Aurobindo Pharma gets USFDA approval for Beclomethasone HFA aerosol
- Aurobindo Pharma receives USFDA final approval for Beclomethasone HFA Inhalation Aerosol 40 mcg and 80 mcg on September 15, 2026
- This is the company's first metered-dose inhaler (MDI) product, a generic equivalent of Teva's QVAR®
- The product will be manufactured at the company's Raleigh, North Carolina facility owned by Aurolife Pharma LLC
- The US market for the approved product is estimated at $301 million for the twelve months ended July 2026
- Cumulative USFDA ANDA approvals for Aurobindo Pharma now stand at 596
*this image is generated using AI for illustrative purposes only.
Aurobindo Pharma received final approval from the US Food and Drug Administration (USFDA) on September 15, 2026, for Beclomethasone Dipropionate HFA Inhalation Aerosol in 40 mcg and 80 mcg strengths. This marks the company's first metered-dose inhaler (MDI) product.
The product is a generic equivalent of QVAR® Inhalation Aerosol, marketed by Teva Branded Pharmaceutical Products R&D LLC. It will be manufactured at Aurobindo Pharma's Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC.
Product and market details
The following table summarises the key details of the approved product and its market context:
| Parameter | Details |
|---|---|
| Product name | Beclomethasone Dipropionate HFA Inhalation Aerosol |
| Strengths | 40 mcg and 80 mcg |
| Approval type | USFDA final approval |
| Approval date | September 15, 2026 |
| Product category | Metered-dose inhaler (MDI) |
| Reference product | QVAR® Inhalation Aerosol (Teva) |
| Manufacturing site | Raleigh, North Carolina |
| US market size | $301 million |
| Launch status | Expected in upcoming quarters |
Significance of the MDI approval
Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. Its approval positions Aurobindo Pharma in a US market estimated at $301 million for the twelve months ended July 2026, according to IQVIA.
This is the company's first MDI product, representing an entry into the complex respiratory therapies segment of the US generics market. With this approval, Aurobindo Pharma's cumulative USFDA ANDA approvals stand at 596, comprising 571 final approvals and 25 tentative approvals.
What the Numbers Show
The addition of this product strengthens Aurobindo Pharma's portfolio of complex and differentiated products. The company now has 596 cumulative USFDA ANDA approvals, with this new MDI adding to its capabilities in the inhalation segment. The $301 million market size for the approved product and newer versions of the reference product indicates a significant revenue opportunity for the company's first foray into metered-dose inhalers.
Historical Stock Returns for Aurobindo Pharma
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -1.14% | +0.45% | +0.16% | +27.27% | +49.71% | 0.0% |
How might the entry of Aurobindo Pharma's generic Beclomethasone impact Teva's pricing strategy and market share for QVAR in the US?
What are the projected timelines and potential regulatory hurdles for Aurobindo to expand its MDI portfolio beyond this initial asthma product?
How does the $301 million market size compare to Aurobindo's existing revenue streams, and what percentage of their US generics revenue could this single product realistically capture?
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