Annual Report
The Drug Patent Cliff Report 2026-2030
15 brand-name drugs see their earliest patent expire in the next five years — plus 19 biologics facing biosimilar competition.
FDA Orange Book data, updated June 2026
Executive Summary
The 2026-2030 window is one of the most consequential drug patent cliff periods in recent memory. Across the 40 blockbuster brand-name drugs tracked here, 15 small molecules have their earliest FDA Orange Book patent expiring in this five-year span, opening the door to generic competition that typically cuts prices 80-95% within two years.
The nearest expirations include Ozempic (semaglutide), Wegovy (semaglutide (weight)), Farxiga (dapagliflozin). Each drug page lists the real Orange Book patent numbers and expiration dates so you can see the earliest date a generic could plausibly launch.
A separate dynamic governs biologics — 19 of the drugs here, including Humira, Keytruda, and Dupixent. Biologics are not listed in the Orange Book and don't get conventional generics; instead, biosimilars are approved through the FDA's BPCIA pathway after the reference product's exclusivity and patent litigation resolve. For those, we link to the live FDA Purple Book.
Small-Molecule Expirations by Year
Counts drugs whose earliest Orange Book patent expires that year; later patents may extend protection on some formulations.
Drugs Losing Protection Soonest
| Drug | Generic Name | OB Patents | Earliest Expiration |
|---|---|---|---|
| Ozempic | semaglutide | 33 | 2026 |
| Wegovy | semaglutide (weight) | 17 | 2026 |
| Farxiga | dapagliflozin | 17 | 2026 |
| Xtandi | enzalutamide | 7 | 2026 |
| Trikafta | elexacaftor/tezacaftor/ivacaftor | 60 | 2027 |
| Revlimid | lenalidomide | 2 | 2027 |
| Entresto | sacubitril/valsartan | 6 | 2027 |
| Eliquis | apixaban | 2 | 2027 |
| Imbruvica | ibrutinib | 44 | 2027 |
| Lynparza | olaparib | 12 | 2027 |
| Ibrance | palbociclib | 3 | 2027 |
| Jardiance | empagliflozin | 15 | 2027 |
| Tecfidera | dimethyl fumarate | 9 | 2028 |
| Paxlovid | nirmatrelvir/ritonavir | 22 | 2028 |
| Pomalyst | pomalidomide | 3 | 2030 |
Biologics: The Biosimilar Track
These 19 drugs are biologics — no Orange Book patents and no conventional generics. Biosimilar competition follows the FDA’s BPCIA pathway. Each links to its live FDA Purple Book listing.
Methodology
Small-molecule patent numbers and expiration dates come directly from the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), the official FDA listing of patents associated with approved drug products — 321 listed patents across these 40 drugs. Biologics, which the Orange Book does not cover, are linked to the FDA Purple Book. See our full methodology.
Cite This Report
PatentCliff. "The Drug Patent Cliff Report 2026-2030." patentcliff.org. https://www.patentcliff.org/report/patent-cliff-2026-2030
Frequently Asked Questions
Of the 40 brand-name drugs PatentCliff tracks, 15 small-molecule drugs have their earliest FDA Orange Book patent expiring between 2026 and 2030. A further 19 are biologics, which don't face conventional generics — biosimilar competition follows the FDA's BPCIA pathway instead.
The nearest small-molecule expirations include Ozempic (semaglutide), Wegovy (semaglutide (weight)), Farxiga (dapagliflozin), Xtandi (enzalutamide), Trikafta (elexacaftor/tezacaftor/ivacaftor). Once the relevant Orange Book patents expire and exclusivity ends, generic manufacturers can launch — typically cutting prices 80-95%.
Biologics are not listed in the FDA Orange Book and do not get conventional generics. Instead, biosimilars can be approved through the BPCIA pathway, typically after the reference product's 12-year exclusivity and the resolution of patent litigation. PatentCliff links each biologic to its live FDA Purple Book listing for current biosimilar status.
Small-molecule expiration dates are taken verbatim from the FDA Orange Book, including pediatric-exclusivity extensions. They reflect the patents the drug sponsor listed with the FDA. Actual generic entry can still be affected by litigation, settlements, or unlisted patents, so treat the earliest listed date as the earliest plausible generic entry.
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