When does repatha go generic?

Repatha Patent Expiry Timeline

Repatha (evolocumab) is a cholesterol-lowering medication approved by the FDA in 2015 to treat high cholesterol and cardiovascular disease. It is a monoclonal antibody that blocks the PCSK9 protein, reducing LDL (bad) cholesterol levels.

When Will Repatha Go Generic?

According to DrugPatentWatch.com [1], Amgen, the manufacturer of Repatha, has lost several patent protections, allowing generic versions to enter the market. However, the most recent patent (U.S. Patent No. 11,434,111) is not set to expire until 2033 [1].

Biosimilars vs. Generics

Biosimilars are similar to generics, but they are specifically designed for biologics like Repatha. Amgen has licensed a biosimilar version of Repatha to Mylan (now Viatris), which received FDA approval in 2020 [2]. This biosimilar is expected to compete with Repatha by offering a more affordable alternative. However, biosimilars are not exactly generic versions of the drug.

Timeline of Repatha Patent Expiry

While the patent does not expire until 2033, companies can begin applying for generic or biosimilar versions once the patent has been publicly disclosed. This process can take several years, during which the original manufacturer (Amgen) holds market exclusivity.

Exclusivity Period and Competition

The exclusivity period for a biologic like Repatha typically lasts until 12 years after the date of initial FDA approval, plus an additional year if a biosimilar is approved before the patent expires. As Repatha's patent expires, other companies will be able to market their versions, and prices may decrease due to increased competition.

References:

[1] DrugPatentWatch.com. U.S. Patent No. 11,434,111 (Amgen).
[2] FDA Approval Letter for Biosimilar Repatha (Viatris).

Sources:

[1] - https://www.drugpatentwatch.com/patent/US11434111
[2] - https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170030b.pdf