FDA's list of off-patent drugs that still have no generic

In June 2026, FDA counted 365 brand-name prescription drug applications that had run out of patents, run out of marketing exclusivity and still had no approved generic copy. They make up Part I of the agency's prescription List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic², the products for which FDA says it "could immediately accept an ANDA without prior discussion." Another 78 applications sat in Part II, which FDA reserves for products where generic development "may raise potential legal, regulatory, or scientific issues."

The list has appeared every June and December since its first edition in June 2017⁷. It is one of the few places where FDA says, product by product, where generic competition is legally possible but has not arrived. GxRadar downloaded the spreadsheet behind each edition to see how the counts have moved.

This piece explains how FDA builds the list, what the June 2026 edition contains, how it ties into the agency's tools for speeding generic reviews, and what the list cannot tell you.

How FDA builds the list

Everything starts with the Orange Book. The June 2026 edition was built from FDA's Orange Book data files⁸ as accessed on April 10, 2026, according to the methodology printed at the end of the list. A product makes the list when four things are true: at least one approved, active brand application (an NDA) exists for it; that application is marketed as a prescription product; no generic application (an ANDA) has been approved for it; and no unexpired patent or exclusivity is listed for it in the Orange Book.

Products approved within the past year are left out, because FDA says it is "generally too soon" for a generic to have been approved. Products whose only applications are discontinued are also left out, as are products that have an approved but discontinued generic.

FDA has tightened the rules over time. Its first list in 2017 was organized by active ingredient. In December 2017, FDA switched to individual drug products. In December 2021, it split the list into separate prescription and over-the-counter versions¹. And in June 2025⁶ it began listing each strength separately, so an application now appears if any one of its strengths lacks an approved generic.

That last change explains why familiar names turn up. The June 2026 Part I includes two strengths of one levothyroxine application and one strength each of two chlorthalidone applications, even though generic versions of both ingredients are widely sold. The list tracks a specific application, dosage form and strength, which is narrower than an ingredient.

What the June 2026 edition contains

By GxRadar's count of the June 2026 prescription spreadsheet³, Part I has 699 rows covering 365 distinct applications and 246 distinct ingredient entries. Part II has 108 rows covering 78 applications. The appendix, which records products that left the list because a generic was approved since the prior edition, has five rows covering four applications: bortezomib powder for injection, a citalopram capsule, a fluticasone propionate inhaler and an extended-release mesalamine capsule.

Injectables and solutions dominate what remains.

Counts are distinct applications by the first word of FDA's dosage-form label, from GxRadar's tally of the June 2026 file. An application with more than one dosage form is counted once per form.

On Part I, the oral tablets and capsules lean toward rare-disease and tropical-medicine drugs (benznidazole, miltefosine, triclabendazole), older cancer drugs (busulfan, chlorambucil, thioguanine) and a handful of extended-release versions of common molecules. Part I also includes several skin patches, among them nitroglycerin and selegiline, and dry-powder inhalers of albuterol and budesonide. Part II holds metered-dose inhalers of albuterol, levalbuterol and fluticasone with salmeterol. Those categories are the subject of GxRadar's explainers on generic inhalers and generic skin patches.

A separate June 2026 over-the-counter list⁴ is much shorter. GxRadar counted 33 applications in Part I and 18 in Part II.

Nineteen editions, by the numbers

Comparing editions takes care, because each methodology change altered what gets counted. Counting distinct applications rather than rows gives the most consistent series.

Source: GxRadar count of distinct NDA numbers in each edition's spreadsheet on FDA's list page¹. Selected editions shown.

Two patterns stand out. Part II has shrunk from more than 200 applications in 2017 and 2018 to 78. And the appendices add up. Across the 17 editions from June 2018 through June 2026, GxRadar counted 203 distinct applications that left the list because FDA approved a generic. The December 2025 edition⁵ alone moved 35.

An appendix entry means a generic was approved. It does not show that the generic launched, or that its price fell.

What the list is used for

FDA started the list in 2017, the same year it announced its Drug Competition Action Plan⁹ to speed generic competition. Its stated purpose, repeated on every edition, is to "improve transparency and encourage the development and submission of ANDAs in markets with little competition."

It also lines up with FDA's review-priority rules. The agency's manual for prioritizing generic applications, MAPP 5240.3¹⁰, names as one priority factor any drug product with "not more than three approved drug products" in the Orange Book and "no blocking patents or exclusivities." A product on Part I, with only its brand approved and nothing blocking, falls inside that description. GxRadar's companion piece on how FDA prioritizes generic applications covers the other factors.

A second tool came from Congress. The FDA Reauthorization Act of 2017 created the competitive generic therapy designation for drugs with "inadequate generic competition," which 21 U.S.C. 356h¹¹ defines as no more than one approved drug in the Orange Book's active section. FDA's CGT guidance¹² says the designation can bring expedited development and review, and the first approved applicant can earn 180 days of exclusivity. FDA keeps a running list of CGT approvals¹³.

Part II steers some products to a different door. The list notes that for some Part II products "submission and/or approval of an ANDA via the 505(j) pathway may not be appropriate" and that the 505(b)(2) pathway may fit. In August 2026, FDA issued a draft guidance on choosing between an ANDA and a 505(b)(2) application¹⁴.

FDA's own research makes the economic case. The agency's generic competition and drug prices¹⁵ studies report that "market entry of just a few generic competitors" yields generic prices below the brand price, a pattern GxRadar has traced in its own price data.

What the list does not tell you

A listed drug is not necessarily hard to get. Every product on the list has an active brand application, which in Orange Book terms means it is not marked as discontinued, and the list says nothing about supply. For that, FDA's shortage list is the place to look. Nor does a listing say whether anyone is developing a generic.

Some products stay on the list for years because the market is small. GxRadar's piece on why some generics have only one maker describes the same economics one step later, after a first generic arrives. Others stay because the science is hard, which is why complex products fill so much of Part II.

FDA asks for suggestions on the methodology and on products to add, at genericdrugs@fda.hhs.gov. The next edition is due in December 2026, and GxRadar's generic approvals tracker will show which of the 365 Part I applications pick up a generic in the meantime.