Drug Research
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Ani Pharmaceuticals to buy generic products from Amneal and Impax

PBR Staff Writer Published 30 April 2018

Ani Pharmaceuticals has agreed to acquire a portfolio of generic products and other assets from Amneal Pharmaceuticals and Impax Laboratories for an undisclosed sum.

The deal is the consequence of a divestiture process mandated by the Federal Trade Commission (FTC) in association with Amneal Pharmaceutical’s proposed business combination with Impax Laboratories.

Under the deal, Ani will acquire five approved generic ANDAs and one pipeline product Erythromycin IR tablets.

The company will also enter into a license, supply and distribution agreement for a second pipeline product, Diclofenac-Misoprostol DR tablets, with a pending ANDA.

According to Iqvia/IMS Health, the combined current annual US market for these seven products is around $1.7bn.

At present three of the five approved products have been commercialized, including Ezetimibe-Simvastatin tablets, Felbamate tablets and Desipramine tablets.

Other two generic products, Aspirin/Dipyridamole ER capsules and Methylphenidate HCl ER tablets secured approval, but not yet commercialized.

Under multi-year supply agreements, the products will be produced and supplied to Ani by Amneal and Impax or pre-existing third-party contract manufacturers.

As per terms of the deal, Ani will receive a supply agreement with the option to secure generic Aspirin/Dipyridamole ER Capsules from Amneal Pharmaceuticals starting in late 2019.

The product is expected to be supplied to the customers in the US by early 2021.

Ani is also eligible to acquire certain manufacturing equipment currently installed at a third-party contract manufacturing facility to produce Methylphenidate HCl ER tablets.

Ani president and CEO Arthur Przybyl said: “The acquisition will align strongly with ANI’s strategic focus to grow our generic pipeline, expand our commercial portfolio, and leverage our U.S. based manufacturing plants.

“Importantly, the acquisition includes several products that compete in exciting markets including Aspirin/Dipyridamole ER Capsules and Methylphenidate ER Tablets.”

Ani is engaged in the development, manufacturing and marketing of branded and generic prescription pharmaceutical products in the areas of narcotics, oncolytics (anti-cancers), hormones and steroids.