DOSE OF REALITY: JAMA STUDY FINDS DRUG PATENT PORTFOLIOS ON SMALL MOLECULE DRUGS HAVE MORE THAN TRIPLED, DELAYING GENERIC COMPETITION

New Analysis Shows Brand Name Drug Companies Increasingly Rely On Follow-On Patents To Extend Exclusivity And Keep Drug Prices High

In case you missed it, a new study from the Journal of the American Medical Association (JAMA) highlights how brand name drug companies have increasingly built expansive patent portfolios around their products, relying heavily on follow-on patents that can extend market exclusivity and delay competition from more affordable generic alternatives. In other words, these patent thickets increasingly lean on secondary or device patents, disconnected from actual innovation on active ingredients, to extend periods of exclusivity and keep drug prices high.

The researchers examined small-molecule drugs approved by the U.S. Food and Drug Administration (FDA) from 1990 to 2019 to evaluate “how pharmaceutical patent portfolios … have evolved over time.” The analysis looked at changes in the number and types of patents associated with each drug, measured the additional duration of patent exclusivity associated with different patent types and examined how frequently those patents were enforced against generic manufacturers through litigation.

The study distinguishes between “primary patents, which cover their active ingredients,” and “nonprimary patents, which cover other product features,” including formulations, delivery devices and methods of use. The researchers note that nonprimary patents are “frequently granted later in a drug’s development, including in some cases after FDA approval.”

The study found a sharp increase in the number of patents brand name drug companies are building around their products. Among the 1,981 small-molecule drugs examined, manufacturers listed 10,940 patents, with the average number of patents per drug more than tripling from 2.1 in 1990 to 6.9 in 2019. Importantly, that growth was “driven primarily by nonprimary patents,” which increased from an average of 1.2 per drug in 1990 to 5.6 in 2019.

Nonprimary patents accounted for 84 percent of all FDA-listed patents examined and 87 percent of patents litigated against generic manufacturers. Nearly half of all patents examined were issued after FDA approval, and 96 percent of those later-issued patents were nonprimary.

These additional nonprimary patents can keep brand name drugs shielded from competition for far longer periods. The study found that by 2019, later-expiring patents extended market exclusivity by an average of 6.1 years, with a median extension of 4.7 years. Additional nonprimary patents alone extended average patent exclusivity by 5.9 years.

As the researchers explain, brand name drug companies “have increasingly broadened their patent thickets after FDA approval,” typically using nonprimary continuation patents to extend exclusivity. The authors found this has “complicated generic competition, prolonging the duration of high drug prices and reducing patient access to lower-cost medicines.”

The researchers further write that many of these patent portfolios “appear to function less as an incentive for innovation and more as a tool for maximizing revenue.” By delaying access to lower-cost medicines without clear innovation, the authors argue these patents can harm patients by delaying generic competition and limiting access to more affordable alternatives.    

The study also highlights the need for solutions to address excessive and duplicative patenting that delays generic and biosimilar competition. Among the potential reforms, the researchers point to limiting the number of continuation patents brand name drug companies can assert in litigation, specifically citing the bipartisan Eliminating Thickets to Improve Competition (ETHIC) Act.

The ETHIC Act targets abuse of the patent system by cutting down on excessive, duplicative drug patents that Big Pharma uses to extend monopoly pricing. The legislation would streamline patent litigation, safeguard quality patents that improve existing drugs and promote faster market entry of lower-cost generics and biosimilars. Big Pharma’s patent thickets on just five drugs cost more than $16 billion in a single year. 

This latest study builds on mounting evidence that effectively lowering prescription drug prices for patients must mean cracking down on Big Pharma’s anti-competitive tactics, like abuse of the patent system, that extends monopoly pricing and keeps Americans locked into paying the highest drug prices in the world.

Read more on the cost of Big Pharma’s anti-competitive playbook here:

BIG PHARMA’S ANTI-COMPETITIVE TACTICS THAT KEEP PRICES HIGH

• Patent Abuse On Just Four Blockbuster Drugs Cost $3.5 Billion in Two Years: In August 2025, a study published in JAMA Health Forum found that lost competition associated with patent thickets on four widely prescribed brand name drugs cost patients, taxpayers and the U.S. health care system more than $3.5 billion in excess spending over two years.
• Big Pharma’s Patent Thickets On Just Five Drugs Cost Over $16 Billion In a Single Year: A January 2023 report from Matrix Global Advisors quantified the one-year cost of lost savings on five brand name drugs surrounded by extensive patent portfolios at more than $16 billion.
• Targeting Blockbuster Products for Patent Abuse: A May 2022 study published in the Journal of the American Medical Association (JAMA) Health Forum revealed how brand name drug companies target their most profitable products for reformulation to extend monopolies and prohibit generic competition from entering the market.
• Big Pharma Increasingly Utilizing Secondary Patents to Extend Monopoly Pricing: A January 2026 study published in JAMA Health Forum examined 331 drugs with tertiary patents and found manufacturers listed 3,241 patents in FDA’s Orange Book, with more than half covering devices or device-related features and only 4.2 percent covering the active pharmaceutical ingredient.
• Delayed Generic And Biosimilar Competition Costs U.S. Health System Hundreds Of Billions In Excess Spending: An analysis from the Association for Accessible Medicines estimated that accelerating access to generic and biosimilar drugs could generate $422.9 billion in savings through greater competition.

Read the full study in JAMA Health Forum HERE.  

Read more on how Big Pharma games the system to block competition and keep drug prices high HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.