Glenmark gets USFDA nod for generic fluticasone propionate nasal spray

In August 2026, Glenmark Pharmaceuticals Limited recently received U.S. FDA approval for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray, further expanding its respiratory medicine portfolio in the United States. The approved nasal spray is bioequivalent and therapeutically equivalent to Flonase Nasal Spray, 0.05 mg/spray, the reference listed drug marketed by Haleon US Holdings LLC under NDA 020121.

The approval also gave Glenmark access to an established U.S. nasal spray market. According to IQVIA sales data for the 12 months ending June 2026, Flonase Nasal Spray recorded annual sales of approximately $295.2 million in the United States. Therefore, the approval provides Glenmark with an opportunity to strengthen its presence in the U.S. respiratory segment and expand access to an established treatment option.

This latest U.S. FDA approval further strengthens Glenmark’s respiratory product portfolio and supports its broader strategy of expanding affordable pharmaceutical options in key international markets. As per the press release, with the Fluticasone Propionate Nasal Spray now approved for the U.S. market, Glenmark continues to build its presence in respiratory healthcare while leveraging its portfolio of differentiated and accessible pharmaceutical products.

Impact on the Chemical Market

Nasal sprays are the most popular form of medication and can efficiently deliver the drug directly into the nasal cavity. Nasal sprays deliver medication or saline directly into the nasal cavity to treat various conditions like congestion, allergies, sinus infections, and cold symptoms by clearing mucus, reducing inflammation, and shrinking swollen blood vessels.

Nasal sprays are broadly classified into several categories based on their primary active ingredient and mechanism of action. Each category has different indications and precautions, such as steroid nasal sprays, topical decongestant nasal sprays, antihistamine nasal sprays, and saline nasal sprays.

Impact on the Nasal Sprays Market

The global nasal sprays market size accounted for USD 6.50 billion in 2025 and is predicted to increase from USD 6.99 billion in 2026 to approximately USD 13.52 billion by 2035, expanding at a CAGR of 7.60% from 2026 to 2035.

According to Precedence Research, the market is experiencing unprecedented growth, driven by rising healthcare spending, strong demand for targeted, fast-acting, and non-invasive medications, and rising cases of allergies and sinus infections. The increasing incidence of respiratory conditions such as allergic rhinitis, asthma, and chronic sinusitis is driving the market's growth. The surge in the older population and increasing demand for affordable generic nasal sprays are bolstering the market's growth. The rapid urbanization and rising pollution are likely to spur the demand for fast-acting nasal decongestants and steroid sprays.

The increasing need for non-invasive drug delivery methods is also projected to create several opportunities in the nasal sprays market. Nasal sprays provide a rapid therapeutic effect by targeting the highly vascularized nasal mucosa. Nasal sprays are increasingly becoming popular for administering systemic drugs like vaccines and CNS treatments. They bypass first-pass metabolism and offer a non-invasive alternative to injections.

Impact on the Inhalation and Nasal Spray Generic Drugs Market

The global inhalation and nasal spray generic drugs market size is projected to surpass around USD 54.44 billion by 2034 from USD 23.06 billion in 2024, at a CAGR of 8.97% between 2025 and 2035.

According to Precedence Research, the increasing cases of breathing-related issues or diseases in the population due to various genetic and environmental conditions, and allergies that result in the number of diseases such as asthma and chronic obstructive pulmonary disease (COPD), drive the growth of the market. The rising prevalence of asthma, COPD, and other instant breathing-related diseases drives the demand for treatment medication, which drives the demand for the inhalation and nasal spray generic drugs market.

The rising government investment and public and private market investment in the development and launch of the drugs, and the major pharmaceutical firms investing in innovation in the treatment and medication of respiratory diseases are further helping in fueling the growth of the market. The increasing government initiatives and supporting regulations in the development of the healthcare and pharmaceutical sector are driving the opportunity in the growth of the inhalation and nasal spray generic drugs market.

Expert Opinion

Marc Kikuchi, President and Business Head, North America, Glenmark, said the approval represents another step in expanding the company’s U.S. respiratory portfolio. He added that the company has established a strong foundation in the therapeutic area and remains focused on broadening access to quality and affordable treatment options that address the evolving needs of patients and healthcare providers.