AbbVie hits out at proposed Rinvoq generics

22 Nov 2023
firstwordpharma.com
Drug ApprovalPatent InfringementBiosimilar
AbbVie has filed litigation against several manufactures that are seeking FDA approval for generic versions of its immunosuppressant drug Rinvoq (upadacitinib). According to a 136-count complaint filed this week in the US District Court for the District of Delaware, AbbVie alleges that the companies' proposed generic versions of the oral JAK inhibitor infringe combinations of over two dozen patents.
At the company's earnings call in October, CEO Rick Gonzalez indicated that Rinvoq and another of AbbVie's immunology medicines, Skyrizi (risankizumab), are considered "significant" future growth drivers for the company, which is facing sharp drop-offs in sales of Humira (adalimumab) after competing biosimilars entered the US market earlier this year.
Five generic drugmakers targeted
AbbVie's patent infringement lawsuit is against drugmakers Aurobindo, Hetero Labs, Intas Pharmaceuticals, Sandoz and Sun Pharmaceuticals, and their subsidiaries. In its complaint, AbbVie says it invested more than $3 billion in developing its "ground-breaking" once-daily oral JAK inhibitor, which is approved in the US for seven immune-mediated diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, atopic dermatitis, ulcerative colitis and most recently Crohn's disease.
The lawsuit argues that if the FDA approves the various applications for generic Rinvoq, the manufacture and sale of the drugs would infringe combinations of 34 Rinvoq patents. According to the FDA's Orange Book, patents on the drug do not expire for several years, the first starting at the end of 2030.
AbbVie recently reported that Rinvoq sales were up nearly 60% in the third quarter to reach $1.1 billion, while Skyrizi brought in $2.1 billion. Chief commercial officer Jeff Stewart estimated that both drugs were on pace to log a combined $11.6 billion in sales this year.
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