Settlement Reached in ANI Pharmaceuticals Antitrust Lawsuit

The Federal Trade Commission announced in a press release Wednesday approval of the final order settling charges that the $210 million acquisition of Novitium Pharma LLC by ANI Pharmaceuticals Inc. violated federal antitrust law. 

The complaint, filed in November 2021, alleges that the proposed acquisition would harm competition for generic antibiotic SMX-TMP oral suspension and generic oral steroid dexamethasone. Only five companies, including ANI, currently sell SMX-TMP in the United States, and Novitium is one of a limited number of suppliers capable of entering the market in the near future. Four milligram strength dexamethasone tablets are the most widely used in the United States and are only sold by two companies in the country, with ANI and Novitium two of a limited number of companies entering the market in the near future. Eliminating competition between ANI and Novitium may result in the combined entity forgoing or delaying the launch of each product and increasing their market prices, the lawsuit claims.

The final order requires ANI to divest its SMX-TMP and dexamethasone assets to Prasco LLC within 10 days of its acquisition of Novitium. It also requires respondents to obtain prior approval from the FTC for future acquisitions in these markets. 

The FTC vote to approve the final order was 4-0, according to the press release.