Mylan Inc. (MYL) recently announced that it has launched its generic version of Abbott Laboratories’ (ABT) Trilipix. The drug is approved as an adjunct to diet in combination with a statin to bring down the levels of triglyceride and increase high-density lipoprotein cholesterol.
Mylan launched the drug following approval from the US Food and Drug Administration of the abbreviated new drug application (ANDA) filed by the company seeking approval to market its generic version of Trilipix. Mylan’s generic unit has seen quite a few launches over the past few months. The segment is expected to continue performing well, thereby driving growth at Mylan.
In a separate development, Mylan was recently sued by UCB (UCBJY) The patent challenge follows the generic company's filing of an ANDA as it seeks to market its generic version of UCB’s Vimpat (lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg).
Vimpat has been approved as an adjunctive therapy for treating patients, aged 17 years and above, suffering from partial-onset seizures with epilepsy. Apart from UCB Research Corporation Technologies, Inc., Harris FRC Corporation have also challenged Mylan’s ANDA.
Mylan believes it may be the first-to-file an ANDA for a generic version of Vimpat – if this is the case, the company would be entitled to 180 days of exclusivity on gaining approval from the US Food and Drug Administration (:FDA) for its candidate. As per IMS Health data, Vimpat sales in the US were $338 million for the twelve months ended Mar 31, 2013.
Mylan, one of the largest players in the global generics market, has a presence in more than 140 countries. As of Jul 15, 2013, the company had 173 ANDAs pending FDA approval, representing $82.9 billion in annual sales. These include 35 first-to-file opportunities.
Mylan carries a Zacks Rank #3 (Hold). Actavis, Inc. (ACT) appears to be more attractive in the generic space with a Zacks Rank #2 (Buy).
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