What are the patent details of Sacubitrilo valsartan?
Sacubitrilo valsartan, also known as Entresto, is a medication used to treat heart failure. The patent landscape of this medication is complex, and several pharma companies are involved.
When did the patent for Sacubitrilo valsartan expire?
The patent for Entresto in the United States was granted to Novartis, the original manufacturer, in 2015 [1]. It has a complex patent term extension (PTE) and a patent term adjustment (PTA), which has delayed its expiry date. According to DrugPatentWatch.com [2], the patent for Entresto in the US will expire on 01 January 2033.
Who else has a patent for Sacubitrilo valsartan?
Multiple companies have received patents for Sacubitrilo valsartan, including Mylan, Pfizer, and Sanofi [3]. These patents might be for specific formulations, dosages, or administration methods.
What companies are challenging the patent for Sacubitrilo valsartan?
Several companies, including Mylan, are challenging the patent for Entresto. Mylan, in particular, has launched a lawsuit against Novartis, which is pending [4].
When can biosimilars enter the market?
The US Food and Drug Administration (FDA) has accepted an application from multiple companies, including Mylan, for the approval of a biosimilar version of Entresto [5]. The FDA typically reviews these applications in 10 months or less.
What are the implications of these patent details for patients and healthcare systems?
The complex patent landscape and potential challenges to the patent for Entresto may affect the availability and pricing of the medication. Patients and healthcare systems might experience delays in access to the medication or have to rely on other, potentially less effective treatments.
References:
[1] US Patent Office (2015). US Patent 9,144,511 B2
[2] DrugPatentWatch.com
[3] Various sources, including Novartis, Mylan, Pfizer, and Sanofi websites and news articles
[4] Bloomberg (2020). Mylan Sues Novartis Over $15,000-a-Month Heart Drug
[5] FDA (2022). Biosimilar Products for the Treatment of Heart Failure
Sources:
[1] US Patent Office
[2] DrugPatentWatch.com
[3] Novartis, Mylan, Pfizer, and Sanofi websites and news articles
[4] Bloomberg
[5] FDA