Amneal Pharmaceuticals and Impax Laboratories yesterday announced that they have completed a previously announced business combination to form Amneal Pharmaceuticals, Inc.
Also yesterday, the specialty pharmaceutical company ANI – which develops, manufactures, and markets branded and generic prescription pharmaceuticals – purchased generic products and assets from the newly-combined company for $2.3m in cash.
According to IQVIA/IMS Health, the portfolio of generic products has a combined current annual market of $1.7bn.
ANI said the transaction provides it with immediate revenue and profit from twelve SKUs (stock keeping units) of three commercialized products, including Ezetimibe-Simvastatin tablets, Felbamate tablets and Desipramine tablets.
The company also acquires approved ANDAs for Aspirin/Dipyridamole ER capsules and Methylphenidate ER tablets, for which it will begin validation efforts.
According to the company, it has an option with a date certain launch for Aspirin/Dipyridamole ER capsules of no later than October 1, 2019. If exercised, the option would allow ANI to source the product from Amneal through March 1, 2021 or until ANI launches its own product.
If ANI launches the product supplied by Amneal it could owe a milestone payment of up to $10m.
Arthur S. Przybyl, ANI's President and CEO said in a press release: "We are excited to add these products and the revenue and profit generated by today's three product launches to our generic platform. Importantly, we look forward to launching Aspirin/Dipyridamole ER capsules no later than October 1, 2019. At the same time, we will begin validation efforts for Methylphenidate ER tablets, which represents a compelling opportunity for ANI."