Amphastar Announces FDA Approval for Ipratropium Bromide HFA

Rhea-AI Summary

Amphastar (NASDAQ:AMPH) announced FDA approval of its Ipratropium Bromide HFA Inhalation Aerosol 17mcg/actuation, found bioequivalent and therapeutically equivalent to Atrovent HFA. The FDA confirmed 180 days of generic exclusivity as the first Paragraph IV ANDA filer.

The company plans a commercial launch early in Q2 2026. IQVIA U.S. sales for Atrovent HFA were about $112 million for the 12 months ended December 31, 2025. Amphastar also disclosed multiple ANDA and biosimilar filings and development programs targeting markets worth billions.

Positive

• FDA approval for Ipratropium Bromide HFA
• Bioequivalent and therapeutically equivalent to Atrovent HFA
• 180-day generic exclusivity confirmed
• Planned commercial launch early Q2 2026
• Target market: Atrovent HFA ~$112M (12 months ended 12/31/2025)
• Pipeline filings target combined markets >$1.7B and >$3.7B

Negative

• Exclusivity limited to 180 days
• Approval creates near-term commercialization responsibility and costs
• Forward-looking statements subject to execution and regulatory risks

RANCHO CUCAMONGA, CA / ACCESS Newswire / February 24, 2026 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("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.

"We are excited to announce FDA approval of Ipratropium Bromide HFA Inhalation Aerosol, reinforcing the strength of our integrated R&D and manufacturing model and demonstrating our ability to deliver complex, high-value generics," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. "We expect this launch to contribute meaningfully to our respiratory portfolio and to further strengthen our long-term growth strategy, capabilities and commitment to delivering impactful therapies to patients as we increase our efforts on the development of proprietary pipeline candidates."

Ipratropium is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. According to IQVIA, the U.S. sales for Atrovent^® HFA were approximately $112 million for the 12 months ended December 31, 2025.

Amphastar plans to launch its Ipratropium Bromide HFA Inhalation Aerosol, previously referred to as AMP-007, early in the second quarter of 2026.

Pipeline Information

The Company currently has one ANDA and one biosimilar insulin filed with the FDA targeting products with a combined market size of over $1.7 billion, along with two biosimilar products in development targeting products with a market size exceeding $3.7 billion, and two generic products in development targeting products with a market size of over $1 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2025. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.

The Company's proprietary pipeline also includes four recently in-licensed products including three proprietary peptides targeting oncology and ophthalmology indications, and a fully synthetic corticotropin compound designed to address inflammatory and autoimmune conditions.

About Amphastar Pharmaceuticals, Inc.

Amphastar is a biopharmaceutical company that focuses on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells active pharmaceutical ingredient, or API products. Most of the Company's finished products are contracted and distributed through group purchasing organizations, drug wholesalers, and drug retailers. More information and resources are available at www.amphastar.com.

Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar ^®, BAQSIMI ^®, Primatene MIST ^®, REXTOVY ^®, Amphadase ^®, Ampsilog^TM and Cortrosyn ^®, are the property of Amphastar.

Forward-Looking Statements

All statements in this press release referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth and our ability to continue to scale, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the impact of our products, including their potential for continued revenue growth, the strategic trajectory of and market for our product pipeline, our long-term strategic vision, our ability to leverage our existing expertise and technology, the impacts of any licensing agreements and ability to commercialize additional therapies, our in-house manufacturing expertise, our ability to deliver high-quality, affordable therapies to patients, our commercial momentum and position in the market. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission ("SEC"), including in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 8, 2025, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 6, 2025, and our other filings or reports that we may file with the SEC. In particular, there can be no guarantee that our sales strategies will be successful, or that we will continue to experience significant sales of BAQSIMI ^®. You can locate these reports through our website at http://ir.amphastar.com and on the SEC's website at www.sec.gov. The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.

Contact Information:

Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 476-3416

SOURCE: Amphastar Pharmaceuticals, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Amphastar (AMPH) announce about Ipratropium Bromide HFA on February 24, 2026?

Amphastar announced FDA approval of Ipratropium Bromide HFA 17mcg/actuation and bioequivalence to Atrovent HFA. According to Amphastar, the FDA granted 180 days of generic exclusivity for being the first Paragraph IV ANDA filer, with a planned launch early in Q2 2026.

When will Amphastar (AMPH) launch its approved Ipratropium Bromide HFA product?

Amphastar plans to launch Ipratropium Bromide HFA early in the second quarter of 2026. According to Amphastar, commercial launch will trigger the 180-day exclusivity period granted by the FDA.

How large is the U.S. market for Atrovent HFA that Amphastar (AMPH) will compete with?

IQVIA reports U.S. sales for Atrovent HFA were approximately $112 million for the 12 months ended December 31, 2025. According to Amphastar, this figure represents the near-term addressable market for the approved generic.

What exclusivity did the FDA grant Amphastar (AMPH) for its Ipratropium Bromide HFA ANDA?

The FDA confirmed Amphastar is eligible for 180 days of generic exclusivity as the first Paragraph IV ANDA applicant. According to Amphastar, exclusivity begins on the first commercial launch day.

What other pipeline and filings did Amphastar (AMPH) disclose on February 24, 2026?

Amphastar reported one additional ANDA and one biosimilar insulin filed, plus biosimilars and generics in development targeting multi-billion-dollar markets. According to Amphastar, pipeline targets are based on IQVIA 12-month data through 12/31/2025.

Is Amphastar's Ipratropium Bromide HFA considered equivalent to Boehringer Ingelheim's Atrovent HFA?

Yes. The FDA determined Amphastar's product is bioequivalent and therapeutically equivalent to Boehringer Ingelheim's Atrovent HFA. According to Amphastar, this supports substitutability upon commercial launch.