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OmniRx › Tools › Generic competition check › Sacubitril; Valsartan

Generic competition · all medicines · read 12 November 2026

Is there a generic of Sacubitril; Valsartan, and who makes it?

Sacubitril; Valsartan appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 16 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 8.9 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Sacubitril; Valsartan2 dosage-form groups in the Orange Book
16generic makers listed
  1. Sacubitril; Valsartan appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 16 generic makers listed as marketed across them.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came 8.9 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Entresto. 16 generic makers with 48 generic products listed as marketed; the first generic approval is dated 28 May 2024.

201520202025203020352040016brand 2015Alembic Pharmaceuticals Ltd, first approval 28 May 2024Crystal Pharmaceutical Suzhou Co Ltd, first approval 28 May 2024Laurus Labs Ltd, first approval 28 May 2024Zydus Pharmaceuticals Usa Inc, first approval 9 July 2024Torrent Pharmaceuticals Ltd, first approval 22 August 2024Biocon Pharma Ltd, first approval 30 August 2024Alkem Laboratories Ltd, first approval 16 September 2024Macleods Pharmaceuticals Ltd, first approval 16 October 2024Lupin Inc, first approval 8 January 2025Dr Reddys Laboratories Ltd, first approval 13 January 2025Msn Laboratories Private Ltd, first approval 16 July 2025Novugen Pharma Sdn Bhd, first approval 16 July 2025Hetero Labs Ltd Unit Iii, first approval 17 July 2025Somerset Therapeutics Llc, first approval 20 January 2026Umedica Laboratories Private Ltd, first approval 4 August 2026Aurobindo Pharma Ltd, first approval 2 September 2026data datePatent 9388134*PED listed to expire 8 May 2027Patent 8877938 listed to expire 27 May 2027Patent 8877938*PED listed to expire 27 November 2027Patent 11135192 listed to expire 22 August 2033Patent 9517226 listed to expire 22 August 2033Patent 9937143 listed to expire 22 August 2033Patent 11058667 listed to expire 9 May 2036
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Alembic Pharmaceuticals Ltd28 May 20243
Crystal Pharmaceutical Suzhou Co Ltd28 May 20243
Laurus Labs Ltd28 May 20243
Zydus Pharmaceuticals Usa Inc9 July 20243
Torrent Pharmaceuticals Ltd22 August 20243
Biocon Pharma Ltd30 August 20243
Alkem Laboratories Ltd16 September 20243
Macleods Pharmaceuticals Ltd16 October 20243
Lupin Inc8 January 20253
Dr Reddys Laboratories Ltd13 January 20253
Msn Laboratories Private Ltd16 July 20253
Novugen Pharma Sdn Bhd16 July 20253

4 more makers are listed in the data.

Patents and exclusivities still listed

  • 8 May 2027Patent 9388134*PED
  • 27 May 2027Patent 8877938 drug substance
  • 27 November 2027Patent 8877938*PED
  • 22 August 2033Patent 11135192
  • 22 August 2033Patent 9517226
  • 22 August 2033Patent 9937143
  • 9 May 2036Patent 11058667

Capsule, Pellets, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Entresto Sprinkle. No generic is listed as marketed.

2020202520302035204001brand 2024data datePatent 8877938 listed to expire 27 May 2027Patent 10722471 listed to expire 2 February 2037
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 27 May 2027Patent 8877938 drug substance
  • 2 February 2037Patent 10722471 drug product

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.