ANI Pharmaceuticals has signed definitive agreements to acquire a portfolio of generic products and other assets from Amneal Pharmaceuticals and Impax Laboratories for an undisclosed cash consideration. The parties expect to close the transaction in early May.

Upon closing the transaction, ANI will acquire a product portfolio consisting of five approved generic ANDAs and one pipeline product, Erythromycin IR tablets. ANI will also acquire a license, supply and distribution agreement for a second pipeline product, Diclofenac-Misoprostol DR tablets, with a pending ANDA.  The combined current annual U.S. market for these seven products is approximately $1.7 billion, according to Iqvia/IMS Health.

Currently three of the five approved products are commercialized: Ezetimibe-Simvastatin Tablets (ANDA 201890), Felbamate Tablets (ANDA 202284) and Desipramine Tablets (ANDA 205153).  Following the close of the transaction, ANI will begin shipping these products to customers immediately.  Two generic products are approved but not yet commercialized: Aspirin/Dipyridamole ER Capsules (ANDA 206964) and Methylphenidate HCl ER Tablets (ANDA 208607).  These products will be manufactured and supplied to ANI under multi-year supply agreements with Amneal, Impax, or pre-existing third-party contract manufacturers under agreements that will be assigned to ANI.  ANI intends to immediately commence efforts to tech transfer the manufacturing of the acquired ANDA for Aspirin/Dipyridamole ER Capsules to the company’s Baudette manufacturing facility.

As part of the transaction, ANI will secure a supply agreement with the option to receive generic Aspirin/Dipyridamole ER Capsules from Amneal Pharmaceuticals beginning in late 2019 with a right to distribute the product in the U.S. market through early 2021.  If ANI exercises this option it may be obligated to make a milestone payment upon launch depending on the number of generic products in the market at the time of launch.

In addition, ANI will acquire certain manufacturing equipment currently installed at a third-party contract manufacturing site for the manufacture of Methylphenidate HCl ER Tablets.

Arthur S. Przybyl, ANI’s president and chief executive officer, stated, “We are pleased to announce the agreement to acquire these exciting generic products and assets.  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.”