Mylan Laboratories (MYL) is the third largest manufacturer of generic pharmaceuticals in the United States. Until 2007, MYL was a relatively small player in a market dominated by giants Teva and Sandoz, Novartis' generics division. Mylan lacked its competitors' economies of scale and couldn't compete as effectively on price. The company also had limited international exposure, with only $3 million (less than 1% of total sales) in revenue coming from Europe in 2006.
In 2007, however, MYL made two transformational acquisitions. It acquired Merck's generic business, effectively doubling its revenues and giving it a significant presence in fast growing European generics market. Earlier in the year, MYL also acquired, a controlling interest in Matrix, an Indian pharmaceutical ingredients manufacturing firm, significantly expanding its manufacturing capacity while lowering its manufacturing costs. The downside to these acquisitions is that they were mostly funded by debt, and the interest expense associated with them, combined with the cost of integrating the two acquisitions, the Merck business in particular, will depress margins until 2009 .
Mylan pursues patent challenges more aggressively than most of its competitors. Rather than waiting for patents to expire, Mylan files challenges which, when successful, allow it to produce the "challenged" drug for 180 days without other generic competition. This strategy, however, comes with the risk of increased exposure to lawsuits and counter-action by the brand manufacturers. MYL has paid $100 million in direct legal and settlement costs from 2003 to 2007. This figure does not include lost revenues from the interruption of sales for drugs that are already in production.
Mylan’s products fall in a wide range of therapeutic categories. It makes 170 drugs in 400 different dosages. 14% of MYL's 2007 revenue came from its sales of calcium channel blockers, primarily its drug nifedipine, and another 19% of revenues came from narcotic agonist analgesics, such as fentanyl. The company currently has 65 applications with 13 “first-to-files” which would mean 180 days of generic marketing exclusivity if successful .
Mylan's 2007 acquisition of Merck's generics business gives it the scale to compete with some Teva and Novartis' Sandoz. Just as Mylan is particularly aggressive in its patent challenges, so is Teva. The giant had 28 challenges filed in 2007, with 15 tentative challenges, compared to Mylan's 13.
Mylan faces competition both from generic and brand name drug producers. Some of its top competitors include: