FTC Orders Divestment of Generic Antibiotics

On Thursday the Federal Trade Commission (FTC) released a final order requiring generic drug marketers ANI Pharmaceuticals Inc. and Novitium Pharma LLC to divest rights and assets to generic Sulfamethoxazole-Trimethoprim oral suspension and generic Dexamethsone tablets.

ANI Pharmaceuticals and Novitium Pharma LLC began an acquisition and merger process in spring of 2021. A complaint was made to the FTC that this merger had the potential of creating a monopoly regarding the production and sale of Sulfamethoxazole-Trimethoprim oral suspension and generic Dexamethsone tablets.

Generic SMX-TMP oral suspension is an antibiotic used to treat a variety of infections, including ear infections, urinary tract infections, and bronchitis. Generic dexamethasone tablets are an oral steroid product used to treat inflammation associated with a variety of conditions, including certain types of arthritis, allergic reactions, skin diseases, and breathing problems.

As a part of the review of the complaint, a settlement was negotiated that required the sale of the ANI Pharmaceiticals rights and assets regarding these drugs to Prasco LLC, a third party competitor, in order to preserve the competitive market for these products.

The order was issued after a 30 day comment period. The FTC vote to accept the order was 6-0 in favor.