Length of Drug Patents

The cost of developing a new drug in the U.S. may range from $800 million to $2 billion.

The Center for Drug Evaluation and Research (CDER), administered under the U.S. Food and Drug Administration (FDA), works to ensure that drugs made available to the public are safe and effective. Companies issuing a new drug are responsible for testing and submitting evidence of the drug's safety to the CDER. During this initial development process, the company usually applies for a patent.

Patent

Obtaining a patent for a new drug typically begins once it is in development and is issued for 20 years. This grants the company enough time to bring the drug to market which can take several years, leaving sufficient time for profitability and recovery of costs.

Process

Drug patents are designed to ensure that enough time is given to the company developing the new drug to research and test it without competing companies infringing on the process. Patents help protect a company's business interest as they make an investment in the costly process of bringing medicines to market.

Expiration

When a patent for a drug is about to expire, other companies may apply through the FDA to sell the drug. These generic drugs must meet the same specifications as the original and may cost less for the consumer because the cost to bring it to market was absorbed by the original patent holder.

References

• Food and Drug Administration: Frequently Asked Questions on Patents and Exclusivity
• United States Patent and Trademark Office: Patents
• U.S. General Services Administration: Generic Drugs

Resources

• America.gov: The Cost of Developing a New Drug