Amphastar Receives FDA Approval for Ipratropium Bromide Inhalation Aerosol
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Should l Buy AMPH?
Amphastar announced that the FDA has approved the company's abbreviated new drug application, or ANDA, for Ipratropium Bromide HFA Inhalation Aerosol 17mcg/actuation. The FDA determined that Amphastar's Ipratropium Bromide HFA Inhalation Aerosol is bioequivalent and therapeutically equivalent to Boehringer Ingelheim's Atrovent HFA Inhalation Aerosol. Additionally, the FDA has confirmed that this product is eligible for 180-days of generic drug exclusivity for Ipratropium Bromide HFA Inhalation Aerosol as we were the first ANDA applicant with Paragraph IV certification. This exclusivity period will begin on the first day that Amphastar's Ipratropium Bromide HFA Inhalation Aerosol is commercially launched.
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Analyst Views on AMPH
Wall Street analysts forecast AMPH stock price to rise
4 Analyst Rating
2 Buy
2 Hold
0 Sell
Moderate Buy
Current: 26.490
Low
30.00
Averages
32.00
High
34.00
Current: 26.490
Low
30.00
Averages
32.00
High
34.00
About AMPH
Amphastar Pharmaceuticals, Inc. is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling generic and proprietary injectable, inhalation, and intranasal products. Additionally, it sells insulin API products. Most of its finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. The Company manufactures and sells over 25 products, such as BAQSIMI (glucagon) nasal powder 3mg, Primatene MIST, Glucagon for Injection Emergency Kit, Enoxaparin, Naloxone and Other Marketed Products, including Cortrosyn (cosyntropin for injection), Amphadase, Epinephrine injection, Lidocaine jelly, Lidocaine topical solution, Phytonadione injection, and others. The Company manufactures and sells two API products, Recombinant Human Insulin (RHI API) and porcine insulin API, for the injectable insulin market.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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See More
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- Conference Call Details: The company will hold a conference call at 2:00 PM Pacific Time to discuss the financial results, with investors able to participate by dialing 877-407-0989 (international calls at 201-389-0921), reflecting the company's commitment to transparency and investor communication.
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See More
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See More
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- Earnings Miss: The company posted earnings per share of $1.74, missing the consensus estimate of $1.99, reflecting pressures from rising costs and intensified market competition, which may raise concerns about future profitability among investors.
- Significant Stock Decline: In pre-market trading, Flutter's shares plummeted by 14.8% to $104.84, indicating a strong market reaction to the disappointing earnings report, which could adversely affect the company's short-term market performance.
- Uncertain Future Guidance: Flutter issued weak FY26 revenue guidance in its report, potentially diminishing market confidence in the company's growth prospects and exacerbating stock volatility risks.
See More
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- Strong Sales Performance: The company achieved quarterly sales of $134.274 million, surpassing the analyst consensus estimate of $134.120 million, suggesting that its products continue to gain competitive traction in the market, potentially driving future revenue growth.
- Stock Surge: Following the earnings report, Applied Optoelectronics shares jumped 20.4% to $64.69 in pre-market trading, reflecting market optimism about the company's future performance and likely attracting more investor interest.
- Positive Guidance: The company issued first-quarter sales guidance above market expectations, further solidifying its market position in the optoelectronics sector and indicating stable growth potential for the upcoming quarters.
See More
Amphastar Pharmaceuticals Q4 2025 Earnings Call Insights
- FDA Approval: Amphastar Pharmaceuticals received FDA approval for ipratropium bromide HFA inhalation aerosol, which is expected to drive near-term growth and comes with 180 days of generic exclusivity, highlighting the company's strong momentum in new product development.
- Sales Performance Review: The company reported net revenues of $183.1 million for Q4 2025, a 2% decline year-over-year, yet BAQSIMI's 12% sales growth indicates strong market demand in specific product lines, suggesting potential for overall performance improvement through new launches.
- Future Outlook: For 2026, mid-single-digit unit growth is expected in the U.S., although international volumes will decline due to exiting unprofitable markets, with overall revenue growth anticipated in the mid to high-single-digit range, reflecting a cautious optimism about future prospects.
- Increased R&D Investment: R&D expenditures rose 29% to $23.3 million in Q4, demonstrating the company's ongoing commitment to innovation and high-value product development, aimed at enhancing its competitive position and long-term growth potential.
See More
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- FDA Approval: Amphastar Pharmaceuticals' Ipratropium Bromide HFA Inhalation Aerosol has received FDA approval, marking a significant achievement in the complex high-value generics sector, and is expected to enhance the company's respiratory product portfolio significantly.
- Market Exclusivity: As the first ANDA applicant with Paragraph IV certification, this product is eligible for 180 days of generic drug exclusivity, which is anticipated to provide substantial market share and revenue growth for the company.
- Significant Market Potential: According to IQVIA data, Atrovent®HFA had U.S. sales of approximately $112 million for the year ending December 31, 2025, positioning Amphastar's product to capture a significant share of this market.
- Strengthened R&D Strategy: Amphastar is also developing multiple proprietary products, including injectable and intranasal forms, further solidifying its market position and long-term growth strategy in the biopharmaceutical sector.
See More
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- Earnings Release Schedule: Amphastar Pharmaceuticals will announce its fourth quarter 2025 results after market close on February 26, 2026, which is expected to provide critical financial data for assessing the company's performance.
- Conference Call Details: The company will hold a conference call at 2:00 PM Pacific Time to discuss the financial results, with investors able to participate by dialing 877-407-0989 (international calls at 201-389-0921), reflecting the company's commitment to transparency and investor communication.
- Webcast Replay Availability: A replay of the earnings call will be accessible on the company's website within 24 hours after the live event, enhancing investor access to information and insights.
- Company Background Information: Amphastar Pharmaceuticals focuses on developing and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products primarily used in hospital and urgent care settings, showcasing its expertise and market positioning in the biopharmaceutical sector.
See More
Amphastar's Floyd Petersen Sells 16,679 Shares for $441,836
- Executive Transaction: Floyd Petersen of Amphastar Pharmaceuticals exercised 16,679 stock options and immediately sold all shares for approximately $441,836, indicating a potential lack of confidence in the stock's future performance.
- Ownership Change: Following the sale, Petersen retains 75,531 shares valued at around $2 million, reflecting a 4% reduction in his holdings since May 2024, which may suggest a cautious outlook on market conditions.
- Market Performance: On the transaction date, Amphastar's stock had declined by 42% over the year, contrasting sharply with the S&P 500's 14% total return, highlighting the company's relative underperformance in the market.
- Share Buyback Program: Since 2016, Amphastar has repurchased over 14.1 million shares for approximately $369.1 million, demonstrating a proactive capital management strategy aimed at enhancing shareholder value amidst market challenges.
See More
