Related Experiment Video
Updated: Jan 7, 2026
10:49
Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 18, 2013
18.5K
Tertiary Patents on Drugs Approved by the FDA
Theodore W Teng1, S Sean Tu2, Helen Mooney3
1Harvard College, Cambridge, Massachusetts.
JAMA Health Forum
|January 2, 2026
Summary
Drug-device combination manufacturers often use tertiary patents, which protect delivery devices, to extend market exclusivity. A study found that over half of these patents lack active pharmaceutical ingredient claims, potentially delaying generic competition.
Area of Science:
- Pharmaceutical Sciences
- Intellectual Property Law
- Regulatory Affairs
Background:
- Drug-device combinations, like inhalers and injectables, involve complex patenting strategies.
- Manufacturers secure primary (API), secondary (formulation/use), and tertiary (device) patents.
- Concerns exist regarding the improper listing of tertiary patents, potentially hindering generic drug access.
Purpose of the Study:
- To analyze the scope and impact of tertiary patenting on drug-device combinations approved by the Food and Drug Administration (FDA).
- To investigate whether tertiary patents extend market exclusivity beyond primary and secondary patents.
- To assess the prevalence of tertiary patents lacking active pharmaceutical ingredient claims.
Main Methods:
- Retrospective cohort study of patents listed in the FDA's Orange Book for drug-device combinations (1986-2023).
- Patents categorized as primary, secondary, or tertiary.
- Analysis of patent claims, duration of protection, and added exclusivity from tertiary patents.
Main Results:
- Of 331 products with tertiary patents, 54.0% (1751/3241) were tertiary patents.
- 59.8% (1047/1751) of tertiary patents lacked active pharmaceutical ingredient claims.
- Tertiary patents extended protection for 54.4% (180/331) of products, adding a median of 7.5 years.
Conclusions:
- Tertiary patents significantly extend market exclusivity for drug-device combinations.
- A substantial portion of tertiary patents do not claim active pharmaceutical ingredients, raising concerns about delayed generic competition.
- Policymakers and regulators should review Orange Book listings to ensure timely generic access.
Related Concept Videos
01:26FDA Approved Drugs: Changes to Approved Drugs
222
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
222
01:25Drug Regulation
2.7K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
2.7K
01:28Drug Products: Biologics, Biosimilars and Interchangeables
214
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
214
01:11Clinical Trials: Overview
4.5K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.5K
01:17Drug Nomenclature
2.9K
During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
2.9K
01:21Tertiary Healthcare System
2.1K
Specialized care provided over an extended period is called tertiary care. Usually, a primary or secondary care physician will refer a patient to tertiary care. A patient's maximum physical and mental function is restored in tertiary care, which is caused due to the impact of a chronic illness or condition. Tertiary care aims to achieve the highest level of functioning possible while managing chronic illness. For example, a patient who falls and fractures their hip will need secondary care...
2.1K