Bimeda launches first FDA-approved generic omeprazole for horses

Bimeda has launched GASTROBIM™ (omeprazole) in the U.S., giving equine practitioners the first FDA-approved generic oral paste that’s been deemed bioequivalent to GastroGard® for treating gastric ulcers and preventing recurrence in horses and foals 4 weeks of age and older. FDA approved Gastrobim on April 6, 2026, under ANADA 200-842, and Bimeda announced nationwide availability on May 5, 2026. The product is prescription-only, uses the same active ingredient as GastroGard, and carries the same labeled dosing schedule: 4 mg/kg once daily for 4 weeks for treatment, followed by 2 mg/kg daily for at least 4 more weeks to prevent recurrence. (fda.gov)

Why it matters: Equine gastric ulcer syndrome is common, especially in performance horses, and omeprazole remains the only FDA-approved pharmaceutical treatment class for these ulcers in horses. UC Davis estimates prevalence at 50% to 90%, and notes that lower-cost, unapproved compounded omeprazole products can vary in potency and performance. For veterinarians, an FDA-approved bioequivalent generic could widen access, support treatment adherence for pet parents facing cost pressure, and offer a regulated alternative in a category long dominated by a single branded prescription product approved in 1999. (ceh.vetmed.ucdavis.edu)

What to watch: The key next question is whether GASTROBIM meaningfully changes prescribing patterns, pricing, and reliance on compounded omeprazole in equine practice over the next 6 to 12 months. (fda.gov)