Lupin of India has become the first company to score approval in the U.S. for its generic version of Boehringer Ingelheim’s blockbuster COPD treatment Spiriva HandiHaler.
The FDA has signed off on Lupin’s generic 18 mgc/capsule a month after the company gained the same endorsement from Health Canada.
Lupin said it will produce the copycat at its plant in Pithampur, India. But that could be a problem as the facility has been plagued by inspection snafus. As recently as March of this year, the company reported in a regulatory filing that the FDA cited 10 violations at the plant in a Form 483.
The approval is the first in the U.S. for a dry powder inhaler from India, according to Lupin CEO Vinita Gupta. With the news, the price of Lupin’s shares jumped by 5% on Wednesday.
“This is an important milestone in our journey of building our respiratory franchise globally,” she said.
Tiotropium bromide inhalation powder is for long-term, once-daily maintenance for patients with COPD, including chronic bronchitis and/or emphysema. It also treats bouts with wheezing, coughing and shortness of breath.
Boehringer has had nearly two decades of exclusivity in the U.S. for Spiriva HandiHaler, which was approved by the FDA in 2004 as a COPD maintenance therapy and five years later for COPD exacerbations.
Another type of inhaler from BI, Spiriva Respimat—which delivers a mist instead of dry powder—was endorsed by the FDA for COPD in 2014 and a year later for asthma.
Worldwide sales of Spiriva exceeded $5 billion in 2015, but competition in a market full of formidable foes—including GSK’s Advair, Roche’s Xolair, AstraZeneca’s Symbicort and Mylan’s EpiPen—took its toll.
Spiriva took another sales slide as it began to face generic competition in Europe in 2021. It still recorded (PDF) sales of $1.7 billion last year, with $1.3 billion coming in the U.S. It was an overall decrease of 12% from sales of 2021.
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In the U.S., Boehringer Ingelheim holds patents on Spiriva until 2027, according to the FDA's Orange Book database. It isn't immediately clear whether those will preclude Lupin from launching its copycat product.