The company had originally guided for a launch in H2 FY23, nearly four fiscal years ago, but regulatory setbacks, including a warning letter at its Pithampur facility, derailed the timeline.
Cipla eventually shifted manufacturing and the filing for this complex dry powder inhaler to its US manufacturing site, which has now secured the approval. The street was sceptical of the opportunity diluting, but in fact it may actually be bigger today.
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The US Advair market is now estimated at $900 million, well above earlier expectations of $500-550 million. Competition remains limited to players such as Teva, Mylan, Hikma and Aurobindo’s Respirent, leaving room for Cipla to capture a 12-18% market share, supported by its respiratory franchise and expertise in complex inhalation products.
Nuvama estimates the product could generate $60 million in annual revenue, with the potential for a 1% EPS upgrade. What also makes this approval noteworthy is where it comes from.
The approval is for Cipla’s US manufacturing facility—a significant positive at a time when US-based production is gaining strategic importance amid the Trump administration’s tariff push and increasing scrutiny of overseas generic drug manufacturing.
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Sometimes, a delayed launch isn’t a missed opportunity. It arrives just as the market—and the geopolitical landscape—becomes more favourable.
Shares of Cipla Ltd ended at ₹1,444.65, up by ₹34.80, or 2.47%, on the BSE.
(Edited by : Jomy Jos Pullokaran)
First Published: Jul 28, 2026 3:45 PM IST
