Pfizer Inc. (NYSE:PFE) Lyrica CR Approved By FDA As Patent Expiry Date Nears


The U.S. Food and Drug Administration has given its approval for Pfizer Inc. (NYSE:PFE) Lyrica CR, which is a longer-lasting version of Lyrica. This comes amidst expected competition as the patent for Lyrica in the United States is set to expire in December.

The approval will see Lyrica CR, to be taken once a day, allowed for use as a treatment for pain caused by diabetic peripheral neuropathy or shingles. Lyrica CR has however not received approval for the treatment of pain brought about by fibromyalgia unlike Lyrica itself which has this indication.

Once-daily dosing

“LYRICA CR was developed to offer patients an effective treatment option with the convenience of once-daily dosing. It provides an important option for patients and health care providers managing these often debilitating pain conditions,” said the Chief Development Officer of Pfizer, James Rusnak.

With the expiry of the Lyrica patent cheap copycats are expected to flood the market and Pfizer will be hoping the new formulation will convince its current customers to stick with the brand. Over half a dozen makers of generic drugs have received approvals to sell Lyrica copies.

Blockbuster drug

When facing competition from generics pharmaceutical companies often introduce new version of their drugs hoping patients will stay with the brand. A representative of Pfizer couldn’t however say whether the pharmaceutical giant is of the view that current users of Lyrica would switch to the new version.

Last year Lyrica generated approximately $3.13 billion in sales in the United States. This was a year-on-year growth of 26%. As the Lyrica patent nears expiration, Pfizer has been conducting a heavy promotion of its drug on television as well as raising prices. In September Lyrica was the most heavily advertised drug on television according to, an ad tracker. Previously the most heavily advertised drug on TV was Humira, an anti-inflammatory drug developed by AbbVie Inc (NYSE:ABBV). Four months ago Lyrica’s price was increased and this came after another price increase of 9.4% which was effected last year.

On Thursday shares of Pfizer Inc fell by 0.26% to close the day at $36.35.

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