7 Unique Challenges Facing the US Generic Pharma Industry

For the US generic drug industry, there are a number of unique challenges, including the following:

  • An unprecedented backlog in application reviews and approvals at FDA's Office of Generic Drugs (OGD).
  • Cutthroat price competition on commodity generics, especially when multiple manufactures are approved on the same day.
  • Continuous price declines for already-marketed products as manufacturers compete on price to obtain or maintain market share.
  • Competition to be first-to-file an Abbreviated New Drug Application (ANDA) containing a patent challenge -- with the potential for 180 days exclusive generic marketing and associated profitability -- has led to ANDAs being filed years in advance of the expiry of other patents not being challenged. For example an ANDA might be submitted challenging a patent which expires in 2025, but agreeing to wait for expiry of the drug substance patent which expires in 2017. Thus the "payoff" of the 180-day generic exclusivity is years away, assuming that exclusivity is not triggered (and lost) in the interim.
  • Authorized "generics" marketed by or on behalf of the innovator firm, greatly reducing the value of 180-day generic exclusivity.
  • OGD's reluctance to approve ANDAs providing for complex drug products -- which might otherwise be profitable due to limited competition. For example, the first two ANDAs for a complex active ingredient drug product were submitted in April 2003 and are still not approved, as OGD continues to request additional data, rather than approve the applications.
  • Anti-generic public relations campaigns, especially for "narrow therapeutic range" drugs or drugs with a pronounced placebo effect (e.g. antidepressants) claiming therapeutic failures after generic substitution. Typically these are attributed to patient or physician advocacy groups, but some allege that their funding is at least in part from the affected innovator pharma companies.

Disclaimer - the above are the author's personal opinions.