FDA approves generic versions of Singulair

WHITEHOUSE STATION, N.J.—Another Big Pharma company faces aharrowing view of the abyss from the edge of the patent cliff as the U.S. Foodand Drug Administration on Aug. 3 granted 10 drugmakers marketing approvals forthe first generic forms of Singulair, Merck & Co.'s blockbuster allergy andasthma medication.

Market-watchers say the generic competitors will quicklytake two-thirds of the market share for the drug's sales, with Datamonitorgoing farther to say generic versions will take over 90 percent of the sales inthe United States within a year.

Merck has already made note of the imminent erosion, having mentionedit in the second quarter financial results posted in late June when it said, "Worldwidesales of Singulair, a once-a-day oral medicine for the chronic treatment ofasthma and the relief of symptoms of allergic rhinitis, grew 6 percent to $1.4billion in the second quarter of 2012. The patent for Singulair will expire inthe U.S. in Aug. 2012 and in major European markets in Feb. 2013. The companyexpects a significant and rapid reduction in sales thereafter in those markets."

Merck did note, however, that Singulair will retainmarketing exclusivity in Japan until 2016.

Looking at the generic competition issue more generally inApril, Zacks Investment Research noted that the effects of "genericization" of BigPharma products would be felt mostly this year, "which will be a challengingyear for several companies," the firm noted. "Two major products slated to losepatent protection in 2012 include Merck's Singulair and Bristol-Myers Squibb/Sanofi'sPlavix."

"While generics will eat into sales, new products are notexpected to generate the same level of sales as products losing patentprotection," Zacks further predicted. "The next few years are expected toreflect a significant imbalance between new product introductions and patentlosses."

Or, as Datamonitor put it on Aug. 6, "As anticipated, Merckis about to face a significant decrease in revenue as the first genericversions of its blockbuster Singulair reach the U.S. market. Although Merck'sstrong pipeline is aimed at offsetting the impact of generic erosion, littlecan be done in the immediate future to stem this loss."

In 2011, Merck reported U.S. sales of $3.5 billion forSingulair and global sales of $5 billion.

Merck has plans to get approvals for six drugs over the nextyear-and-a-half, including new medications for osteoporosis and insomnia, as itprepares for Singular—a drug which, unlike most allergy drugs blocks leukotrienesrather than histamine—to lose its luster.