Tag: Hatch-Waxman Act

Patent Litigation and Authorized Generics: How They Shape Drug Competition

Explore how authorized generics impact pharmaceutical competition, disrupt the Hatch-Waxman exclusivity period, and influence patent litigation outcomes.

Pharmacy Reimbursement Models: How Laws Shape Generic Drug Payments

Explore how US laws and reimbursement models like Medicare Part D influence generic drug pricing. Learn about PBMs, MAC pricing, and upcoming policy changes affecting pharmacy costs.

180-Day Exclusivity and Authorized Generics: Legal Considerations Explained

The 180-day exclusivity rule was meant to reward generic drugmakers for challenging patents-but brand-name companies can legally launch their own versions during that time, undercutting profits and weakening competition. Here's how it works, why it's controversial, and what’s being done to fix it.