30 March 2032
Earliest US generic Imbruvica, per AbbVie
After a 2021 court ruling and settlements, assuming pediatric exclusivity. Hetero already has FDA approval.
When does Imbruvica go off patent?
In the US, generics can launch from 2032. Imbruvica is sold by AbbVie and Johnson & Johnson. A court upheld the key patent in 2021; AbbVie expects no US generic before 30 March 2032, assuming pediatric exclusivity. Sales: AbbVie in the US ($2.05B) plus J&J outside the US ($1.93B). The revenue each company reports also includes its share of the other's profit, so the two add up to more.
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.
| Patent or protection | Covers | Expiry |
|---|---|---|
| US 8,008,309 | Ibrutinib itself, with pediatric exclusivity | 13 May 2028 |
| Method-of-treatment patents | Uses of ibrutinib, with pediatric exclusivity | 3 December 2031 |
| 2021 court ruling and settlements | Earliest US generic entry, per AbbVie, assuming pediatric exclusivity | 30 March 2032 |
| Later patents | Drug forms, tablets and other formulations | 14 June 2039 |
| FDA orphan exclusivity | One approved use | 24 August 2029 |
Ibrutinib's compound patent runs to November 2027, or May 2028 with pediatric exclusivity, but AbbVie expects no US generic before 30 March 2032. That date comes from a 2021 court ruling against Alvogen and Natco and settlements with the other filers. The FDA gave Hetero final approval in September 2026, which does not change the date by itself. Later formulation patents run to 2039. J&J sells Imbruvica outside the US.
Sources: FDA Orange Book data files · AbbVie 8-K, Aug 2021 · AbbVie 10-K 2025
| Year | AbbVie (US) plus J&J (outside the US) | US | Growth |
|---|---|---|---|
| 2021 | $6.94B | $4.32B | – |
| 2022 | $5.82B | $3.43B | -16% |
| 2023 | $4.88B | $2.67B | -16% |
| 2024 | $4.47B | $2.45B | -8% |
| 2025 | $3.98B | $2.05B | -11% |
US is AbbVie's US net revenue; the rest is J&J's sales outside the US. Each company's share of the other's profit is left out. Net sales as reported, with the US share. Sources: AbbVie 10-K 2025 · AbbVie 10-K 2023 · J&J 10-K 2025 · J&J 10-K 2023
Approved, waiting to launch The FDA gave Hetero final approval for generic Imbruvica capsules in September 2026. AbbVie still expects no US generic before 30 March 2032, after a 2021 court ruling against Alvogen and Natco and settlements with other filers.
| Company (product) | Stage |
|---|---|
| Hetero | 140 mg capsules: FDA-approved 8 Sep 2026 |
| Alvogen / Natco | Filed with the FDA; court ruled for the brand 2021 |
| Zydus | Capsules: FDA-approved 31 Mar 2021, not marketed |
Checked October 2026. Sources: FDA Orange Book: Hetero · AbbVie 8-K, Aug 2021 · AbbVie 10-K 2025
Among past small-molecule drugs facing unrestricted generics, US sales in the first full year after copies arrived were a median 18% of the last full year before (range 0% to 48%, 10 drugs), and 6% by the third year (8 drugs). Where settlements limit generic volumes, as with Revlimid, the decline is slower. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →
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. See every negotiated Medicare price →
Imbruvica is 4.7% of AbbVie's 2025 revenue ($2.9B of $61.2B). With Vraylar, Venclexta, Skyrizi and Rinvoq, the drugs tracked here add up to 57% 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, Xarelto, Simponi, Opsumit, Darzalex, Tremfya, Invega Sustenna and Erleada, the drugs tracked here add up to 46% of Johnson & Johnson's revenue losing US exclusivity by 2033. Total includes MedTech.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Imbruvica is highlighted.
After a 2021 court ruling and settlements, assuming pediatric exclusivity. Hetero already has FDA approval.
Hetero's capsules are approved, but AbbVie still expects no US generic before 30 March 2032. FDA Orange Book