Drug Approval
Cipla strengthens US respiratory portfolio with final FDA nod for generic Nintedanib
ANDA approval for 100 mg and 150 mg capsules targeting idiopathic pulmonary fibrosis opens access to a $3.76 billion market in USA
- By IPP Bureau
| April 04, 2026
Cipla USA, the wholly owned US subsidiary of Indian pharma giant Cipla Limited, has announced that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, 100 mg and 150 mg, indicated for treatment of Idiopathic Pulmonary Fibrosis (IPF).
The generic capsules are the therapeutic equivalent of Ofev, marketed by Boehringer Ingelheim, a cornerstone therapy for the chronic, progressive lung disease marked by irreversible lung scarring, declining function, and a significant toll on patients’ quality of life.
“This approval strengthens our respiratory franchise and reflects our continued commitment to delivering high–quality therapies to patients. We are well prepared with a robust supply plan to support a successful launch,” said Marc Falkin, CEO of Cipla North America.
Cipla’s Nintedanib Capsules will be made available through specialty pharmacy distribution channels, aiming to provide reliable access to a market where Ofev generated approximately $3.76 billion in US sales, according to IQVIA.
The approval marks a major expansion of Cipla’s presence in the US respiratory space and underscores its push to bring high-quality, affordable treatment options to patients with serious lung conditions.
