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Spirogen Ltd.

Division of AstraZeneca PLC
www.spirogen.com

Latest From Purepac Pharmaceutical Co.

Andrx's New-Style Generics

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.
BioPharmaceutical Strategy

Latest Uproar in Generics:180-day Exclusivity

Legal strategies are getting ever more sophisticated in the war between generics and brand-name companies. Some generics companies are in an uproar about a new wrinkle in their efforts to bring lower-priced drugs to market; because of a series of court decisions that upset an FDA practice, generics companies that are first to file for approval of a drug in which they think the patent may be challenged are entitled to 6 months market exclusivity. Previously, the FDA required a lawsuit to be underway in order for generics companies to get exclusivity, but now, a company can get the exclusivity just by making the claim that they might be subjected to a lawsuit. Generics companies worry that their competitors will take advantage of the policy by rushing to file sub-standard ANDAs just to be able to get the market exclusivity; in addition, they might try to strike deals with brand name companies that would give them a reward for keeping other generics companies off the market entirely.
BioPharmaceutical Business Strategies
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Company Information

  • Industry
  • Biotechnology
    • Drug Discovery Tools
      • Genomics-Proteomics
      • Molecular Diversity
        • Natural Products
  • Pharmaceuticals
  • Therapeutic Areas
  • Cancer
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • UK
  • Parent & Subsidiaries
  • AstraZeneca PLC
  • Senior Management
  • Chris Martin, MD, CEO
    Tuula Moilanen, CFO
    Philip Howard, PhD, CSO
  • Contact Info
  • Spirogen Ltd.
    Phone: (44) 207 278 0555
    QMB Innovation Centre
    42 New Rd.
    London, E1 2AX
    UK
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