Lupin Limited announced the launch of Azilsartan Medoxomil Tablets, 40mg and 80mg, in the United States on June 17, 2026. The product is indicated for the treatment of hypertension in adults to lower blood pressure and is bioequivalent to Edarbi® of Azurity Pharmaceuticals, Inc. Lupin is the exclusive first-to-file for this product, making it eligible for 180-day generic drug exclusivity. This exclusivity period allows the company to capitalize on the market before other generic competitors enter. Azilsartan Medoxomil Tablets had estimated annual sales of USD 53.5 million in the U.S., according to IQVIA MAT April 2026 data.

Market and Product Details

The introduction of this product strengthens Lupin's portfolio in the cardiovascular therapy area. The company holds a strong position in the U.S. market across multiple segments, including respiratory, anti-diabetic, and anti-infective therapies. Additionally, Lupin maintains a presence in gastrointestinal, central nervous system, and women's health sectors.

Company Overview

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin operates 15 manufacturing sites and 7 research centers globally, supported by a workforce of over 24,000 professionals. The company is also committed to improving patient health outcomes through its subsidiaries — Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Lupin Limited has announced a strategic collaboration with LABORATORIOS ERN S.A. for the launch of Luforbec® (beclometasone/formoterol) 100/6 in Spain. This fixed dose combination, delivered via a pressurized metered dose inhaler (pMDI), is intended for the regular treatment of adult asthma and chronic obstructive pulmonary disease (COPD). The partnership leverages Lupin's global respiratory expertise and ERN's established national reach to enhance access to quality respiratory care for patients across Spain.

Partnership Overview

The collaboration targets the Spanish market, aiming to address the therapeutic needs of adults managing asthma and COPD. By combining Lupin's manufacturing capabilities with ERN's local distribution network, the alliance seeks to deliver proven respiratory therapies to a broader patient population.

Strategic Significance

Thierry Volle, President EMEA and Emerging Markets at Lupin, highlighted that the launch in Spain follows successful introductions in the UK and Germany. He emphasized that this milestone reinforces the company's commitment to advancing global access to quality respiratory care. David Solanes, CEO of LABORATORIOS ERN, S.A., noted that the partnership allows the introduction of a high-value therapy to Spanish patients and represents an expansion into a new therapeutic area for ERN.

Product Indications

Luforbec® is indicated for the regular treatment of asthma where a combination of inhaled corticosteroid and long-acting beta2-agonist (ICS/LABA) is appropriate. This includes patients not adequately controlled with ICS and 'as needed' inhaled short-acting beta2-agonist, or those already controlled on both ICS and LABA. Additionally, it is indicated for the symptomatic treatment of severe COPD (FEV1 < 50% predicted normal) in patients with a history of repeated exacerbations who have significant symptoms despite regular therapy with long-acting bronchodilators.