Orange Book – 21 Exclusivity codes with Definitions
This article contains information of orange book exclusivity codes with there definition.
Orange Book – 21 Exclusivity codes with Definitions
What is mean by Exclusivity?
Exclusivity is a time period when a brand-name drug is safeguarded from generic drug competition. Different types of exclusivities are established for different scenarios. It’s aim to maintain a balance between new drug innovation and generic drug competition.
What is mean by Exclusivity Code in Orange Book ?
A code assigned by FDA to identify the exclusivity granted to a drug product.
Table I : Exclusivity codes with definitions used in orange book
Significance of Exclusivity in the Pharmaceutical Industry
Exclusivity is an important aspect of the pharmaceutical industry because it allows drug manufacturers to recover their investments in research and development, Clinical trials. It also encourages the development of new drugs by providing a time period during which the manufacturer has exclusive rights to market the drug. This encourage innovation and allows for the development of new treatments for diseases and conditions.
However, exclusivity can also lead to higher drug prices, as the manufacturer has no competition during the exclusivity period. This can make drugs less accessible to patients who cannot afford them.
Note : There are also some of the exclusivity codes are available in orange book with numbers, that codes also assigned/Granted by FDA as per drug category.
To Read in Detail on Exclusivity Codes with Numbers and Without numbers and its Definitions as per Orange Book plz click on the below links.
https://www.accessdata.fda.gov/scripts/cder/ob/results_exclusivity.cfm
