Equine Generic Omeprazole Paste

FDA Approves First Generic Omeprazole Paste for Gastric Ulcers in Horses

The U.S. Food and Drug Administration has approved Gastrobim (omeprazole) oral paste, the first generic version of a widely used treatment for gastric ulcers in horses.

Gastrobim is indicated for both the treatment of gastric ulcers and the prevention of recurrence in horses and foals four weeks of age and older.

Drug Overview

Gastrobim is a proton pump inhibitor (PPI), a class of drugs that reduces stomach acid by blocking acid secretion in the stomach lining. The product contains the same active ingredient, omeprazole, as the reference listed drug, Gastrogard, which was originally approved in 1999.

The FDA determined that Gastrobim is bioequivalent to the brand-name product, meaning it is expected to provide the same therapeutic effect.

Dosing and Administration

Gastrobim is administered orally and is available by prescription only through a licensed veterinarian. Typical dosing includes once daily for four weeks at 1.8 mg/lb (4 mg/kg) for the treatment phase, and continued use for at least four additional weeks at 0.9 mg/lb (2 mg/kg) for the prevention phase.

Manufacturer

Gastrobim is sponsored by Bimeda Animal Health Ltd., based in Ireland.

MDP Regulatory Analysis

This approval reflects several important trends in veterinary and regulated product markets.

Expansion of Generic Animal Health Products

The approval of a generic equivalent introduces increased competition that could lead to a potential cost reduction for animal care and expanded access for veterinary treatment.

Regulatory Parity with Human Generics

The FDA’s determination of bioequivalence mirrors human pharmaceutical pathways, reinforcing that veterinary drugs are subject to rigorous scientific evaluation, and that generic approvals require demonstration of equivalent safety and effectiveness.

Lifecycle Maturity of Established Therapies

With the reference product approved in 1999, this approval reflects long-term clinical use and established safety profile and a transition from innovation to broader market accessibility.

Growing Importance of Veterinary Therapeutics

Animal health continues to expand as a regulated sector, particularly in the care of companion animals and performance animals (e.g., equine medicine), and food supply and agricultural applications.

Conclusion

The approval of Gastrobim demonstrates how established therapies evolve into more accessible treatment options through generic pathways, while maintaining regulatory rigor and clinical confidence.