Tag: Hatch-Waxman Act

By Harriet Calvington
5 Comments

FDA Orange Book: Where to Find Patent Expiration Dates for Generic Drugs

The FDA Orange Book is the official source for patent expiration dates of brand-name drugs in the U.S. Learn how to find and interpret these dates to predict when generic versions will become available.

29 Jan

By Harriet Calvington
13 Comments

How Multiple Generic Drug Competitors Enter After the First Market Entrant

After the first generic drug enters the market, a cascade of competitors follows-triggering steep price drops, manufacturing challenges, and corporate tactics like authorized generics and PBM deals. Here’s how the race really unfolds.

5 Dec

By Harriet Calvington
15 Comments

Paragraph IV Patent Challenges: How Generic Drug Makers Beat Brand Patents

Paragraph IV patent challenges let generic drug makers legally fight brand drug patents before they expire. This system, created by the Hatch-Waxman Act, saves consumers billions and drives 90% of U.S. prescriptions to generics.

19 Nov

By Harriet Calvington
12 Comments

When Do Drug Patents Expire? Understanding the 20-Year Term and Real-World Timeline

Drug patents are often said to last 20 years, but in reality, most drugs have only 7-12 years of market exclusivity due to lengthy approval times. Learn how patent extensions, regulatory exclusivity, and layered protections affect when generics become available.

13 Nov

By Harriet Calvington
15 Comments

Patent Litigation: How Authorized Generics Undermine Generic Drug Competition

Authorized generics let brand drugmakers launch identical copies of their own drugs during the first generic's exclusivity period, crushing competition and keeping prices high. Here's how it works and why it's under fire.