US-based ANI Pharmaceuticals has entered definitive agreements to buy generic products and additional assets from Amneal Pharmaceuticals and Impax Laboratories.

The transaction is the result of a divestiture process mandated by the Federal Trade Commission in connection with Amneal Pharmaceutical’s proposed business combination with Impax Laboratories.

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While the financial details have not been disclosed, the transaction is said to include a portfolio of five approved generic abbreviated new drug applications (ANDAs) and two pipeline products.

The generic portfolio is made up of Ezetimibe-Simvastatin, Felbamate, Desipramine and Methylphenidate HCl ER Tablets, and Aspirin/Dipyridamole ER Capsules.

Ezetimibe-Simvastatin, Felbamate and Desipramine have already been approved and ANI intends to commence shipping after the completion of the acquisition.

Aspirin/Dipyridamole and Methylphenidate HCl are yet to receive approval. These products will be produced and supplied to ANI through multi-year supply agreements with Amneal/Impax.

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“The acquisition will align strongly with ANI’s strategic focus to grow our generic pipeline, expand our commercial portfolio, and leverage our US-based manufacturing plants.”

They may also be provided by pre-existing third-party contract manufacturers under agreements that will be given to ANI.

Additionally, ANI will secure Erythromycin IR Tablets, along with licence, supply and distribution agreement for Diclofenac-Misoprostol DR Tablets.

Together, the current annual worth of these seven products in the US market is estimated to be $1.7bn by Iqvia/IMS Health.

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 US-based manufacturing plants.

“Following the close of the transaction, ANI will immediately begin the work necessary to pursue the launch of these approved ANDAs, which represent considerable commercial opportunities.”

The company plans to tech transfer the manufacturing of the Aspirin/Dipyridamole ER Capsules to its Baudette manufacturing facility.

It will sign a supply agreement with the option to receive the products from Amneal late next year and a right to distribute them in the US through early 2021.

ANI will also gain some manufacturing equipment that is currently at a third-party contract manufacturing site for the Methylphenidate HCl ER Tablet production.