Tag: generic drugs

Secondary Patents: How Pharmaceutical Brands Extend Market Exclusivity

Secondary Patents: How Pharmaceutical Brands Extend Market Exclusivity

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Secondary patents allow drug companies to extend market exclusivity beyond the original patent. Learn how these legal tools delay generic competition, impact drug prices, and spark industry debates.

Foreign Manufacturing of Generics: FDA Oversight and Standards in 2026

Foreign Manufacturing of Generics: FDA Oversight and Standards in 2026

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The FDA now conducts unannounced inspections of foreign generic drug factories to ensure safety. With 90% of U.S. generics made overseas, stricter oversight is critical. Learn how CGMP standards, new inspection rules, and global reforms are changing drug safety in 2026.

Therapeutic Equivalence Codes: How the FDA Determines Which Generic Drugs Can Be Substituted

Therapeutic Equivalence Codes: How the FDA Determines Which Generic Drugs Can Be Substituted

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Learn how the FDA uses therapeutic equivalence codes to determine which generic drugs can be safely substituted for brand-name medications. Understand AB and B codes, the Orange Book, and what this means for your prescriptions.