Pharma Patent Cliffby readouts.io
Loss of exclusivity · Oncology

Imbruvica patent expiration

Imbruvica (AbbVie and Johnson & Johnson) is expected to face US generic competition from 2032. A court upheld the key patent in 2021; AbbVie expects no US generic before 30 March 2032, assuming pediatric exclusivity. Sales: AbbVie US $2.0B plus J&J outside the US $2.8B.

US loss of exclusivity
2032Settlement / court date
2025 worldwide sales
$4.9BAbbVie and Johnson & Johnson
Therapeutic area
Oncology
Medicare negotiated price
−38%From 2026, vs list price
US competition from
GenericsUS date shown

What the date means

Imbruvica's US exclusivity date is based on settlement / court date. Litigation settlements or a court ruling fix the earliest US entry date, which makes it one of the firmer dates in this tracker. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.

What past cliffs suggest

Among past small-molecule drugs facing generics: Tecfidera's US sales fell to 21% of their 2019 level in its first full year of generics (2021); Revlimid's US sales fell to 96% of their 2021 level in its first full year of generics (2022) and 57% two years later. Where settlements cap generic volumes, as with Revlimid, the decline is slower. See how past cliffs played out →

Who's lined up to copy Imbruvica

Filed with the FDA A court found AbbVie's patents valid and infringed in 2021, blocking approval of Alvogen and Natco's generic until the last patent expires. AbbVie expects no US generic before 30 March 2032.

Company (product)Stage
Alvogen / NatcoBlocked by court ruling (2021)

Checked September 2026. Sources: AbbVie 8-K, Aug 2021 · AbbVie 10-K 2025

Medicare price negotiation

Imbruvica was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 38% below its list price. That is 6 years before US generics can launch, so Medicare revenue comes under pressure first. The discount is measured against list price, before the rebates drugmakers already pay, and applies to Medicare only, so the revenue impact is smaller than the headline number.

What's at stake for AbbVie and Johnson & Johnson

Imbruvica is 4.7% of AbbVie's 2025 revenue ($2.9B of $61.2B). With Skyrizi and Rinvoq, the drugs tracked here add up to 47% of AbbVie's revenue losing US exclusivity by 2037.

Imbruvica is 3% of Johnson & Johnson's 2025 revenue ($2.8B of $94.2B). With Stelara, Darzalex and Tremfya, the drugs tracked here add up to 30% of Johnson & Johnson's revenue losing US exclusivity by 2032. Total includes MedTech.

Bars show each company's tracked drugs as a share of its total 2025 revenue. Imbruvica is highlighted.

Other blockbusters losing US exclusivity in 2032

Sources

  1. AbbVie 8-K, Aug 2021
  2. AbbVie 10-K 2025
  3. J&J 10-K 2025
  4. CMS: negotiated prices for 2026
See all 45 drugs on the patent cliff →