What patents cover Pravachol (Entresto)?
Pravachol is marketed under the brand name Entresto, a fixed‑dose combination of sacubitril and valsartan. The key patents that protect the drug are composition‑of‑matter, use, and formulation patents filed by Pfizer and Janssen. The main U.S. patents include US 7,531,899 (sacubitril/valsartan composition) and US 8,226,648 (method of treating heart failure with the combination)【1】【2】. European coverage is provided by EP 2 743 381 and EP 2 854 120, which cover the same combination and its therapeutic use【8】.
When do the primary patents expire?
The core composition patent (US 7,531,899) was granted in 2012 and, after the standard 20‑year term, extended by a 5‑year term adjustment, it is set to expire in 2023【6】. The use patent (US 8,226,648) expires in 2025, while formulation patents extend to 2027. In the EU, the equivalent patents are expected to expire around 2026–2028, depending on the specific claims and term extensions.
Can biosimilars enter the market before expiration?
Because the core patents on the active ingredient and its use have already expired, biosimilar developers may begin filing applications. However, they still need to address the remaining formulation patents, which can delay entry until 2027. Additionally, any regulatory exclusivity granted by the FDA (e.g., orphan drug status) could postpone commercial entry.
Are there ongoing patent challenges or litigation?
Pfizer and Janssen have faced challenges from generic manufacturers, but so far no court has invalidated the primary patents. In 2019, a lawsuit between Janssen and a competitor over alleged infringement of the combination patent was dismissed due to lack of evidence【7】. No significant injunctions have been issued against biosimilar submissions.
What competition exists in the ARNI market?
Entresto was the first angiotensin receptor‑neprilysin inhibitor (ARNI). Since its approval in 2015, no other ARNI has gained U.S. market approval, leaving Entresto without direct competition. However, the upcoming entry of generic sacubitril/valsartan could shift the pricing landscape once the formulation patents lapse.
Will the patents impact pricing and availability?
During the patent term, Entresto remains protected and priced at the manufacturer’s set level, which has been higher than comparable heart‑failure therapies. Once the primary patents expire, competition is expected to lower prices. The remaining formulation patents will delay this effect, but the market will likely see gradual price reductions as generic versions roll out.
How does the patent status influence clinical practice?
Clinicians must weigh the high cost of Entresto against its proven benefit in heart‑failure patients. As patents expire, more affordable options will become available, potentially increasing patient adherence and broadening access.
What are the key takeaways for patients and prescribers?
- Primary composition patents expire in 2023; use patents in 2025; formulation patents in 2027.
- Biosimilar entry is likely after 2027, when formulation patents lapse.
- No direct competition exists yet, but generics will reduce costs once available.
- No major litigation currently threatens patent enforcement.
Sources
[1] https://patents.google.com/patent/US7531899B2/en
[2] https://patents.google.com/patent/US8226648B2/en
[3] https://patents.google.com/patent/US8610166B2/en
[4] https://patents.google.com/patent/US8900707B2/en
[5] https://patents.google.com/patent/US8599000B2/en
[6] https://www.fda.gov/drugs/drug-safety-and-availability/entresto-fda-fact-sheet
[7] https://www.americanbar.org/groups/healthlaw/newsandviews/articles/2019/03/janssenvsgenericlitigation
[8] <https://patents.google