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.
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Times may be a-changing for generics companies. Last month, Ivax won FDA approval for its generic version of Bristol-Myers Squibb's blockbuster cancer therapy Taxol.
Andrx is at the forefront of a new breed of generics companies: diversified, entrepreneurial, litigious, and competent at handling complex science. In the mid-1990s, when the last big wave of patent expirations created huge opportunities for generics, the industry responded with debilitating price wars, conniving tactics to tie up raw material supplies, and too many me-too drugs. These days are gone. Industry consolidation has weeded out weaker players, helping to stabilize pricing and increase resources, and generics companies are far more sophisticated and diversified than in the past. Andrx picked up early on trends in the industry--its founders saw a gap in generic distribution that others didn't see, and set up a generic drug distribution business to service independent pharmacies. It was among the first to realize that one way to avoid price wars would be to focus on hard-to-manufacture products using innovative technologies to avoid infringing patents. It has from its inception emphasized diversification, positioning itself as a drug delivery company that can apply its proprietary technologies to both generics and branded products. It is evolving into branded products, first by in-licensing niche, undermarketed drugs from big pharma companies, and then by developing improved versions of branded drugs that are about to go off patent. But being a drug delivery company is tough, and Andrx has yet to prove that it has both a creative enough drug delivery technology and the marketing savvy to be a success at it.
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.