Sandoz Launches First Generic Esbriet (Pirfenidone) in the U.S. for Idiopathic Pulmonary Fibrosis

Compiled by | Li Tom

Sandoz Launches First Esbriet Generic in the U.S. for Idiopathic Pulmonary Fibrosis (IPF) TreatmentRecently, Sandoz officially announced the launch of the first Esbriet generic in the United States, indicated for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This prescription oral generic drug is now immediately available to patients through pharmacies across the U.S., and eligible patients can participate in a $0 co-pay program.

Idiopathic Pulmonary Fibrosis (IPF) is a progressive and rare disease that currently has no cure. It causes irreversible lung scarring in patients, leading to breathing difficulties. IPF primarily affects adults over the age of 50 and is more common in men, with approximately 140,000 Americans diagnosed with IPF. In terms of treatment, besides medications that can slow the formation of scar tissue, patients are usually advised to maintain moderate exercise, a healthy diet, and adhere to prescribed oxygen therapy.

Just two months ago, a federal judge in Delaware dismissed a patent infringement lawsuit filed by Genentech, a subsidiary of Roche. In this case, Genentech argued that the generic drugs of Sandoz and other pharmaceutical manufacturers infringed up to six patents of Esbriet. (For more details, please click on "Roche's Genentech Esbriet Patent Lawsuit Dismissed")

However, Judge Andrews, who was responsible for hearing the case, ultimately ruled that Sandoz did not commit any infringement. He stated that Sandoz did not instruct doctors to violate Genentech's claimed dose adjustment rights in its label, and the dose adjustment steps in Sandoz’s label were broader than the scope covered by Genentech’s claimed patent. The current evidence also fails to prove that Sandoz's proposed label allegedly encouraged or promoted doctors to engage in the so-called infringing behavior.

Publicly available data shows that Esbriet achieved sales of $1.04 billion in 2021, with approximately $732 million coming from the U.S. market, representing a 4% decline from the previous year. In 2021, the drug's biggest competitor, Boehringer Ingelheim's Ofev, generated $2.58 billion in global sales, reflecting a 25% growth in sales at constant exchange rates. By comparison, Ofev has broader indications, covering other types of interstitial lung diseases.

In addition, both Roche and Boehringer Ingelheim are developing next-generation IPF therapies. For instance, Roche has a recombinant human pentraxin 2 protein in a Phase 3 study, while Boehringer Ingelheim is investigating a PDE4B inhibitor, BI1015550, with plans to enter Phase 3 research this summer.

Notably, for many years, the U.S. generic drug industry has been under pricing pressure. Although Novartis successfully launched the generic version of Esbriet, it has not been immune to the impact. In the first quarter, Sandoz's sales in the U.S. market dropped by 2%, while, by comparison, its sales in the European market increased by 9% in constant currency terms.

Currently, Novartis is considering reorganizing Sandoz to make it a relatively independent unit and has initiated a strategic review to decide whether it should spin off its generics business. At the investor conference call last month, Novartis CEO Vas Narasimhan stated that the company expects Sandoz’s oral solid dosage business in the U.S. market to reach its lowest point this year and early next year.

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Sandoz launches first generic pirfenidone in US for patients with idiopathic pulmonary fibrosis, growing its respiratory portfolio