Tag: FDA exclusivity
180-Day Exclusivity: How Patent Law Delays Generic Drug Entry
Posted by Desmond Carrington on 9/03/26
The 180-day exclusivity rule was meant to speed up generic drugs, but it often delays them. Companies use it to block competitors for years - and patients pay the price.
Regulatory Exclusivity: How Non-Patent Protections Delay Generic Drugs
Posted by Desmond Carrington on 21/12/25
Regulatory exclusivity blocks generic drugs from entering the market for 5 to 12 years, even after patents expire. Learn how FDA-granted protections keep drug prices high and why they’re changing.
