Tag: Hatch-Waxman Act
Antitrust Issues in Generic Substitution: Legal Concerns and Enforcement
Explore how pharmaceutical companies use product hopping and REMS abuse to block generic substitution, violating antitrust laws. Learn about key court cases like NY v. Actavis and the FTC's enforcement actions.
Generic Drug Availability: From Patent Expiration to Market Launch
Explore the complex journey of generic drug availability from patent expiration to market launch. Learn about the Hatch-Waxman Act, ANDA process, patent thickets, and why delays occur despite legal expirations.
Patent Litigation: How Authorized Generics Undermine Generic Drug Competition
Authorized generics let brand-name drug makers launch their own cheap versions during the first generic’s exclusivity period, crushing real competition and keeping prices high. Here’s how it works-and why it’s hurting patients.