Lupin launches generic HandiHaler, receives FDA OK for 2 generics
Lupin is offering Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, for the treatment of chronic obstructive pulmonary disease.
Tiotropium Bromide Inhalation Powder, 18 mcg/capsule is a generic equivalent of Boehringer Ingelheim’s Spiriva HandiHaler.
With this launch, Lupin said it is introducing an alternative to combat COPD, a condition impacting more than 15 million adults in the United States and ranked as the fourth leading cause of death in the country. By extending enhanced accessibility to cutting-edge products, Lupin actively contributes to alleviating the burden of COPD for patients across the nation.
[Read more: Lupin obtains FDA OK for generic Doryx]
“We are delighted to announce the launch of generic Spiriva HandiHaler in the U.S., the first generic to this important drug for COPD," said Vinita Gupta, CEO of Lupin. "This launch is a testament to our commitment to advancing healthcare accessibility and is a result of years of hard work and dedication to building our complex products and respiratory franchise. Being the first to bring an FDA-approved generic version of Spiriva in the U.S. further reaffirms our commitment to enhancing the well-being of COPD patients for a healthier future.”
Tiotropium Bromide Inhalation Powder (Spiriva HandiHaler) had a market value of approximately $1.3 billion, according to IQVIA Mar 2023 data.
Lupin has received the Food and Drug Administration’s clearance for two generics.
[Read more: Lupin receives FDA OK for generic Banzel]
The company received approval for Metoprolol Succinate Extended-Release tablets, 25 mg, 50 mg, 100 mg, and 200 mg, which is the generic of Sequel Therapeutics’ Toprol-XL tablets. This product will be manufactured at Lupin’s Pithampur facility in India.
Metoprolol Succinate Extended-Release tablets (Toprol-XL) had a market value of roughly $305 million, per IQVIA June 2023 data.
Lupin also received FDA’s nod for Bromfenac Ophthalmic Solution, 0.09%, which is the generic of Bausch & Lomb’s Bromday. This product will be manufactured at Lupin’s Pithampur facility in India.
Bromfenac Ophthalmic Solution 0.09% (Bromday) had a market value of roughly $11 million, per IQVIA June 2023 data.