Generic drug approval: A US perspective

Abstract

Objective:

Generic drugs are identical or bioequivalent versions of the brand name drugs. They are the economic alternative of the costlier brand name drugs. This article presents a general overview of the procedure and regulatory aspects relating to generic drug approval in the US.

Methods:

A computerized search was conducted to find literature on generic drug approval in the US. The literature was searched using the following key words: generic drug, brand name drug, Hatch–Waxman Act, Medicare Act, NDA, ANDA, CTD and exclusivity.

Findings:

The search results were filtered for the literature describing and analyzing the procedure and regulatory provisions for generic drug approval in the US. After the screening total 19 applicable literature remained.

Conclusion:

In the US standardized procedures for the recognition of generic drugs have been laid down under the Drug Price Competition and Patent Term Restoration Act, 1984 (the Hatch–Waxman Act). Provisions of this Act such as patent challenge, patent term extension and data exclusivity have created profound effects on the approval, sale and distribution of the pharmaceuticals in the US. The Hatch–Waxman Act is an excellent piece of legislation that takes care of the rights of both the brand name and generic drug companies. This article presents only an overview of generic drug approvals and for all practical purposes official resources should be referred.

Key words::

• Brand name drug
• Generic drug
• Hatch
• Waxman Act
• Patent
• US FDA