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505(b)(2) Patent & Marketing Exclusivity

IP attorney Stephen Albainy-Jenai and I just concluded a webinar hosted by DIA entitled 505(b)(2) Patent & Exclusivity.  23 different companies attended, showing the increasing interest in 505(b)(2) issues.  Earlier this year, DIA hosted my overview of the 505(b)(2) drug development process where the attendees had many questions asking specifically about patents and exclusivity, many of which I couldn’t answer because of time and scope of the topic.

In this webinar we distinguished and explained two concepts: patents and marketing exclusivity.

  • Patents are issued by the US Patent and Trade Office based on intellectual property.  A patent lasts for 20 years yet, can be challenged and found invalid.
  • Marketing Exclusivity is granted by FDA as an incentive to conduct studies.  The term ranges from 3-7 years and can be extended by 6 months in some cases by pediatric studies.  Exclusivity cannot be challenged or taken away.  Drug sponsors like this certainty!

Specifically, the marketing exclusivity terms are:

Marketing Exclusivity Terms



3 Years Clinical studies essential for approval
5 Years New Chemical Entity (NCE) – usually, older drugs never approved
7 Years Orphan Drugs
6 months Pediatric – an extension to an existing exclusivity or patent

The term “clinical studies” is defined in the regulations as any clinical study other than bioavailability.  This same regulation defines ‘essential for approval’ as “there are no other data available that could support approval of the application”.  See this link for the Orphan Drug exclusivity regulation.

Marketing Exclusivity means that a generic cannot be marketed during the applicable term.  Moreover, for 3-year exclusivity, an generic cannot be approved until the 3 years expires, while for 5-year exclusivity a generic application cannot be filed until the 5 years expired ( 4 years if a generic uses a Paragraph IV challenge).

Importantly, there are 505(b)(2) applications that receive no exclusivity – those applications that did not need to conduct a clinical study.  These drugs are approved on the basis of only bioavailability studies.  An example that receives no exclusivity would be developing an extended release oral product when the reference listed drug (RLD) is an immediate release drug product.

Generally, you find out what exclusivity you might get at the pre-IND meeting.  But the FDA only determines exclusivity at the time of approval.