According to a press release issued on Wednesday, the Federal Trade Commission (FTC) is requiring generic drug marketers ANI Pharmaceuticals Inc. and Novitium Pharma LLC to divest ANI’s development rights to a generic drug and its assets with respect to another generic if the companies wish to consummate the acquisition. Under the terms of the proposed deal, Prasco LLC will receive the rights to develop generic sulfamethoxazole-trimethoprim oral suspension (SMX-TMP), an antibiotic reportedly used to treat common infections, and will buy the company’s assets relating to generic dexamethasone, a drug used to treat inflammation.
The announcement comes after the FTC voted 4-0 to both issue a complaint and accept the proposed consent order. The complaint explained that the FTC examined the development, license, manufacture, marketing, distribution, and sale of certain forms of generics SMX-TMP and dexamethasone. As to SMX-TMP oral suspension, ANI is a current market participant, and Novitium is one of just a few companies well-positioned to enter.
Both ANI and Novitium have products in development in the market for the oral steroid dexamethasone, the complaint said. “Acquisition would eliminate a potential entrant in an already concentrated market,” the FTC concluded. As such, the agency determined that the proposed purchase would likely harm future competition in the domestic markets for both products.
The order found that Prasco is a competent purchaser with experience marketing and distributing generic pharmaceutical products and will be able to replace the lost competition. The FTC also set forth several parameters to protect competition in the future, including that ANI and Novitium must obtain approval before acquiring any other SMX-TMP oral suspension or dexamethasone tablet product.
Once the consent agreement is published in the Federal Register, the public comment period will be open for 30 days.
