
AbbVie has taken legal action against several generic drug manufacturers in an effort to safeguard its highly profitable immunology drug, Rinvoq. The lawsuit, filed in a Delaware federal court, accuses Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals, and Sun Pharmaceutical of attempting to circumvent numerous patents protecting Rinvoq for the next decade. Rinvoq, along with its counterpart Skyrizi, is crucial for AbbVie as it anticipates countering the sales decline of Humira due to the introduction of biosimilars.
Last year, AbbVie’s CEO, Rick Gonzalez, expressed confidence that Rinvoq and Skyrizi could surpass the peak revenues achieved by Humira. Rinvoq received its seventh FDA approval in early 2023 as a treatment for Crohn’s disease, adding to its existing approvals for conditions such as rheumatoid and psoriatic arthritis, dermatitis, ankylosing spondylitis, and axial spondyloarthritis. The drug’s global sales reached $1.11 billion in the third quarter of the previous year, contributing to a total of $2.52 billion in sales for 2022. Remarkably, in the first nine months of 2023 alone, Rinvoq surpassed the previous year’s sales, reaching $2.71 billion.
As Humira faces a decline in sales due to patent expiration, AbbVie is intensifying its promotion of Rinvoq. However, there is a considerable timeframe before the company needs to address the impact of generic competition. The U.S. composition of matter patent covering upadacitinib (Rinvoq) is not set to expire until 2033, according to AbbVie’s annual filing. Other sources, including the FDA Orange Book, indicate patents protecting Rinvoq until March 2038.
Despite the anticipated arrival of Rinvoq generics being at least a decade away, AbbVie recognizes the potential for adjustments to this timeline due to regulatory or legal challenges. Seeking to maintain exclusivity, AbbVie is requesting an injunction to prevent Sandoz and other generic manufacturers from marketing their products before Rinvoq loses exclusivity. Additionally, the company is pursuing damages if these generics are sold or commercially manufactured prior to the expiration of multiple patents.
In terms of Humira, AbbVie has experienced better-than-expected revenue retention this year, competing effectively with biosimilar alternatives. In July, the company revised its 2023 prediction for Humira sales erosion to 35%, down from the initial estimate of 37%.