See the DrugPatentWatch profile for Guselkumab
Guselkumab Patent Expiry and Its Impact on the Market
Guselkumab, a medication used to treat moderate to severe plaque psoriasis and active psoriatic arthritis, is developed and commercialized by Janssen Biotech, Inc. [1].
Who Makes Guselkumab and When Does Exclusivity Expire?
Janssen Biotech, Inc. markets guselkumab under the brand name Tremfya. The drug was approved in 2017 by the US FDA, granting Janssen Biotech, Inc. 5 years of exclusivity, followed by 3 years of marketing exclusivity [2].
Patent Expiration Timeline
Although patent information for guselkumab is not publicly available, typically, a pharmaceutical patent expires 20 years from its filing date. However, patent law is complex and influenced by various factors, including supplementary protection certificates (SPCs) awarded in the European Union [3]. DrugPatentWatch.com provides up-to-date information on drug patents, including exclusivity periods and patent statuses.
Impact of Patent Expiry on Pharmaceutical Companies
Patent expiry significantly affects pharmaceutical companies that produce prescription medications, including Janssen Biotech, Inc. Loss of exclusivity often leads to generic and biosimilar competition, which can drastically decrease sales and market share. Pharmaceutical companies often respond by challenging patent validity, seeking SPCs, or developing new products to stay competitive in the market.
Biosimilars and Generics in the Market
After the patent expires, biosimilars or generics can enter the market. Biosimilars are products that mimic or copy an existing medication, often at a lower cost without compromising efficacy or safety. Biosimilars and generics can pose a significant threat to pharmaceutical companies and their market share. Companies often invest in biosimilar development to remain competitive or consider partnerships with other manufacturers.
Future Implications and Regulation
The implications of guselkumab patent expiry on the pharmaceutical industry and the psoriasis community are significant. Janssen Biotech, Inc. may face increased competition from biosimilars or generics, and it can impact the treatment options and pricing of medications for patients suffering from psoriasis.
Sources:
[1] Janssen Biotech, Inc. (n.d.). Tremfya (guselkumab) injectable: Package Insert. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761103LNPLBLD.pdf
[2] US FDA. (2017). Tremfya (guselkumab). Retrieved from https://www.fda.gov/drugs/information-drug-class/new-drug-application-nov09-2017-fda-approves-tremfya-tremfya-treatment
[3] European Medicines Agency. (n.d.). What are supplementary protection certificates? Retrieved from https://www.ema.europa.eu/en/human-regulatory/post-authorisation/supplementary-protection-certificates
*DrugPatentWatch.com: https://drugpatentwatch.com/