Why some generics have only one maker

FDA's June 2026 list of off-patent, off-exclusivity drugs without an approved generic¹ runs to 807 prescription products, by GxRadar's count of the agency's spreadsheet². Every one is a brand-name product whose patents and exclusivities have lapsed. For none of them has FDA approved a generic that references it.

Those products sit at the far end of a wider pattern. Many off-patent drugs do have generics, but only one or two companies making them, and federal and academic studies have tied that thin competition to higher prices and to shortages.

FDA's list of drugs nobody has copied

FDA announced its Drug Competition Action Plan⁴ in 2017 to encourage generic competition and make generic review more efficient. The same year it began publishing this list. The first edition, in June 2017³, said its aim was to encourage generic applications "in markets with no competition." FDA now updates it every six months, in June and December, and since December 2021 has published separate prescription and over-the-counter versions.

Each list has two parts. Part I holds products for which FDA could accept a generic application right away. Part II holds products where development or approval "may raise potential legal, regulatory, or scientific issues," such as a missing product-specific guidance or a complex mixture, and FDA asks sponsors to contact it first. The first edition also left off brand products approved within the past year, since it was too soon to tell whether generic makers would apply. An appendix records products dropped since the last edition because a generic was approved.

GxRadar counted the rows in FDA's spreadsheet. Seven ingredient names appear in both parts, so the total is smaller than the sum. Injectables account for 360 of the 807 product entries, or 45 percent. Many Part II items are the hard-to-copy products described in Complex generics. Congress added a separate incentive in 2017 for drugs with little generic competition, the competitive generic therapy designation.

How many makers a typical drug has

Counting manufacturers takes sales data, and the federal studies that have done it agree that single-supplier markets are common. A December 2023 report⁵ from the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) counted companies with sales of each active ingredient in 2022.

That 43 percent includes brand drugs still under patent, which have one maker by design, so it overstates the problem for generics. ASPE also found the share of small-molecule drugs with a single manufacturer declined from 2017 to 2022, while the share with six or more rose.

Studies limited to generics find a similar shape. A 2017 National Bureau of Economic Research working paper⁶ that defined a market as one molecule in one dosage form found that about 40 percent of generic markets from 2004 to 2016 were supplied by one manufacturer, with a median of about two. The share supplied by one or two companies grew over time and was higher for non-oral drugs. FDA's 2019 shortage report cited the paper, which was not peer-reviewed. ASPE's January 2025 brief⁷ on generic entry found that 60 percent of the drugs it studied were in small markets of fewer than 5,000 users a month, averaging about three labelers per drug, against close to 10 in the largest markets. For injectables, ASPE's December 2024 analysis⁸ counted an average of five manufacturers per molecule in July 2024, compared with nine for oral generics, one reason sterile injectables dominate shortage lists.

What GxRadar's ANDA count shows, and what it can't

GxRadar keeps its own tally from FDA's Drugs@FDA database via openFDA⁹, current through October 27, 2026. It holds 19,593 original approvals of abbreviated new drug applications (ANDAs) across 1,463 distinct active-ingredient combinations. For each combination we counted the ANDAs that still list at least one product as prescription or over-the-counter, which in FDA's data means it has not been moved to discontinued status.

Each drug page shows the number of approved applications on record along with price history. Approval counts are not counts of manufacturers or of supply, and they say nothing about future prices.

These are counts of approvals. They are not counts of manufacturers, and the two can differ a lot. An approved ANDA is permission to sell, and nothing requires the holder to make the drug. FDA's 2019 shortage report¹⁰ found that just before a shortage, the drugs it studied had on average three companies approved to market them that were not doing so. One company can also hold several ANDAs for the same ingredient, for different dosage forms or strengths or through acquisitions. Our ingredient grouping lumps tablets together with injections, and FDA's marketing-status flags can lag behind what is actually shipping. Some single-ANDA entries are recent first generics that other companies may soon join. Year-by-year approval totals are on the approvals page.

Why makers stay away

Most generic markets are small. FDA's 2019 report, summarizing the NBER research, said median quarterly sales for a generic molecule in one dosage form were just over $300,000 in the third quarter of 2016. Prices also fall as competitors arrive. ASPE's 2025 brief⁷ found prices about 20 percent below the pre-generic level in markets with about three competitors, and 70 to 80 percent lower in markets with 10 or more, three years after first generic entry; why generic prices fall as competitors enter walks through that curve. For a later entrant into a small market, the math means splitting modest revenue at a falling price.

Entry still costs real money. A 2021 cost study prepared for ASPE¹² estimated that even a simple immediate-release tablet that qualifies for a waiver of human bioequivalence testing takes about $2.4 million in direct development spending, or about $5.3 million once the risk of failure and the cost of capital over roughly five years are included. Complex products cost far more. The same study estimated that the existence of an FDA product-specific guidance alone cuts a developer's expected costs by 22.3 percent, or $25.9 million, on average. The full cost picture is in The economics of making a generic.

A 2017 study in the Annals of Internal Medicine¹¹ looked at competition and price. It followed 1,120 generic drugs through commercial claims from 2008 to 2013. After adjustment, drugs that began the period with monopoly-level competition were associated with a 47.4 percent price increase over the study period, and near-monopolies with a 20.1 percent increase. Drugs with duopoly-level competition saw an 11.8 percent decline, and those with about four competitors fell 31.7 percent. Several of the largest jumps of that era are described in The generic price spikes of 2013 to 2015.

FDA's next off-patent list¹ is due in December 2026. Its appendix will show which of the 807 products picked up a first generic in the past six months.