Lilly’s top-selling depression treatment Cymbalta is facing direct competition for the first time in the US after the Food and Drug Administration (FDA) cleared six generic versions of the drug yesterday.
Cymbalta (duloxetine) accounted for a little over $4bn in sales in the first nine months of the year, almost a quarter of Lilly’s total revenue of $16.6bn in the period, with the US accounting for $3.4bn of the total.
At a time when some of its peers in the pharma sector have started to talk about moving beyond the ‘patent cliff’, Lilly is still very much in the thick of it. The company is also facing patent expiration in the US next March on its Evista (raloxifene) treatment for osteoporosis, which has added $775m to its coffers in 2013 so far.
The FDA approved generic versions of Cymbalta in various strengths from Aurobindo, Dr Reddy’s Laboratories, Lupin, Sun Pharma, Teva and Torrent Pharmaceuticals the moment the Lilly’s patent expired.
“Healthcare professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, acting director of the FDA’s Office of Generic Drugs. “Generic drugs offer greater access to healthcare for many people.”
During the company’s third-quarter results call, Lilly’s chief financial officer Derica Rice said he expected “minimal wholesaler purchases” in the build-up to the patent expiry, and this meant that sales of the drug will likely halve to around $500m in the fourth quarter of the year.
Anticipating the impact on Cymbalta and Evista, Lilly has already reduced the size of its US sales force by around 30 per cent and frozen pay levels for its 38,000 global employees in a bid to preserve profitability in the face of the steep revenue declines.
Lilly is banking on the performance of new products such as Boehringer Ingelheim-partnered diabetes candidate empagliflozin, which has already been filed for approval, to help it recover from its patent cliff. It suffered a major setback in its pipeline earlier this month however when Cymbalta follow-up edivoxetine failed to meet the primary objectives of three late-stage studies.
Other late-stage projects emerging from its pipeline include gastric cancer drug ramucirumab (which failed in breast cancer trials), long-acting diabetes therapy dulaglutide and rheumatoid arthritis candidate baricitinib.