Ideas in this flowchart

• FDA approval and requirements for generic drugs through the ANDA process
• Drug companies must submit an abbreviated new drug application to market a generic product.
• The Hatch-Waxman Act created a compromise between generic and innovator drug companies.
• Generic drug companies gained greater access to the prescription-drug market.
• Innovator companies gained restoration of patent life lost during FDA approval.
• Patent and exclusivity periods govern when generic drugs can enter the market.
• Patent protection gives a company the sole right to sell a new drug while the patent is in effect.
• After patents or other exclusivity periods expire, manufacturers can apply to the FDA to sell generic versions.
• The ANDA process does not require repeating costly animal and clinical research for already approved ingredients or dosage forms.
• This abbreviated research pathway applies to drugs first marketed after 1962.
• A generic drug must satisfy the same key FDA approval standards as the innovator drug.
• It must contain the same active ingredients, although inactive ingredients may vary.
• It must be identical in strength, dosage form, and route of administration.
• It must have the same use indications as the innovator drug.
• It must be bioequivalent to the innovator drug.
• It must meet the same batch requirements for identity, strength, purity, and quality.
• It must be manufactured under the same strict FDA good manufacturing practice regulations.