The term of a prescription drug’s patent is 20 years from the date of a pharmaceutical company’s patent application. Therefore, a generic drug can only be marketed after the brand name drug's patent has expired. A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage, safety, strength, quality and performance. Generic drugs are usually much cheaper than brand name drugs once they reach the market. However, large pharmaceutical companies often pay generic drug makers to delay marketing a generic version of their drug to keep the price of the original medication high. Critics claim this “pay for delay” tactic benefits both brand name and generic drug makers, but is bad for consumers who foot the bill for more than $1 billion in higher drug prices each year. Pharmaceutical companies warn that generic drugs, some foreign-made, may lack the quality assured to consumers by FDA-approved medications. However, researchers who purchased foreign-made pharmaceuticals online and compared them to FDA-approved drugs found these drugs proved to be safe and effective medications.

Proposed legislation: reintroduction of S.142 - Preserve Access to Affordable Generics and Biosimilars Acy (118th Congress (2023-2024)
Prospective Sponsor: Sen. Amy Klobuchar (MN)