Tertiary Patents on Drugs Approved by the FDA

TL;DR

This study finds that patents on drug delivery devices can significantly extend market exclusivity for drug-device combinations, potentially delaying generic competition.

Contribution

The study quantifies the extent to which tertiary patents on delivery devices extend patent protection for drug-device combinations.

Findings

Tertiary patents extended protection for 54.4% of drug-device products by a median of 7.5 years.

Over half of tertiary patents did not mention active pharmaceutical ingredients in their claims.

The median duration of expected patent protection for these products was 17.6 years.

Abstract

How have medical device patents contributed to periods of market exclusivity on drug-device combinations?

In this cohort study of 331 drug-device combinations approved by the Food and Drug Administration (FDA) from 1986 to 2023, 1751 of 3241 individual patent listings were on the delivery devices of these products. Medical device patents extended periods of protection for 180 products (54.4%) by a median (IQR) of 7.5 (2.8-13.9) years, with most device patents failing to mention the active pharmaceutical ingredients in their claims.

Patenting strategies on drug-device combinations may impede generic entry and keep prices high for patients and payers.

This cohort study analyzes patent protection on small-molecule drugs approved by the US Food and Drug Administration from 1986 to 2023 with 1 or more tertiary patents.

Manufacturers of drug-device combinations, such as inhalers and injectable medications, often obtain patents not just on the active pharmaceutical ingredients of these products (primary patents) but also on other features, such as their formulations and methods of use (secondary patents) and delivery devices (tertiary patents). Courts, policymakers, and regulators have recently begun scrutinizing whether manufacturers may be improperly listing tertiary patents with the Food and Drug Administration (FDA) that lack claims on active pharmaceutical ingredients and whether such patents may be delaying generic competition. However, the full scope of patenting practices on drug-device combinations remains unknown.

To analyze patent protection on small-molecule drugs approved by the FDA from 1986 to 2023 with 1 or more tertiary patents.

In this retrospective cohort study of patenting practices on drug-device combinations, all patents listed in the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book) were categorized (primary, secondary, or tertiary), and products with at least 1 tertiary patent were included. Analyses were performed between May 2024 and October 2025.

The primary outcome of the study was the duration of expected patent protection on each product, measured from the time of approval until expiration of the last-to-expire patent. Added protection from tertiary patents that went beyond protection afforded by primary or secondary patents was also analyzed.

The FDA approved 331 products from 1986 to 2023 with 1 or more tertiary patents; 137 of 3241 patents (4.2%) listed on these products were primary patents, 1353 of 3241 were secondary patents (41.7%), and 1751 of 3241 were tertiary patents (54.0%). Among tertiary patents, 1047 of 1751 (59.8%) lacked claims making any mention of active pharmaceutical ingredients. The median (IQR) duration of expected patent protection among products in the cohort was 17.6 (14.4-21.2) years. There were 180 products (54.4%) that had tertiary patents extending periods of expected protection beyond other patents, and the median (IQR) duration of added protection was 7.5 (2.8-13.9) years.

The findings of this cohort study suggest that policymakers and regulators should take steps to ensure that tertiary patents are not improperly listed in the Orange Book and that generic competition occurs in a timely fashion.

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