Patents & exclusivity of Drug Products in US Market

Patents & Exclusivity of Drug Products in US Market

Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. In other words exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to new drug application (NDA) or abbreviated new drug application holder if statutory requirements are met. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.

Patent terms are set by statute.  Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States.  Many other factors can affect the duration of a patent.

Patents and exclusivity apply to drugs in different ways.  Patents can be issued or expire at any time regardless of the drug’s approval status.  Exclusivity attaches upon approval of a drug product if the statutory requirements are met.  Some drugs have both patent and exclusivity protection while others has just one or neither.  Patents and exclusivity may or may not run concurrently and may or may not cover the same aspects of the drug product.

Type of Exclusivity	Tenure
Orphan Drug Exclusivity (ODE)	7 years
New Chemical Entity Exclusivity (NCE)	5 years
Generating Antibiotic Incentives Now (GAIN) Exclusivity	5 years added to certain exclusivities
New Clinical Investigation Exclusivity	3 years
Pediatric Exclusivity (PED)	6 months added to existing Patents/Exclusivity
Patent Challenge (PC)	180 days (this exclusivity is for ANDAs only)
Competitive Generic Therapy (CGT)	180 days (this exclusivity is for ANDAs only)