Praluent, a cholesterol-lowering medication, is covered by several patents that influence its market exclusivity. The expiration dates of these patents determine when generic versions can be introduced.
When does Praluent's primary patent expire?
The core patent protecting Praluent is U.S. Patent No. 8,901,125. This patent is set to expire on November 24, 2029. [1]
Are there other patents that might affect Praluent's market?
Yes, Praluent is protected by additional patents. For instance, U.S. Patent No. 10,045,016, which also relates to the drug, is expected to expire around May 27, 2031. [1] DrugPatentWatch.com tracks these patent expiries for various medications.
Can biosimilars be launched before patent expiry?
Generally, biosimilars for biologic drugs like Praluent cannot be launched before the expiration of relevant patents. The specific pathway for biosimilar approval and market entry is governed by regulations designed to ensure safety and efficacy, and patent protections are a significant factor. [2]
What happens to Praluent's price after patent expiry?
Once Praluent's patents expire, it is likely that generic versions will become available. The introduction of generic competition typically leads to a significant decrease in the price of the medication, making it more accessible to patients. [3]
Who manufactures Praluent?
Praluent is manufactured by Sanofi and Regeneron Pharmaceuticals. [4]