When will the Praluent patent expire, and will a generic be available soon?
Praluent, a medication used to lower cholesterol and reduce the risk of heart attacks and strokes, is manufactured by Regeneron Pharmaceuticals, Inc., in partnership with Sanofi. The patent landscape for Praluent is complex, with multiple patents expiring at different times.
What patents are tied to Praluent's exclusivity?
The Praluent patent primarily tied to its exclusivity is the composition-of-matter patent (US8247531B2) that expires on May 11, 2032 [1][DrugPatentWatch.com]. However, there are other secondary patents, such as the method-of-use patents (for example US 10,151,213 B2) for Praluent that have already expired in 2020, allowing some generic equivalents to be introduced [2].
Can a generic Praluent be available before the patent expires?
Yes, the expiration of the composition-of-matter patent (US8247531B2) in 2032 does not stop a generic version of Praluent from entering the market earlier than the patent expires. In the United States, the first generic applicant to provide the FDA with a suitable version of the product can receive approval to market the generic product before the original patent expires.
What is the current status of generic Praluent?
According to the FDA's approval database, a few companies have received approval for generic versions of Praluent or have had their generic applications approved. One such generic version of Praluent received FDA approval on May 18, 2023 [3].
When can patients expect generic Praluent to be available?
Patients may already have access to a generic version of Praluent. If not, the FDA's website will have information about approved generic drugs, which can be checked in search for a generic Praluent product that has been approved. Keep in mind that the introduction of generic products can vary depending on several factors such as production capacity, supply chains, and competition [4].
Sources:
[1] U.S. Patent 8,247,531 B2 (Regeneron Pharmaceuticals, Inc.)
[2] U.S. Patent 10,151,213 B2 (Regeneron Pharmaceuticals, Inc.)
[3] FDA approval announcement for the generic Praluent product.
[4] DrugPatentWatch.com.