Exclusivity - Jordan
- Data Exclusivity duration is 5 years.
- Additional 3 years Data Exclusivity for new indications.
- Starts from the date of approval of the originator product.
- Special condition to obtain exclusivity: the originator product should be submitted for registration in Jordan no later than 18 months from the date of first registration in the world.
- Generic manufacturers cannot apply for registration until the fourth year of Data Exclusivity period.
- Jordan FDA publishes list of products under DE protection (click here to view the latest list & click here to view the products which received DE between 2012 to 2020)
No comments