A generic drug can only enter the market after the Patents and Exclusivities of the original drug expire. In 2026, the industry is navigating a major "Patent Cliff," where several high-value biologic and specialty drugs are losing protection.

• Patent Duration: Most drug patents last for 20 years from the date of filing.

• First-to-File Incentives: In the U.S., the first company to successfully challenge a patent or file a generic application often receives 180 days of generic exclusivity, during which no other generic versions can be sold.

• 2026 Watchlist: Notable first-generic approvals in late 2025 and early 2026 include treatments for multiple sclerosis (Cladribine), type 2 diabetes (Sitagliptin/Metformin), and various oncology medications.