What is 180-Day Exclusivity in US? The $100 Million Prize for First Generic By PharmaShare Regulatory Team | US FDA Generic Strategy | August 2026 Quick Answer: 180-Day Exclusivity is a 6-month monopoly given by USFDA to the First Company that files an ANDA with Para IV challenge and wins. For those 180 days, FDA … Read more
What is Orange Book & How to Read It? Complete Guide for Generic Pharma By PharmaShare Regulatory Team | US FDA Regulatory | August 2026 Quick Answer: Orange Book is the FDA’s official list of all approved drugs + their patents + exclusivity + generic equivalents. If you work in Regulatory, R&D, IP or Business … Read more
Types of ANDA Filing in the US: Para I, II, III, IV Explained with Examples By PharmaShare Regulatory Team | US FDA Regulatory Affairs | August 2026 Quick Answer: An ANDA can be filed under 4 Paragraph Certifications (I, II, III, IV). Your Para filing decides if you launch immediately, wait for patent expiry, or … Read more
