Authorized generic

Authorized Generic

An authorized generic is a pharmaceutical product that is produced by the brand-name drug manufacturer and marketed under its chemical name without the brand name on its label. This type of generic drug is identical to the branded product in terms of dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

Overview

Authorized generics are typically introduced into the market by the original brand-name manufacturer, often through a subsidiary or a licensing agreement with another company. This strategy is used to compete with other generic manufacturers that enter the market after the expiration of the brand-name drug's patent.

Regulatory Aspects

Authorized generics are approved by the Food and Drug Administration (FDA) in the United States under the original New Drug Application (NDA) of the brand-name drug. Unlike other generic drugs, which require an Abbreviated New Drug Application (ANDA), authorized generics do not need to undergo additional approval processes because they are considered the same as the brand-name product.

Market Impact

The introduction of an authorized generic can significantly impact the market dynamics for a particular drug. By offering a lower-cost alternative to the brand-name drug, authorized generics can capture a portion of the market share that would otherwise go to other generic manufacturers. This can lead to reduced prices and increased competition in the pharmaceutical market.

Benefits and Criticisms

Authorized generics can provide benefits to consumers by offering lower-cost alternatives to brand-name drugs while maintaining the same quality and efficacy. However, they have also been criticized for potentially undermining the incentives for other generic manufacturers to enter the market, as the presence of an authorized generic can reduce the profitability of launching a new generic version.

Examples

Several well-known drugs have been marketed as authorized generics, including Lipitor (atorvastatin), Plavix (clopidogrel), and Crestor (rosuvastatin). These authorized generics have been introduced to maintain market presence and competitiveness after the expiration of the original patents.

Also see

• Generic drug
• Brand-name drug
• Pharmaceutical patent
• Drug pricing
• FDA approval process