Tag: Hatch-Waxman Act

Explore the legal clash between 180-day generic exclusivity and authorized generics. Learn how brand-name drugs bypass regulations, impacting market share and patent litigation strategies in the US pharma industry.

Discover how pharmaceutical companies use regulatory exclusivity and patent stacking to extend monopolies beyond standard patent terms, delaying generic entry.

Authorized generics and first-to-file generics both lower drug costs, but authorized generics drive prices down further by adding competition during the first-filer's exclusivity period - saving patients and insurers millions.