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J&J Loses Appeal to Halt Generic Zytiga Launch, Stock Down

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A U.S. appeals court rejected J&J’s (JNJ - Free Report) request for a temporary restraining order to prevent the launch of generic versions of prostate cancer drug, Zytiga. J&J’s shares declined more than 3% on Wednesday in response.

So far this year, J&J’s stock has risen 1.7% compared with an increase of 7.6% recorded by the industry.



Zytiga is indicated in combination with prednisone for the treatment of patients suffering from metastatic castration-resistant prostate cancer.

Late last month, a New Jersey district court invalidated J&J’s patent (patent ‘438) related to Zytiga, opening doors for generic launches. The court, however, issued an injunction then saying that no commercial launches of generic products may occur prior to Nov 9. J&J said it will appeal the court’s decision and filed a request with the Federal Circuit to block sales until the appeal is decided.

The U.S. Court of Appeals for the Federal Circuit declined to extend the injunction, ruling that generic makers cannot be stopped from launching copycat versions of its branded drug, which generated sales of $958 million in the third quarter, rising 43% year over year. J&J said it will request the Supreme Court for an emergency order to stop the launch of generic medicines.

Several companies are looking to bring generic versions of 250 mg and/or 500 mg tablets of Zytiga. These include Mylan (MYL - Free Report) , Teva Pharmaceutical Industries Limited (TEVA - Free Report) , Amneal Pharmaceuticals, Inc. (AMRX - Free Report) , Hikma Pharmaceuticals and Dr Reddy’s among others. Mylan, Teva and Hikma have already received FDA approval for their generic versions of Zytiga and can launch their products anytime now, which should result in significant decline in sales of J&J’s branded drug

Zytiga, an important contributor to J&J’s sales growth, was approved in the first-line setting in February, which has been a key driver of Zytiga’s strong performance in the past three quarters.

On the third-quarter call, J&J sounded confident that it can absorb the impact of any potential Zytiga headwind should there be an earlier-than-expected generics launch in 2018. Also, J&J gained FDA approval for another prostate cancer drug, Erleada in February this year. It is being speculated that Erleada will somewhat make up for any lost sales of Zytiga in case a generic is launched this year.

J&J currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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