Question 1

When does a drug go generic?

Accepted Answer

A brand-name small-molecule drug can face generic competition once its FDA Orange Book patents expire and any regulatory exclusivity ends. U.S. utility patents generally last 20 years from their filing date, though pediatric exclusivity can add six months and patent-term extensions can add time for FDA review delays. Once the last relevant patent expires, generic manufacturers that filed an abbreviated new drug application (ANDA) can launch, typically cutting prices 80-90%. Each drug page on PatentCliff lists the real Orange Book patent numbers and their expiration dates so you can see the earliest date generics could enter.

Question 2

Where does this patent data come from?

Accepted Answer

Small-molecule drug patents and their 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. Each patent number links to its full record on Google Patents. Biologics are regulated under a different pathway and are not listed in the Orange Book — for those we point to the FDA Purple Book, which tracks biologic exclusivity and approved biosimilars.

Question 3

Why do some drugs show "biosimilar pathway" instead of patents?

Accepted Answer

Biologics — large, complex molecules like antibodies (e.g. Humira, Keytruda, Dupixent) — are not listed in the FDA Orange Book and do not face conventional generic competition. Instead, follow-on competitors called biosimilars can be approved through the FDA's BPCIA pathway, typically after the reference product's 12-year exclusivity period and the resolution of patent litigation. For biologics, PatentCliff links to the live FDA Purple Book listing so you can see current biosimilar approvals and exclusivity status.

Question 4

What is a patent cliff?

Accepted Answer

A patent cliff occurs when a drug's key patents expire in a short window, exposing a large share of its revenue to generic or biosimilar competition. Blockbuster drugs can generate billions in annual revenue that drops sharply once competitors enter the market after patent expiration. The 2026-2030 period sees an unusually large cluster of expirations across major therapies, which is why investors, generic manufacturers, and healthcare policymakers watch these timelines closely.

Question 5

How accurate are the expiration dates?

Accepted Answer

Expiration dates are taken verbatim from the FDA Orange Book, including any pediatric-exclusivity extensions the Orange Book records. They reflect the patents the drug's sponsor has listed with the FDA. Actual generic entry can still be affected by litigation, settlements, additional exclusivities, or patents not listed in the Orange Book, so treat the earliest listed expiration as the earliest plausible date generics could enter — not a guarantee.

When does each druggo generic?

Going Generic Soonest

Trikafta

Revlimid

Entresto

Eliquis

Imbruvica

Lynparza

Ibrance

Jardiance

Tecfidera

Paxlovid

Pomalyst

Rinvoq

Verzenio

All Tracked Drugs

Avastin

Biktarvy

Cosentyx

Darzalex

Dupixent

Eliquis

Enbrel

Entresto

Eylea

Farxiga

Herceptin

Humira

Ibrance

Imbruvica

Jardiance

Keytruda

Lynparza

Mounjaro

Ocrevus

Opdivo

Ozempic

Paxlovid

Pomalyst

Remicade

Revlimid

Rinvoq

Rituxan

Skyrizi

Stelara

Tagrisso

Taltz

Tecfidera

Tremfya

Trikafta

Trulicity

Verzenio

Vyvanse

Wegovy

Xarelto

Xtandi

Understand the Patent Cliff

The 2026-2030 Patent Cliff Report

When Will Generic Ozempic Be Available?

Patent Cliff 2026: Every Drug

What Is a Patent Cliff?

Biosimilars vs. Generics

What Is the FDA Orange Book?

Frequently Asked Questions

When does a drug go generic?

Where does this patent data come from?

Why do some drugs show "biosimilar pathway" instead of patents?

What is a patent cliff?

How accurate are the expiration dates?

When does each drug
go generic?