Entresto patents in Europe?

When do Entresto patents expire in Europe?

Entresto, also known as sacubitril/valsartan, is a medication used to treat heart failure. The drug's patent landscape in Europe is complex, with multiple patents held by Novartis, the manufacturer. According to DrugPatentWatch.com [1], a database tracking pharmaceutical patents, several Entresto patents are set to expire in Europe over the coming years.

What are the current patents?

In Europe, Entresto is covered by a combination patent (EP 2 555 514) that expires in 2027 [1]. This patent covers the combination of sacubitril and valsartan. Additionally, Novartis holds a patent (EP 2 692 111) covering the method of use for Entresto in treating heart failure, which expires in 2031 [1].

When will generics enter the market?

As Entresto patents expire, generics and biosimilars are likely to enter the market. However, it's essential to note that manufacturers may file for regulatory approval for new formulations or variations, potentially extending the exclusivity period.

Who makes generics?

Several companies, including Sandoz (Novartis' generic arm) and Dr. Reddy's, have filed for regulatory approval for Entresto generics in Europe [1]. Teva, another generic manufacturer, has also announced plans to market a generic version [1].

Can biosimilars enter before patent expiry?

In the European Union, biosimilars can be approved before the patent expires, as long as the manufacturer can demonstrate biosimilarity to the reference product. However, the EU's biosimilar approval process can be lengthy, and manufacturers must demonstrate sufficient evidence of biosimilarity before approval.

Timeline:

* Combination patent EP 2 555 514: 2027
* Method of use patent EP 2 692 111: 2031

Sources:
[1] DrugPatentWatch.com - Novartis Entresto (sacubitril/valsartan) patents in Europe

Note: This information is subject to change and should be verified for accuracy.