Tag: Hatch-Waxman Act

August 13, 2026

30-Month Stay: How Litigation Delays Generic Drug Approval

Explore how the 30-month stay under the Hatch-Waxman Act delays generic drug approval through patent litigation. Learn about Paragraph IV certifications, economic impacts, and upcoming reforms.

July 30, 2026

FDA Therapeutic Equivalency Codes: How Laws Determine Drug Substitutability

Learn how FDA therapeutic equivalency codes determine if generic drugs can substitute brand names. Explore the Orange Book, A vs B ratings, and state laws.

June 18, 2026

How Second and Third Generics Slash Drug Prices

Discover how the entry of second and third generic manufacturers drastically cuts drug prices, breaking brand monopolies and saving consumers billions.

June 13, 2026

Cost Comparison: Authorized Generics vs First-to-File Generics Explained

Compare costs of authorized generics vs first-to-file generics. See how FTC data shows price drops, revenue impacts, and market strategies affect your medication bill.