Skyrizi risankizumab patent expiration date?

What happens when the Skyrizi patent expires?

The Skyrizi patent for risankizumab, developed by AbbVie, is not a traditional small molecule patent like many other medications. Rather, it has a patent for a specific composition of matter and dosage forms, which will expire at different times [1]. As of my knowledge cutoff, the initial composition of matter patent for risankizumab filed by AbbVie is set to expire in 2038.

How long does Skyrizi's exclusivity period last?

The Biologics Price Competition and Innovation Act (BPCIA) provides a 12-year exclusivity period for biologics, plus any additional patents that might protect the product beyond that [2]. For Skyrizi, this means that AbbVie maintains exclusivity on the medication until at least 2036, with the possibility of extending that period.

Can biosimilars enter the market before patent expiry?

Under the BPCIA, biosimilars can be approved and sold six months before the original biologic's patent expires if the applicant provides the necessary notice to the patent holder [3]. This means that biosimilar manufacturers can start preparing for market entry as early as 2037, even before the patent expires in 2038.

Will AbbVie's patent challenges impact Skyrizi's exclusivity?

AbbVie has challenged several patents related to Skyrizi, which could potentially extend the exclusivity period. However, the impact of these challenges on the patent's expiration date is unclear at this time [4].

What's the status of Skyrizi's patents?

AbbVie's Skyrizi patents are a complex web of composition of matter, dosage form, and method of use patents. The company has been active in protecting these patents and has filed multiple oppositions and counterclaims against biosimilar applicants. While some Skyrizi patents have already expired, others are still in force, and new patents have been granted [5].

Sources:

1. https://www.drugpatentwatch.com/
2. Biologics Price Competition and Innovation Act (BPCIA)
3. 35 U.S.C. § 271(e)(6)
4. AbbVie's patent challenges against Skyrizi biosimilars
5. Skyrizi patents listed on DrugPatentWatch.com