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Cipla Expands U.S. Respiratory Portfolio with Approval of Nintedanib Capsules (100mg & 150mg) for Idiopat
The generic nintedanib capsules will be distributed through U.S. pharmacy channels, with Ofev generating about $3.76 billion in U.S. sales, the company said.
On Friday, April 3, 2026, Cipla USA Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Nintedanib Capsules in 100 mg and 150 mg doses.
These capsules serve as a generic therapeutic equivalent to Ofev, marketed by Boehringer Ingelheim, for Idiopathic Pulmonary Fibrosis, a chronic, progressive lung disease characterized by irreversible lung tissue scarring.
According to IQVIA data from January 2026, Ofev generated approximately $3.76 billion in U.S. sales, underscoring significant market demand for reliable, high-quality treatment options in this category.
Cipla is set to launch the treatment on an immediate basis. CEO Marc Falkin of Cipla North America said, "This approval strengthens our respiratory franchise," reflecting the company's commitment to delivering high-quality therapies.
Operating 46 manufacturing sites globally, Cipla is ranked 3rd largest by prescription in the U.S. generic market, with strategic focus on India, South Africa, and North America.