The Breakup: Merck and Singulair No Longer Exclusive

The FDA gave approval on Friday for ten drugmakers to begin marketing generic versions of Singulair, Merck’s (NYSE:MRK) $5B asthma treatment. Investors and analysts have been anticipating generic introduction for some time, but Friday’s approvals makes the changes a reality; analysts expect generics to swiftly take 60% of sales. Teva (NYSE:TEVA) and Novartis (NYSE:NVS) are just two of the competitors joining the arena.

The company has been preparing this year for the loss, explaining plans for six drug filings in the next year and a half. Merck retains market exclusivity for Singulair in Europe through 2013, and in Japan through 2016. MRK surpassed analyst expectations in July when second quarter earnings were announced; Singulair sales were up 6% from the previous year and accounted for 11% of revenue in 2011. Merck maintains its 2012 guidance of $3.75-$3.85 EPS.