Lupin launches Nasal Spray in US market
By Shishta Dutta | Updated at: Oct 13, 2025 05:33 PM IST
Mumbai, July 4, 2025 – With the commercial launch of Ipratropium Bromide Nasal Solution in both 0.03% and 0.06% strengths, Lupin Ltd (NSE: LUPIN, BSE: 500257) has expanded its respiratory-focused portfolio in the United States. These strengths are generic equivalents to Boehringer Ingelheim’s Atrovent® Nasal Spray. Both the 0.03% formulation, which targets allergic and non-allergic perennial rhinitis in adults and children aged six and above, and the 0.06% variant, which is indicated for relief from runny nose caused by the common cold or seasonal allergic rhinitis in those aged five and older, have been approved for the purpose of providing symptomatic relief due to rhinorrhea.
Based on the statistics provided by IQVIA MAT in May 2025, the branded Atrovent® nasal spray is estimated to generate roughly USD 63 million in yearly sales in the United States. This launch comes after Lupin received permission from the United States Food and Drug Administration (FDA) in February 2025 for the 0.03% formulation and prior approval for the 0.06% strength. Both ANDA certifications allow for a smooth introduction into the market.
Market Impact
According to IQVIA MAT (May 2025), the reference listed drug (RLD) Atrovent® registered annual sales of approximately USD 63 million in the U.S., positioning Lupin to tap into a lucrative respiratory segment amid growing demand for allergy and cold relief formulations.
| Product Strength | Indication | Age Group |
|---|---|---|
| 0.03% | Allergic & nonallergic perennial rhinitis | Adults & children ≥6 |
| 0.06% | Rhinorrhea due to common cold or seasonal allergic rhinitis | Adults & children ≥5 |
| Product Details | Data |
|---|---|
| Brand Reference | Atrovent® (Boehringer Ingelheim) |
| Annual US Market Size (IQVIA) | USD 63 million (as of May 2025) |
| Launch Region | United States |
| Therapeutic Focus | Respiratory / Allergy |
About Lupin
Lupin Limited is a Mumbai-headquartered global pharmaceutical company with a presence in over 100 markets. The company specializes in branded and generic formulations, biosimilars, and APIs. Its key therapy areas include respiratory, cardiovascular, anti-diabetic, and gastrointestinal. Lupin operates 15 manufacturing facilities and 7 R&D centers, supported by a workforce of over 23,000 professionals.
The company is also expanding its ecosystem through subsidiaries like Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
REF: https://nsearchives.nseindia.com/corporate/Lupin2_04072025150912_NSELetterwithPressRelease04072025.pdf
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