Exclusivity

Understanding Patent Length and Generic Competition in Pharmaceuticals

Understanding Patent Length and Generic Competition in Pharmaceuticals

Hello everyone! I’ve been preparing to share more insights on pharmaceutical regulations in the future, and today I’ve learned about patents, FDA approvals, and how generics enter the market. How Patent Protection Works Patent Duration FDA Approval Time What Happens After the Patent Expires? Generic Drug Applications Market Exclusivity for ... Read More
Patents and Exclusivities | Differences and Importance

Patents and Exclusivities | Differences and Importance

FDA

Patents Property right issued by USPTO to an inventor “to exclude others from making, using, sale, import the invention into the US for a period of 20 years from the date of filing”. Patents can be issued or expire at any time regardless of the drug’s approval status Patent information ... Read More
Patents and Exclusivity in Pharmaceutical Industry

Patents and Exclusivity in Pharmaceutical Industry

Did you know that “patent” and “exclusivity” are two of the most commonly searched terms on the FDA website? Generics account for more than 80% of prescription drugs in the US, and that number continues to grow. With approaching patent expirations of several top selling prescription brand-name drugs, sponsors of ... Read More