Cipla gains US FDA nod for Ventolin; analysts see $100 mn sales potential

Cipla has received the US FDA's approval for generic Ventolin inhaler. Analysts see $100-million sales potential from the drug, which could aid US business outlook

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  Indian pharmaceutical company Cipla has received final approval from the United States Food and Drug Administration (US FDA) to launch generic therapeutic equivalent of Ventolin, an albuterol inhaler. 

 

The nod, analysts said, would address concerns around the company’s US growth, which had been under pressure since the discontinuation of Lanreotide, and loss of exclusivity in gRevlimid.

 

The approval will also aid revenue shortfall over the coming years, improving the stock’s outlook, they added.

 

Analysts at ICICI Securities have upgraded the stock to ‘Buy’ from ‘Add’, raising the target price to ₹1,550 (from ₹1,4500).

 

 

“The company’s strong pipeline of eight respiratory drugs (including gAdvair, gSymbicort, gQvar) and peptide assets (gVictoza) should help Cipla overcome the sales impact of gRevlimid, while the supply scenario of Lanreotide may improve in H1FY27,” they noted.

 

The brokerage believes recent approvals are likely to strengthen Cipla’s US business and aid meaningful upside in the near term. “We raise our FY27-28 earnings per share (EPS) estimates by 1-2 per cent to factor in the benefits of the new launches in US and INR’s depreciation,” they said.  CHECK Stock Market LIVE Updates

 

Cipla’s US biz gets regulatory boost

On Thursday, Cipla said its wholly-owned subsidiary in the USA, Cipla USA Inc, has received final nod for its generic version of the popular asthma inhaler, Ventolin HFA (Albuterol Sulfate).

 

An Albuterol Sulfate Inhaler (90 mcg) is used to treat or prevent bronchospasms. This is the first "AB-rated" generic equivalent to Ventolin, and is expected to be launched in H1 of FY 2026-27 in the United States of America. 

 

Analysts noted that Ventolin HFA has a market size of around $1.5 billion, with estimated annual sales potential of ~$100 million amid limited competition.

 

The approval is expected to strengthen Cipla’s US respiratory franchise, a key focus area with high entry barriers in complex inhalation products, and aligns with its strategy of expanding in margin-accretive complex generics.

 

“This development builds on Cipla’s earlier success after it received US FDA’s approval for the first AB-rated generic of Proventil HFA in FY21. It marked the company’s entry into the US device-based inhalation segment,” Motilal Oswal Financial Services noted.

 

Since then, Cipla has scaled up strongly, supplying over 50 million inhaler units in the US, increasing its market share in the albuterol MDI segment from approximately 13 per cent (FY24) to ~18 per cent (FY25) and further to ~22 per cent (as of December 2025).

 

“The company’s proven track record in scaling up its earlier Albuterol launch indicates that the latest approval is also likely to see effective commercialisation and meaningful medium-term contribution,” MOFSL said with a ‘Neutral’ rating and a target price of ₹1,307.

 

Notably, Ventolin HFA is one of the most established short-acting beta agonist (SABA) inhalers globally, generating ~$2.6 billion in cumulative revenue over the past five years, supported by its strong brand recall, wide prescription base, and long clinical track record.

 

Analysts think Cipla is “strategically positioned” with generics for both Ventolin and Proventil, strengthening its presence across key albuterol inhaler segments.

 

These approvals, they said, enhance Cipla’s ability to capture a broader share of the US albuterol inhaler market across molecules and device profiles, supporting sustainable growth in its respiratory portfolio.

 

Additionally, Cipla USA Inc. Has also received final approval from the US FDA for Nintedanib Capsules (100 mg and 150 mg) used for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a generic equivalent of Ofev.

 

As per IQVIA, MAT January 2026, Ofev generated US sales worth approximately $3.76 billion.

 

ICICI Securities expects gVentolin (90mg) and gOfev (100mg and 150mg) to likely generate sales of $100 million annually.

 

“Cipla’s strong US respiratory drug pipeline, along with multiple peptide launches targeted in the next 6-12 months, could lift US sales to $880 million in FY27. Momentum is likely to be stronger in FY28 as lanreotide supplies improve and it launches gSymbicort towards end-FY27,” the brokerage said. 

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India business momentum remains robust

Cipla’s strong India business -- spread across branded, trade generics and consumer wellness -- is likely to account for 44 per cent (₹12,600 crore) of its overall sales in FY26. 

 

ICICI Securities expects the India business to register a CAGR of 8.9 per cent over FY26-28.

 

“We expect Cipla to deliver a revenue CAGR of 10.3 per cent and Ebitda CAGR of 12.9 per cent over FY25-28,” it said.    ============  Disclaimer: Views and outlook shared belong to the respective brokerages and analysts and are not endorsed by Business Standard. Readers are advised to exercise discretion.