April 2037
Settlements allow US generic Rinvoq
AbbVie settled with every generic filer in September 2025, assuming pediatric exclusivity.
When does Rinvoq go off patent?
In the US, generics can launch from 2037. Rinvoq is sold by AbbVie. September 2025 settlements bar US generics before April 2037. Consensus had assumed 2032.
Rinvoq'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 RE47,221 | Upadacitinib itself (composition of matter) | 16 August 2033 |
| US 8,962,629 | Upadacitinib (drug substance) and approved uses | 15 January 2031 |
| Settlements with every generic filer | Earliest US generic entry, assuming pediatric exclusivity | April 2037 |
| 41 patents on crystal forms, the tablet and uses | The drug substance form, tablets and uses | 17 October 2036 |
| FDA orphan exclusivity | One approved use | 28 April 2032 |
AbbVie expects the US composition-of-matter patents to expire in 2033, but in September 2025 it settled with every generic filer, and expects no US generic before April 2037, assuming pediatric exclusivity is granted. The settlements have standard acceleration clauses. More than 40 later patents on crystal forms, the tablet and uses run to October 2036, and two use patents to March 2038.
Sources: FDA Orange Book data files · AbbVie 10-K 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | $3.97B | $2.82B | – |
| 2024 | $5.97B | $4.26B | +50% |
| 2025 | $8.30B | $5.94B | +39% |
Worldwide net sales as reported, with the US share. Source: AbbVie 10-K 2025
Filed with the FDA AbbVie settled with every generic filer in September 2025. No US generic is expected before April 2037, assuming pediatric exclusivity.
| Company (product) | Stage |
|---|---|
| Sandoz | Filed with the FDA; settled Sep 2025; US entry allowed from Apr 2037. Assuming pediatric exclusivity is granted |
| Hetero | Filed with the FDA; settled Sep 2025; US entry allowed from Apr 2037. Assuming pediatric exclusivity is granted |
| Aurobindo | Filed with the FDA; settled Sep 2025; US entry allowed from Apr 2037. Assuming pediatric exclusivity is granted |
| Intas | Filed with the FDA; settled Sep 2025; US entry allowed from Apr 2037. Assuming pediatric exclusivity is granted |
| Sun Pharma | Filed with the FDA; settled Sep 2025; US entry allowed from Apr 2037. Assuming pediatric exclusivity is granted |
Checked October 2026. Sources: AbbVie 10-K 2025 · Fierce Pharma
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 →
Rinvoq is 14% of AbbVie's 2025 revenue ($8.3B of $61.2B). With Vraylar, Imbruvica, Venclexta and Skyrizi, the drugs tracked here add up to 57% of AbbVie's revenue losing US exclusivity by 2037.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Rinvoq is highlighted.
AbbVie settled with every generic filer in September 2025, assuming pediatric exclusivity.
AbbVie settled with every generic filer. Analysts had modeled US exclusivity ending in 2032. Fierce Pharma