Tag: authorized generics

Pharmacy

180-Day Exclusivity and Authorized Generics: Legal Considerations in U.S. Drug Markets

The 180-day exclusivity rule was meant to reward generic drug companies for challenging patents - but authorized generics let brand-name makers undercut them. This legal loophole is changing how drugs reach patients and who profits.

Pharmacy

Recent Authorized Generic Approvals: Current Options and Market Trends

Authorized generics are identical to brand-name drugs but sold under different labels. As of 2025, only 12 new ones were approved, down from 37 in 2022. Learn which are available, why they're rare now, and how they compare to traditional generics and biosimilars.