AbbVie Settles Rinvoq Litigation

 

“AbbVie has struck a deal with generic drugmakers aimed at extending patent protection for its blockbuster autoimmune drug Rinvoq [1] well into the next decade.

 

AbbVie on Thursday said it has settled litigation with all generic manufacturers that have filed applications with the Food and Drug Administration for generic versions of Rinvoq, which is approved for use in several autoimmune diseases.

 

The North Chicago, Ill., biopharmaceutical company said it now doesn't expect any U.S. generic entry for Rinvoq prior to April 2037, given the settlement and license agreements and assuming the company wins pediatric exclusivity.

 

Analysts at William Blair, who had previously assumed a 2033 loss of U.S. patent exclusivity for Rinvoq, said the settlements are a big win for AbbVie that support longer-term protection for the franchise.

 

William Blair had previously assumed a Rinvoq patent expiration in 2033 in the U.S. and 2034 in the EU, and the analysts had modeled a steep drop in Rinvoq sales starting in 2033, dropping from a peak of $18 billion in 2032 to $1 billion by 2035.

 

With the settlements, the analysts said they now expect peak worldwide Rinvoq sales of $19 billion in 2033 and peak U.S. Rinvoq sales of $15 billion in 2036.

 

AbbVie is leaning on sales of Rinvoq and fellow autoimmune drug Skyrizi to overcome lost sales from its mega-blockbuster Humira, which was once the world's bestselling drug and generated more than $21 billion in sales in 2022, the last year before it lost patent protection.

 

AbbVie earlier this year said it expects combined Skyrizi and Rinvoq revenue will top $31 billion in 2027, including Skyrizi revenue of more than $20 billion and Rinvoq revenue of more than $11 billion.

 

The company recently reported positive data from a pair of Phase 3 studies of Rinvoq in alopecia areata, a disease that causes sudden hair loss, and plans to seek regulatory approval.

 

William Blair noted that AbbVie is due to unveil several more Phase 3 Rinvoq readouts, including in vitiligo in 2025 and in hidradenitis suppurativa and systemic lupus erythematosus next year, and that AbbVie has previously indicated that the next wave of Rinvoq approvals could add about $2 billion to peak-year sales for the drug.

 

AbbVie shares were recently up 4.1% to $220.22 after touching a record high of $221.77 earlier in the session, pushing the company's market capitalization up to around $389 billion.” [2]

 

1. Rinvoq (upadacitinib) is a prescription medicine used to treat several inflammatory conditions in adults and children. It is a Janus kinase (JAK) inhibitor that works by calming the immune system to reduce inflammation.

Rinvoq is typically prescribed when a person has not responded adequately to other medications, such as tumor necrosis factor (TNF) blockers. It is available as an extended-release tablet and an oral solution.

Uses

Rinvoq is FDA-approved to treat the following conditions:

 

    Rheumatoid arthritis (RA): In adults with moderate to severe RA.

    Psoriatic arthritis (PsA): In adults and children ages 2 and older.

    Atopic dermatitis (eczema): In adults and children ages 12 and older with moderate to severe eczema.

    Ulcerative colitis (UC): In adults with moderate to severe UC.

    Crohn's disease (CD): In adults with moderate to severe CD.

    Ankylosing spondylitis (AS): A form of arthritis affecting the spine, in adults.

    Non-radiographic axial spondyloarthritis (nr-axSpA): A type of inflammatory arthritis affecting the spine, in adults.

    Polyarticular juvenile idiopathic arthritis (pJIA): In children ages 2 and older.

    Giant cell arteritis (GCA): A condition involving inflammation of the arteries in the head, in adults.

 

Boxed warnings

Rinvoq has boxed warnings from the FDA regarding an increased risk of several serious conditions. A boxed warning is the most serious type issued by the FDA. Potential risks include:

 

    Serious infections: The drug suppresses the immune system, increasing the risk of serious and even fatal infections, such as tuberculosis.

    Increased death rate: There is an increased risk of death in people age 50 or older with at least one cardiovascular risk factor.

    Cancer and immune system problems: The risk of certain cancers, including lymphoma and lung cancer, is increased. Current or past smokers are at a higher risk.

    Cardiovascular events: A higher risk of major cardiovascular events like heart attack and stroke has been observed, particularly in older adults with cardiovascular risk factors who are current or past smokers.

    Blood clots: There is an increased risk of blood clots in the legs or lungs.

 

Common side effects

Common side effects of Rinvoq include:

 

    Infections of the nose and throat (upper respiratory tract infections)

    Nausea

    Acne

    Headache

    Stomach pain

    Cough

    Fever

    Increased levels of cholesterol

 

Who should not take Rinvoq

Your doctor may not recommend Rinvoq if you:

 

    Have an active infection.

    Have very low levels of lymphocytes, neutrophils, or hemoglobin.

    Are allergic to upadacitinib or any of its ingredients.

    Are currently taking other JAK inhibitors or potent immunosuppressants.

 

1. AbbVie Settles Rinvoq Litigation. Kellaher, Colin.  Wall Street Journal, Eastern edition; New York, N.Y.. 12 Sep 2025: B2.