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505(b)(2) – Freedom from Generic Competition – Exclusivity Issues

Well, freedom from generic competition for a while at least.  Generally, most companies business plans specify some means to keep the competition at bay until the product can make a profit : when revenues start to exceed investments.

There are two ways for 505(b)(2) applications to obtain a market free from a duplicate: patent protection and exclusivity.

Patent protection stems from being able to obtain a patent from the U.S. Patent and Trademark Office. The patent could cover the indication, the formulation or synthesis.  This patent can potentially block the approval of a generic version.
Exclusivity is granted by the FDA under 21 CFR 314.108.  The periods of exclusivity are:

  • 3 years: clinical studies essential for approval
  • 5 years: NCE — old drugs never approved under an NDA
  • 7 years: Orphan Drug
  • 6 months: pediatric studies (added on to existing exclusivity or patent life)

I’m going to focus on exclusivity.  Let’s start with the fact that if your drug product does not require a clinical study for approval you obtain no exclusivity for your drug product.  Unless you have a good patent, no exclusivity means that a generic can be approved as soon as it can be made, shown bioequivalent and winds it way through the Office of Generic Drugs; you’ll likely get at least 2 years on the market without generic competition.

What does it mean ‘clinical study’?  Recall that all drug products approved in the US must meet the same standards — the NDA standard, containing all studies to show safety and efficacy.  Applications differ on where the information comes from — ANDA’s get their information from the reference listed drug (RLD) as long as there is no difference from the RLD.  505(b)(2)’s get their information from an RLD plus information to show that differences do not affect safety and efficacy.  This information comes from either public domain or studies conducted by the applicant.  These studies can include pre-clinical (non-human) or clinical studies.  For purposes of exclusivity, phase 1 and phase 2a studies usually do not count as clinical studies (they are usually conducted in a healthy population).  Thus, phase 2b and phase 3 studies count as clinical studies for the purposes of determining exclusivity.  There is a certain risk here, because FDA does not make the determination of whether a clinical study was required for approval until the time of approval.

Thus, if a clinical study is required for approval and the applicant has conducted it, then the minimum exclusivity is 3 years from the date of approval.  As shown above, 5 or 7 years can be obtained under the listed conditions.

See FDA FAQ’s on Patents and Exclusvity for other comments.