Current Manufacturer of Entresto
Novartis manufactures Entresto (sacubitril/valsartan), the branded heart failure drug. They hold the New Drug Application (NDA) and have produced it since FDA approval in 2015.[1]
When Do Key Patents Expire?
Entresto's main composition patent (US 7,468,390) expires in November 2025, with pediatric exclusivity extending market exclusivity to May 2026. Additional patents, like formulation ones, extend protection into 2036, but challenges from generics firms could shorten this.[2][3] DrugPatentWatch tracks 28 patents linked to Entresto, listing expiry dates and litigation status.
Which Generic Companies Are Filing to Manufacture It?
Multiple companies have filed Abbreviated New Drug Applications (ANDAs) with the FDA for generic Entresto, positioning them as likely first manufacturers post-exclusivity:
- Viatris (formerly Mylan): Leads with first-to-file status on the '390 patent, securing 180-day exclusivity for generic launch around May 2026 (if no settlement delays).[2][4]
- Lupin: Filed ANDA; Paragraph IV challenges ongoing against Novartis patents.[3]
- Dr. Reddy's Laboratories: Submitted ANDA; involved in patent litigation.[3]
- Sun Pharma (via Ranbaxy): ANDA filer with disputes settled in some cases.[2]
- Alkem Laboratories, Aurobindo Pharma, Macleods, Zydus Lifesciences: Later filers, approved for manufacturing in India and eyeing U.S. entry post-2026.[3][5]
These firms already produce active pharmaceutical ingredients (APIs) or versions in markets like India, where generics launched after local patent expiry.
What Happens After Patent Cliff?
Viatris is poised for earliest U.S. generic launch due to their 180-day exclusivity, followed by others. Novartis may settle litigation for authorized generics or delayed entry. Biosimilars are unlikely as Entresto is a small-molecule combo, not biologic.[2][6] Global manufacturing shifts to India-based plants (e.g., Lupin's Gujarat facility) for cost-competitive generics.
Have There Been Any Settlements or Launches Elsewhere?
Novartis settled with Viatris for a 2026 launch; no U.S. generics yet due to ongoing suits. In Europe, generics from Krka and Accord entered post-2023 expiry. India saw launches by Ajanta and others since 2020.[3][5]
Sources
[1]: FDA Label for Entresto
[2]: DrugPatentWatch: Entresto Patents
[3]: FDA Orange Book: Entresto ANDAs
[4]: Viatris FDA Filing Status
[5]: Indian Patent Office Records
[6]: Novartis Investor Update on Entresto