Legal Wrangling Over Generics
The escalating war between brand-name and generics companies isn't getting any easier, making it difficult to pin down patent expiration dates. Recent regulatory and legal decisions continue to muddy the field. In particular, a US District Court Judge ruled on the trigger date for 180-day exclusivity, a controversial ruling that has the generics industry up in arms.
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FTC Boosts Generics, Bloodies Brands
Biovail's stock plummeted recently after a sell recommendation from a highly-regarded Wall Street analyst--who's been accused of a conflict of interest for issuing it--and an FTC ruling on its alleged anti-competitive practices. The ruling, on late-listed Orange Book entries, will curtain common anti-generic strategies.
Mylan's New Focus
For most of the 1990s, Mylan Laboratories was the dominant US generics manufacturer both in terms of financial performance and creative competitive strategies. But it seems to have lost its way a bit and is struggling to regain its competitive edge in an industry that no longer reflects the world it grew up in. Revenues grew a sluggish 7% to $846 million in 2001, in part because efforts to diversify into proprietary drugs haven't met goals. In June, two top executives left, both of whom had been there only a short time.
Third Time’s A Charm? US FDA Once Again Proposes Mandatory Consumer Rx Info
The US Food & Drug Administration is once again proposing a mandatory summary of key labeling information be dispensed with every prescription drug. Will the idea stay on the books this time?