Zetia (ezetimibe), a blockbuster anti-cholesterol drug originally patented by Merck & Co (Merck) with US sales over US$2.6 billion for the year ending 30 September 2016, has come to the end of its patent protection. The drug is now threatened by its first generic version, produced by Par Pharmaceutical (Par), an operating company of Dublin’s Endo International (Endo). Working in partnership with Glenmark Pharmaceuticals, Endo began shipping 10 mg ezetimibe tablets on 12 December 2016.

Under US Food and Drug Administration (FDA) rules, Endo will have exclusive rights to the generic for the first six months, after which time Merck’s Zetia sales are likely to decline further as more generics makers enter the market.

The launch could also threaten sales of Merck’s Vytorin, which is a combination of Zetia and the statin simvastatin (Zocor). The combination of ezetimibe with a statin has been shown to reduce cardiovascular risk in patients with acute coronary syndrome, where reduced blood flow through the coronary arteries affects the function of the heart. Combined, Zetia and Vytorin are expected to generate almost US$2 billion in 2017.

Analysts from Barclays said loss of Zetia exclusivity will harm Merck’s earnings more than its sales, while Goldman Sachs commented that much of the recent growth in income from the drug has been due to price rises. The more affordable generic form of Zetia may also take sales from more expensive anti-cholesterol drugs such as Praluent (alirocumab) and Repatha (evolocumab), produced by Sanofi and Amgen, respectively.

Although this may be concerning news for Merck, for Endo the Zetia generics will provide an opportunity for the company to boost its revenue following recent economic troubles. The company bought Par in 2015 for the significant sum of US$8 billion [1] and recently had to lose 375 employees and stop work to develop a new pain medication.

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Reference
GaBI Online - Generics and Biosimilars Initiative. Acquisitions for Endo and Strides [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Pharma-News/Acquisitions-for-Endo-and-Strides

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