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www.fdanews.com/articles/163925-ftc-seeks-public-comments-on-akornhi-tech-pharmacal-consent-agreement

FTC Seeks Public Comments on Akorn/Hi-Tech Pharmacal Consent Agreement

April 18, 2014

Akorn Enterprises or the company it seeks to acquire, Hi-Tech Pharmacal, must sell all rights and assets to five ophthalmic and anesthesia products to ensure continued competition in those markets, the Federal Trade Commission says in a draft consent agreement published today.

The agreement would require one or the other drugmaker to divest the rights and assets to generic versions of three ophthalmic prescription products — Ciloxan, Ilotycin ointment and Quixin drops — to Watson Laboratories. They would also have to sell Watson the rights and assets to generics of anesthetic products Xylocaine jelly and EMLA cream, transfer the manufacturing technologies and supply Watson with all products during the transition.

According to the FTC, the Akorn and Hi-Tech currently command 28 percent of the generic Ciloxan (ciprofloxacin HCl) market, 38 percent of the generic Quixin (levofloxacin)  market, ˃50 percent of the generic Xylocaine (lidocaine) market and 70 percent of the EMLA (lidocaine and prilocaine) generic and branded markets.

Hi-Tech is expected to enter the generic Ilotycin (erythromycin) market soon, “depriving consumers of increased competition … and price reductions,” the consent agreement says.

The $640 million acquisition was completed this month, giving Akorn access to Hi-Tech’s 56 generic topical creams and ointments and sterile liquid ophthalmic and inhalation products.

Comments on the proposed consent agreement are due to https://ftcpublic.commentworks.com/ftc/akornconsent by May 14.

Documents relevant to the case are at www.fdanews.com/ext/resources/files/04/04-21-14-CaseDocuments.pdf. Read the Federal Register notice at www.fdanews.com/ext/resources/files/04/04-21-14-Acquisition.pdf. — Lena Freund

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