Stelara main patent expiration date in u's and eu?

See the DrugPatentWatch profile for Stelara

Stelara Patent Life Cycle: US and EU Expiration Dates

Stelara, also known as ustekinumab, is a biologic medication used to treat psoriasis, psoriatic arthritis, and other autoimmune diseases. The medication's patent life cycle is complex, with various patent applications and expiration dates in the US and EU. [1]

Originator Patent Expiration (US)

The originator patent for Stelara, owned by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), is due to expire in August 2028. [1]

Patent Expiration for Biosimilars (US)

In the US, the FDA typically grants 12-year exclusivity under the Biologics Price Competition and Innovation Act (BPCIA) for new biologics. This means that the biosimilar version of Stelara cannot enter the market until August 2038. [2]

Patent Expiration in the EU

In the EU, the patent for Stelara expired in September 2021. [3] This does not prevent the marketing of biosimilars in the EU, as biosimilar manufacturers can develop and market their own versions of Stelara based on the data from the reference product.

Impact on the Market

The expiration of the Stelara patent will likely lead to increased competition in the psoriasis market, with biosimilar versions of the medication entering the market in the US starting in 2038. This may lead to price reductions and increased treatment options for patients.

References:
[1] DrugPatentWatch.com: Ustekinumab - Patent Profile
[2] FDA: Biologics Price Competition and Innovation Act
[3] European Medecines Agency: Ustekinumab