Bimeda launches first FDA-approved generic omeprazole for horses

Bimeda’s U.S. launch of GASTROBIM™ marks a notable shift in equine gastric ulcer treatment: veterinarians now have the first FDA-approved generic omeprazole oral paste shown to be bioequivalent to GastroGard®. FDA approved the product on April 6, 2026, for treatment of gastric ulcers and prevention of recurrence in horses and foals 4 weeks of age and older, and Bimeda announced nationwide commercial availability on May 5. (fda.gov)

That’s significant because GastroGard has been the reference product in this space since its FDA approval in 1999. For years, equine practitioners have managed a common condition with a limited number of labeled, FDA-approved options, while also navigating pet parent concerns about cost and the uneven quality of some compounded alternatives. FDA’s approval pathway for Gastrobim was an abbreviated new animal drug application, meaning Bimeda had to demonstrate bioequivalence to the reference listed new animal drug rather than repeat the full efficacy and safety package. (fda.gov)

The regulatory details matter here. According to FDA’s freedom of information summary, Gastrobim is a 37% w/w omeprazole oral paste supplied in adjustable-dose syringes, available in boxes of 7 or 72 units, and approved as prescription-only. The agency said Bimeda conducted an in vivo blood-level study in horses showing bioequivalence to GastroGard, with no serious adverse events reported in that study. Label directions mirror the established omeprazole regimen: 4 mg/kg once daily for 4 weeks for treatment, then 2 mg/kg daily for at least 4 additional weeks to prevent recurrence. (animaldrugsatfda.fda.gov)

Bimeda is positioning the product as a clinically equivalent alternative and says it has already gained traction in Canada and Europe since its 2024 launch there. On the brand site, the company also frames GASTROBIM as a lower-cost option, though it does not publicly list U.S. pricing. That cost angle is likely to be central to market uptake, especially in practices serving performance horses that may need treatment plus maintenance dosing during ongoing training or other stressors. (bimedaus.com)

Independent expert reaction was limited in the immediate coverage available, but the broader clinical context is clear. UC Davis says equine gastric ulcers are common, with prevalence estimated between 50% and 90%, and notes that definitive diagnosis requires gastroscopy. The center also cautions that some cheaper compounded omeprazole products may contain less active ingredient than labeled and show variable acid suppression and ulcer healing. That helps explain why an FDA-reviewed, bioequivalent generic could draw interest from equine veterinarians looking for a middle ground between branded therapy and less predictable nonapproved alternatives. (ceh.vetmed.ucdavis.edu)

Why it matters: For veterinary professionals, this is less about a brand launch than a formulary change in a high-use therapeutic category. A generic, FDA-approved omeprazole paste may improve affordability and treatment continuity, particularly when veterinarians want to keep cases on labeled therapy for both initial treatment and recurrence prevention. It may also give practices a clearer compliance and counseling message for pet parents: same active ingredient, FDA-reviewed bioequivalence, prescription oversight, and labeled use in horses and foals 4 weeks and older. At the same time, clinicians will still need to emphasize that ulcers are not just a drug problem. Management, feeding strategy, training intensity, transport stress, NSAID exposure, and follow-up gastroscopy remain part of good care. (fda.gov)

Another nuance is that equine gastric ulcer syndrome isn’t a one-size-fits-all diagnosis. Reviews and consensus literature distinguish squamous and glandular disease, with different risk factors and sometimes different management needs. Omeprazole is a cornerstone therapy for acid suppression, but recurrence can happen quickly when treatment stops and ulcerogenic conditions continue. That means the availability of a generic may help with access, but it won’t eliminate the need for case selection, diagnostics, and management counseling. (sciencedirect.com)

What to watch: Watch for distributor rollout, real-world pricing, and whether practices begin shifting away from compounded omeprazole toward FDA-approved generic prescribing. It’ll also be worth tracking whether Boehringer adjusts GastroGard positioning or pricing in response, and whether equine clinicians report any practical differences in acceptance, adherence, or refill behavior once GASTROBIM is in routine use. (bimedaus.com)