. In contrast, Boehringer Ingelheim's competing drug, Ofev (active ingredient: nintedanib), dominates a market of approximately $3.8 billion in 2025, based on expanded indications and market share. For Roche, a large corporation, Esbriet is no longer an attractive growth driver, but for H.A.C. Pharma, a small to medium-sized specialty pharmaceutical company, it can serve as a stable cash cow. Leveraging brand recognition and accumulated clinical data, H.A.C. Pharma is expected to develop a strategy to defend a certain level of niche market share in the face of price competition from generic drugs.
Long-Term Outlook and Implications for the Idiopathic Pulmonary Fibrosis Market
The global idiopathic pulmonary fibrosis treatment market, centered on nintedanib and pirfenidone, is expected to grow to approximately $7.6 billion by 2034, driven by an increase in the number of patients and improved diagnosis rates. With the expiration of Ofev's patent and the entry of various generic developers such as Dexcel Pharma, market price pressure will intensify. H.A.C. Pharma will focus on reorganizing its supply chain in the European market and securing a stable distribution network, using this EMA EPAR approval as a stepping stone. Ultimately, this will be a prime example of how the spin-off of a mature bioasset can lead to efficient market diversification and improved patient benefits.
The transfer of Esbriet's marketing authorization in Europe and the renewal of its EPAR demonstrate a typical portfolio diversification strategy in which a blockbuster asset with expired patents is transferred to a small, specialized pharmaceutical company to extend its market life. Although Esbriet's sales have declined to $54 million in 2024, H.A.C. Pharma will aim to maintain its niche market share in the European idiopathic pulmonary fibrosis market by leveraging its existing extensive clinical data and brand recognition. In the short term, this will ensure that patients continue to receive treatment without supply chain disruptions, and in the medium to long term, the price competition between pirfenidone generics and Boehringer Ingelheim's Ofev in the $3.8 billion market is expected to intensify. This transaction provides large pharmaceutical companies with opportunities to focus resources and provides the acquiring company with immediate revenue generation and a platform to strengthen its European distribution network, making it a strategic milestone for both companies.
Source: EMA (ema)