cliffwatch

sacubitril; valsartan · Novartis Pharms Corp · NDA 207620

Entresto

Earliest generic entry, as listed · earliest of 3 marketed strengths
9 May 2036

Blocked by patent: US 11058667. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

FDA has approved 3 generic applications (ANDAs) for Entresto, though its earliest generic-entry date is 9 May 2036 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 6 unexpired

8 Orange Book listing rows for 6 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11058667use U-3170 · sets the listed date9 May 2036
US 11135192use U-308422 Aug 2033
US 9517226use U-308422 Aug 2033
US 9937143use U-308422 Aug 2033
US 8877938drug substance, drug product27 Nov 2027
US 8877938 listing rowdrug substance, drug product27 May 2027
US 8877938 listing rowpediatric extension27 Nov 2027
US 9388134use U-17238 May 2027
US 9388134 listing rowuse U-17238 Nov 2026
US 9388134 listing rowpediatric extension8 May 2027

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • 25 Oct 2026Generic approved · 207620-001
  • 25 Oct 2026Generic approved · 207620-001
  • 25 Oct 2026Generic approved · 207620-001

Products covered · 3

NDA · productFormStrengthListed expiry
207620 · 001 · RLDtablet, oral24MG;26MG9 May 2036
207620 · 002 · RLDtablet, oral49MG;51MG9 May 2036
207620 · 003 · RLDtablet, oral97MG;103MG9 May 2036