What is the difference between FDA patents and FDA exclusivity?

A patent is issued by the USPTO and can cover composition, formulation, or methods of use. FDA exclusivity, by contrast, is granted upon drug approval and prevents generic competition for a defined period.

How long do FDA patents last?

Most patents last 20 years from the filing date, though effective market life may be shorter due to lengthy FDA approval times. Extensions may apply in limited cases.

What role does the FDA Orange Book play?

The Orange Book lists approved drugs along with their patent numbers, expiration dates, and exclusivity details, helping competitors know when generics may be filed.

Can a patent expire before FDA approval?

Yes. Patents may be granted or expire before a drug is FDA-approved. However, exclusivity only begins once FDA approval is secured.

What is patent evergreening?

Evergreening refers to filing additional patents for minor modifications to extend exclusivity periods, delaying generic competition and often leading to higher consumer costs.

FDA Patents and Drug Exclusivity Explained

Learn how FDA patents and drug exclusivity work, including pros, cons, the Orange Book, and strategies like evergreening that affect generic competition 4 min read updated on August 18, 2025

Key Takeaways

FDA patents are tied to drug approval and regulated by both U.S. patent law and FDA exclusivity provisions.
Pros include protecting investments, encouraging innovation, and allowing market exclusivity for new drugs.
Cons include long timelines, high costs, and the risk of rejection despite significant investment.
Exclusivity vs. patents: patents are granted by the USPTO, while exclusivity is granted by the FDA upon drug approval.
The Orange Book is the FDA’s database of approved drugs with therapeutic equivalence, listing patents and exclusivity periods.
Special protections like pediatric exclusivity, orphan drug exclusivity, and the Hatch-Waxman Act create additional incentives or extensions.
Patent

FDA Patents

FDA patents are granted by the United States Patent and Trademark Office at any time during the drug's development. New pharmaceutical products are governed in the United States by U.S. Food and Drug Administration law and U.S. patent law.

FDA Patents and Drug Exclusivity

While patents are issued by the U.S. Patent and Trademark Office (USPTO), the FDA plays a crucial role in regulating drug exclusivity once a product is approved. Exclusivity provides manufacturers with exclusive marketing rights for a set period, separate from patent protection. This balance ensures companies can recoup research and development costs while eventually allowing generic competition.

FDA exclusivity types include:

New Chemical Entity (NCE) Exclusivity – 5 years.
Orphan Drug Exclusivity – 7 years for rare disease treatments.
Other Exclusivity – 3 years for new clinical investigations.
Pediatric Exclusivity – 6-month extension added to existing protection.
Generic Drug (ANDA) Exclusivity – 180 days for first generic applicants.

Pros Associated with FDA Patents

While the FDA may be criticized for being too strict in approving drugs when safety issues are involved, the agency can adjust the rules if it deems a change is necessary.
If a company's new drug is approved and granted exclusivity, this can help promote and balance marketing between a new drug entering the market and its generic competition.
Getting an FDA patent is a necessity for companies with products to market, as it is illegal to sell drugs that do not have the FDA's stamp of approval.

Role of the Orange Book

The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, lists all approved prescription drugs and details their patent and exclusivity protections. It serves as a reference for healthcare professionals, generic drug manufacturers, and attorneys evaluating when a generic can enter the market. For each drug, the Orange Book provides:

Patent numbers and expiration dates.
Exclusivity periods granted by the FDA.
Information on therapeutic equivalents to guide substitution.

By consulting the Orange Book, competitors can determine the earliest possible date to file for approval of a generic version of a branded drug.

Cons Associated with FDA Patents

Three reasons drug development fails are the approval process the drug must pass, the length of time it takes to get through the approval process, which can be 10 years or more, and development costs that are in the billions of dollars.
Additional reasons for drug failure include extensive and complex drug trials, post-approval trials by the FDA, determining and analyzing side effects caused by the drug, and the research involved in how the drug is to be administered.
FDA patents are not necessarily easy to have approved due to changing regulations.
Even when a company is confident all the necessary data is compiled for the FDA, the agency can require more information or that more studies be conducted.
Competitors and newcomers to the drug market may be discouraged and not participate in new drug development due to the high cost involved and risk in creating a product that may never be approved.

Common Challenges and Patent Strategies

A major criticism of FDA patents and exclusivity provisions is patent “evergreening.” This occurs when drug makers file additional patents on small modifications—such as delivery methods, formulations, or combinations—to extend market exclusivity well beyond the original patent term. Critics argue this practice can delay generic entry and keep drug prices high.

Other challenges include:

Patent litigation delays: Generic manufacturers often face lawsuits if they challenge listed patents.
Regulatory uncertainty: FDA requirements may change, leading to delays or additional costs.
High barriers for entry: Smaller firms may lack the resources to compete with established pharmaceutical companies.

Despite these challenges, FDA patents remain essential to incentivizing pharmaceutical innovation and ensuring safety and efficacy in drug development.

Frequently Asked Questions

What is the difference between FDA patents and FDA exclusivity? A patent is issued by the USPTO and can cover composition, formulation, or methods of use. FDA exclusivity, by contrast, is granted upon drug approval and prevents generic competition for a defined period.
How long do FDA patents last? Most patents last 20 years from the filing date, though effective market life may be shorter due to lengthy FDA approval times. Extensions may apply in limited cases.
What role does the FDA Orange Book play? The Orange Book lists approved drugs along with their patent numbers, expiration dates, and exclusivity details, helping competitors know when generics may be filed.
Can a patent expire before FDA approval? Yes. Patents may be granted or expire before a drug is FDA-approved. However, exclusivity only begins once FDA approval is secured.
What is patent evergreening? Evergreening refers to filing additional patents for minor modifications to extend exclusivity periods, delaying generic competition and often leading to higher consumer costs.

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