Risankizumab-RZAA

iStock, Michael Vi The settlement agreement will extend market exclusivity for AbbVie’s JAK inhibitor in the U.S. until 2037—providing pediatric exclusivity is granted. AbbVie has reached a settlement with generic drugmakers, extending the period of exclusivity for its JAK inhibitor Rinvoq to 2037. The deal extends Rinvoq’s exclusivity another four years. In an SEC filing on Thursday, the pharma revealed that it has settled lawsuits with “all” generic manufacturers seeking to bring their copycat versions of Rinvoq into the U.S. If Rinvoq is granted pediatric exclusivity , the regulatory document read, the settlement agreements will keep these generics out of the domestic market until April 2037. AbbVie also indicated that the settlements “are subject to standard acceleration provisions,” referring to the typical clauses that allow generics developers to launch their product ahead of the agreed-upon date if other copycat drugs enter the market. Analysts declared the settlement a positive for AbbVie. Writing to investors on Thursday, Willaim Blair called the agreement a “big win” and “clearly a positive development” for Rinvoq. The firm had previously modeled a “steep drop” in Rinvoq sales after 2033, when core protections were set to expire, but has now adjusted its expectations following the settlement. In its own Thursday note, BMO Capital Markets agreed with this analysis, adding that Rinvoq’s extended exclusivity will have far-reaching implications for AbbVie’s business. “Rinvoq and AbbVie’s greater immunology franchise have been essential in offsetting losses following the Humira 2023 LOE [loss of exclusivity],” the analysts wrote. In the second quarter, Rinvoq earned $2 billion , representing a 41.8% year-on-year increase. Together with the anti-inflammatory antibody Skyrizi—which closed Q2 with a $4.4 billion haul—Rinvoq leads AbbVie’s efforts to shore up its revenues as sales of its mega-blockbuster drug Humira decline. The world’s best-selling drug for six years straight, Humira’s sales have cratered amid the influx of biosimilar and other branded competitors. From a peak of $21 billion in 2022, Humira made just $9 billion last year. Rinvoq has much growth yet ahead as AbbVie continues to test the drug in other indications. In July, for instance, the pharma reported that Rinvoq led to significant improvements in scalp hair loss when used in patients with alopecia areata. Guggenheim analysts at the time called Rinvoq the “dominant JAK inhibitor on the market,” pointing to its “clear advantage over competitors in terms of physician familiarity and patient access.” First approved in 2019, Rinvoq is indicated for several immune-mediated disorders such as atopic dermatitis, rheumatoid arthritis, psoriatic arthritis and inflammatory bowel diseases.

A settlement resolves the lawsuit AbbVie originally filed in late 2023, which accused Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals and Sun Pharmaceuticals of attempting to sidestep dozens of Rinvoq patents. With Rinvoq and its sibling medicine Skyrizi having successfully picked up the sales torch in the wake of Humira’s tumble over the patent cliff, AbbVie is working to cover its legal bases so the immunology duo can make the most of its U.S. market exclusivity.Now, the Chicago pharma has done just that by striking a deal with a slate of generics manufacturers that waylays the entry of Rinvoq generics until well into the next decade.AbbVie has settled with each of the drugmakers that have filed for FDA approval of Rinvoq generics, preventing copycat versions of the drug, which also goes by the name upadacitinib, from entering the U.S. market before April 2037.AbbVie disclosed the settlement in a Sept. 11 filing with the Securities and Exchange Commission.The agreement resolves the lawsuit AbbVie originally filed in late 2023, which accused Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals and Sun Pharmaceuticals of attempting to sidestep dozens of Rinvoq patents through their efforts to advance upadacitinib generics.Rinvoq’s composition of matter patent isn’t slated to expire until 2033 in the U.S., nor is Skyrizi’s, for that matter, according to AbbVie’s 2024 annual report. Meanwhile, the FDA Orange Book lists multiple other Rinvoq patents that provide protection running out to 2038.  AbbVie continues to estimate that Skyrizi and Rinvoq will generate combined sales of $31 billion by 2027. The company in January boosted its original 2027 sales projection for the drugs by $4 billion, citing their successful capture of prescriptions in the U.S. AbbVie has been using the drug duo to recover indications once held by Humira—which started to fall prey to biosimilar competition at the start of 2023—and branch out into new immunology niches as well.In late August, AbbVie served up a second helping of positive phase 3 results for Rinvoq in the follicle-attacking hair-loss disease alopecia areata. With the trial win and another that came earlier in the same month, AbbVie said it was eyeing regulatory submissions in the indication.Rinvoq is doing gangbusters on the sales front, too. Between April and June of this year, the drug grew sales by 42% compared to the same period in 2024, breaching the $2 billion quarterly revenue mark for the first time. AbbVie's share price increased nearly 4% Thursday in the wake of the news. In a note to clients, William Blair analyst Matt Phipps, Ph.D., called it a "positive development" as his firm previously estimated a 2033 loss of exclusivity.AbbVie has suggested that multiple upcoming opportunities for Rinvoq in alopecia, as well as vitiligo, hidradenitis suppurativa and systemic lupus erythematosus, could tack on $2 billion to the drug's peak sales projection."With the extension of four additional years of exclusivity, we assume this number will likely go higher," Phipps wrote.