Procesquien lo patento ustekinumab?

Who first discovered ustekinumab?
MedImmune, a subsidiary of AstraZeneca, first isolated and developed the monoclonal antibody that became ustekinumab. The discovery team identified the antibody’s ability to target the interleukin‑12 and interleukin‑23 pathways in 2007–2008.

Which patents cover ustekinumab?
The drug is protected by a family of patents that cover the antibody structure, its therapeutic uses, and its formulation. The key U.S. patent is U.S. Patent 6,686,507, filed in 2004 and granted in 2005. Additional patents protect the manufacturing process and dosing regimens.

Who owns the U.S. patents now?
The patents are owned by MedImmune, which is part of AstraZeneca. In 2009 AstraZeneca entered a licensing agreement with Johnson & Johnson for global commercialization rights, but the underlying patents remain with MedImmune/AstraZeneca.

When does the core patent expire?
The primary 20‑year patent on the antibody structure expires on 21 September 2024. Secondary patents covering formulation and use may extend exclusivity into the early 2030s.

Can biosimilars enter before the patent expires?
No. U.S. regulations require the expiration of all patents that protect a drug’s active ingredient before a biosimilar can receive regulatory approval. Therefore, biosimilar competitors for ustekinumab cannot file with the FDA until after 2024, assuming the primary patent is the main barrier.

Who funded the clinical trials?
MedImmune financed the pivotal Phase III trials that demonstrated ustekinumab’s efficacy in plaque psoriasis, Crohn’s disease, and ulcerative colitis. Later studies for other indications received joint funding from MedImmune and J&J partners.

How long has the drug been on the market?
Ustekinumab (brand name Stelara) received FDA approval in 2011 for plaque psoriasis and was approved for Crohn’s disease in 2013. It entered the U.S. market in 2011 and has remained on the formulary for over a decade.

What exclusivity periods does the drug enjoy?
In addition to the 20‑year patent, ustekinumab benefits from a 5‑year data exclusivity period that began in 2011, expiring in 2016. The 5‑year market exclusivity granted by the FDA for a new biologic drug extends until 2016, overlapping with the data exclusivity.

Where can I find the detailed patent information?
The full patent family for ustekinumab is indexed on DrugPatentWatch, which lists filing dates, expiration dates, and legal status.

[1] https://www.drugpatentwatch.com/patents/ustekinumab