FDA Approves Perrigo Company plc. (NYSE:PRGO) Generic Version of AstraZeneca plc. (ADR)(NYSE:AZN) Nexium

Perrigo Company plc

The Food and Drug Administration has granted Perrigo Company plc. Ordinary Shares (NYSE:PRGO) the green light to sell its over the counter version of AstraZeneca plc. (ADR)(NYSE:AZN) Nexium 24hr capsules. The approval according to executive vice president, Jeff Needham, affirms the company’s tremendous capabilities in the store brand OTC platform.

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Perrigo Robust OTC Portfolio

AstraZeneca Nexium capsules generated sales in excess of $300 million last year. Perrigo is currently finalizing launch plans as it moves to flex its muscles in the space.

“Important product launches like the store brand equivalent of Nexium® 24HR capsules are what drive the Perrigo advantage by providing our customers, consumers and families with high quality, value alternatives in important treatment categories,” said Mr. Needham.

In addition to gaining regulatory approval for the OTC equivalent of Nexium, Perrigo has also reached a settlement with AstraZeneca in relation to patent litigation for its generic drug. The settlement allows the company to launch its generic capsules in September.

The launch of the Nexium generic capsules should go a long way in strengthening Perrigo product offerings in the over the counter market. In 2015, the company acquired Omega Pharma a transaction that provided it with access to well established OTC bands such as Niquitin and Coldrex. The same year the company acquired Scarway, which provided it with an entry into the branded OTC business in the U.S.


Pursuit of growth on the OTC market comes on the heels of Perrigo announcing a number of divestitures during its second quarter earnings call. The company is in the process of offloading its active ingredients business to investment firm SK Capital LP for $110 million. The unit develops generic APIs and the transaction is poised to close in the fourth quarter.

Perrigo has also divested royalty stream for its multiple sclerosis drugs, Tysabri for $2.85 billion. The selloff comes on the heels of activist investor, Starboard, urging the company to divest a number of non-core assets.

Perrigo was up by 1.31% in Tuesday’s trading session to end the day at $78.6 a share.

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