For the nine months up to the end of September 2013, sales of the anti-depressive disorder drug stood at $4.2bn (€3.1bn) worldwide but last week the bestseller’s patent expired allowing a glut of low cost generic versions to cut into its sales.
In a third quarter conference call (transcript here), CFO Derica Rice told stakeholder “US Cymbalta sales will come in well below current consensus” and, following the December 11 patent expiration, Lilly expected “minimal wholesaler repurchases.”
Lilly has already implemented a response to potential plummet in sales by issuing a Worker Adjustment and Retaining Notification (WARN) in April and cutting hundreds of jobs in its US sales force, but in-Pharmatechnologist.com asked the company how production would be affected.
Spokesman Andrew McLaughlin said: “As we scale back Cymbalta manufacturing, the majority of people involved in Cymbalta production are finding opportunities in other areas of manufacturing, such as diabetes, where we anticipate growth.”
In November the firm pledged $700m across a number of sites globally to increase its insulin capacity in a response to the “growing diabetes epidemic,” McLaughlin told us last month.
This news brought the total figure invested in Lilly’s Indianapolis, US, site - which produces Cymbalta as well as being the firm's global headquarters - to over $500m in the last few years, and continues the company’s five-year plan of doubling its insulin capacity without adding plants to its network, which was announced in 2012.
Boon for generics firms
On the day of its expiration, the US Food and Drug Administration (FDA) approved the first generic versions of Cymbalta (Duloxetine Hydrochloride), with Aurobindo, Dr Reddy’s, Lupin, Sun pharma, Teva and Torrent poised to begin selling.
Sun Pharma spokesperson Mira Desai told this publication: “We have already launched the product which is manufactured at one of our USFDA approved facilities.”
Furthermore, Aurobindo issued a statement Friday announcing its approval to manufacture its generic for the treatment of major depressive disorder (MDD), a market it estimates at $5.4bn.