Novartis Sandoz Launches First Esbriet Generic in US

A few days ago, Sandoz officially announced the launch of the first generic version of Esbriet in the United States for the treatment of patients with idiopathic pulmonary fibrosis (IPF). The prescription oral generic is already available immediately to patients through pharmacies across the U.S., and eligible patients can participate in a $0 copay plan.

Idiopathic pulmonary fibrosis is a rare progressive disease with no cure that causes irreversible scarring of the lungs and makes breathing difficult. IPF primarily affects adults over the age of 50 and is more common in men, with approximately 140,000 Americans living with IPF. In addition to medications that slow the formation of scar tissue, patients are usually advised to maintain moderate exercise, eat a good diet, and use oxygen therapy as prescribed.

Just two months ago, a federal judge in Delaware rejected a patent infringement lawsuit brought by Roche subsidiary Genentech. In the case, Genentech argued that generic drugs from Sandoz and other drugmakers infringed on as many as six of Esbriet's patents. (For more details, please click "Roche Genentech Esbriet Patent Lawsuit Rejected")

However, Judge Andrews, who heard the case, ultimately found that Sandoz did not constitute any infringement, saying that Sandoz did not require doctors in its label to violate Genentech's claimed rights to dosing and that Sandoz's labeling The dosage modification steps are broader than Genentech's claimed patent coverage, and the current evidence fails to establish that Sandoz's suggested labelling allegedly encouraged or promoted physicians to engage in purported infringing practices.

According to public information, Esbriet achieved sales of $1.04 billion in 2021, of which about $732 million came from the U.S. market, down 4% from the previous year. Boehringer Ingelheim Ofev, the drug's biggest rival, generated $2.58 billion in global sales in 2021, a 25% increase in sales at constant exchange rates. In contrast, Ofev has a broader indication and involves other types of interstitial lung disease.

In addition, both Roche and Boehringer Ingelheim are developing next-generation treatments for IPF. For example, Roche has recombinant human pentraxin 2 protein in a Phase 3 study, and Boehringer Ingelheim is working on a PDE4B inhibitor, BI1015550, with a Phase 3 study planned for this summer.

It is worth noting that the U.S. generic drug industry has been under pricing pressure for many years. Although Novartis successfully launched the Esbriet generic drug, it is inevitably unaffected. In the first quarter, Sandoz's U.S. sales fell 2 percent, compared with a 9 percent increase in European sales in constant currency.

Novartis is now considering restructuring Sandoz into a relatively autonomous unit and launching a strategic review to decide whether it should be split into a generics business. On an investor call last month, Novartis Chief Executive Vas Narasimhan said the company expects Sandoz's oral solid drug business in the U.S. market to reach its lowest level this year and early next year.