Tertiary Patents on Drugs Approved by the FDA.

ABSTRACT:

Importance

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.

Objective

To analyze patent protection on small-molecule

SUBMITTER: Teng TW 

PROVIDER: S-EPMC12761334 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature