Transpire Bio's ANDA For Generic Trelegy® Ellipta® Accepted For Filing By The U.S. FDA

(MENAFN- GlobeNewsWire - Nasdaq) SUNRISE, Fla., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Transpire Bio, an integrated clinical-stage biopharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases, today announces that its abbreviated new drug application (ANDA) for fluticasone furoate, umeclidinium, and vilanterol inhalation powder, a generic version of Trelegy® Ellipta®¹ 100/62.5/25, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Based on the FDA's public records,² Transpire Bio believes that it was the first company to file an ANDA with a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should Transpire Bio be the first to file an ANDA against the RLD, the company may become eligible for 180 days of market exclusivity. In the U.S., Trelegy® Ellipta® is indicated for the maintenance treatment of asthma in patients 18 years and older and the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). According to the GSK Annual Report, Trelegy® Ellipta® recorded U.S. annual net sales of nearly $2.7 Billion³in 2024.

“The FDA's acceptance for filing of our ANDA for fluticasone furoate, umeclidinium, and vilanterol inhalation powder, a generic version of Trelegy® Ellipta®, is another major milestone in advancing our complex generic franchise,” said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio.“Our highly experienced team in South Florida continues to work tirelessly to achieve important milestones like this. We are now one step closer to providing patients suffering from asthma or COPD with an affordable option and improved access to this critical medication.”“This milestone is a result of Transpire Bio's deep scientific and technical competence, and demonstrates Transpire Bio's strong capabilities in developing complex drug device combination products,” said Dr. Abhishek Gupta, Chief Scientific Officer of Transpire Bio.
In addition to its focused generic franchise, Transpire Bio is building a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF), with three assets in development. Transpire Bio is also developing therapies for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, and neurological diseases. These products are being developed and manufactured in Transpire Bio's state-of-the-art manufacturing facilities located in South Florida, U.S.

Trelegy® Ellipta® is a registered trademark of the GSK group of companies

FDA's list of drug products for which an ANDA has been received by the Office of Generic Drugs containing a“Paragraph IV” patent certification

GSK Annual Report 2024

About Transpire Bio Inc.
Transpire Bio Inc. is an integrated US-based, clinical-stage biopharmaceutical company headquartered in Sunrise, Florida. Transpire Bio harnesses its inhaled drug delivery expertise to improve patients' lives by expanding access to important therapies and developing treatments for serious diseases where therapeutic options are significantly lacking. Transpire Bio has developed multiple proprietary inhalation technology platforms, including dry-powder inhalers and soft-mist inhalers. For more information, please visit .

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