Lupin wins first FDA approval for generic of Boehringer blockbuster Spiriva

Indian drugmaker Lupin today said it won FDA approval for the first generic version of Spiriva, a blockbuster COPD drug from Boehringer Ingelheim.

The generic, known as tiotropium bromide inhalation powder, first won approval as a brand name product in 2004 as a maintenance treatment for COPD-related breathing problems, before expanding its label five years later to reduce COPD exacerbations.

Spiriva — sold in a capsule form and delivered via an inhaler system — made Boehringer Ingelheim $1.7 billion last year, according to its annual report.

Vinita Gupta

“This is an important milestone in our journey of building our respiratory franchise globally,” said Lupin CEO Vinita Gupta in a statement. The approval comes roughly a month after Health Canada granted approval to the generic.

Further details on the timing of the launch of the generic remain undisclosed. The company did not immediately respond to an inquiry.

A Boehringer Ingelheim spokesperson told Endpoints that the company is aware of Lupin’s FDA approval for the generic, adding that the approval “does not guarantee launch of generic tiotropium HandiHaler and does not impact or limit the availability or support of Spiriva HandiHaler.”

FDA shut down Boehringer’s attempt to block the generic last week, partially granting and partially denying a 2012 citizen petition. That petition asked the regulatory agency to not approve any ANDA referencing Spiriva or any Boehringer oral inhaler product that contains tiotropium bromide — unless certain requirements had been met related to bioequivalence and labeling.

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Lupin said that the generic will be made at its manufacturing site in Pithampur, India. That same facility was recently under FDA scrutiny: a 13-page Form 483 detailed the facility’s failure to document malfunctions and breakdowns that took place during both manufacturing and packaging.

Out of 1,759 “breakdown notifications” between Jan. 2019 and March 2023, Lupin only investigated 48 of those notifications, says the report. Lupin said in a letter to the National Stock Exchange of India, “We are addressing the observations comprehensively and will work with the U.S. FDA to resolve these issues at the earliest.”

The plant, which started operations back in 2007 and has more than 1,500 employees, makes oral contraceptive APIs, formulations of dermatological and inhalation products, among others.

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