The short version
17 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Entresto
Sacubitril and Valsartan · SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 · Tablet, Film Coated · Oral · Novartis Pharmaceuticals Corporation
NDC 00078-9777-50 · 28 TABLET, FILM COATED in 1 BOTTLE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00078-0777-20) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
Data sources
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
Plans pay at point of saleⓘ
$5.23per unit
middle half $5.23–$5.23 · 393 plans · Apr 1, 2026
Est. net of rebatesⓘ
$3.14–$3.92
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
7%of plans cover it
tier 3 · prior auth 0% · step therapy 25% · qty limit 97%
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for sacubitril and valsartan (oral solid) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $1,031.17 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA207620
- TE code
- AB
- Approval date
- Jul 7, 2015
- Patents / exclusivity
- 24 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 11058667 | May 9, 2036 |
| patent | 11058667 | May 9, 2036 |
| patent | 11058667 | May 9, 2036 |
| patent | 11135192 | Aug 22, 2033 |
| patent | 11135192 | Aug 22, 2033 |
| patent | 9517226 | Aug 22, 2033 |
| patent | 9937143 | Aug 22, 2033 |
| patent | 9517226 | Aug 22, 2033 |
| patent | 9937143 | Aug 22, 2033 |
| patent | 9517226 | Aug 22, 2033 |
| patent | 9937143 | Aug 22, 2033 |
| patent | 11135192 | Aug 22, 2033 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Sacubitril and Valsartan (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Aphena Pharma Solutions - Tennessee, LLC | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Ascend Laboratories, LLC | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| AvKARE | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Novartis Pharmaceuticals Corporation | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Novugen Pharma (USA) LLC | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Synthon Chile Limitada | VALSARTAN DISODIUM 103 mg/1; SACUBITRIL SODIUM 97 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Synthon Chile Limitada | VALSARTAN DISODIUM 51 mg/1; SACUBITRIL SODIUM 49 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Alembic Pharmaceuticals Inc. | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Inc. | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Inc. | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| ANI Pharmaceuticals, Inc. | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| ANI Pharmaceuticals, Inc. | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| ANI Pharmaceuticals, Inc. | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | VALSARTAN 51 mg/1; SACUBITRIL 49 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| AvPAK | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvPAK | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvPAK | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Biocon Pharma Inc. | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Biocon Pharma Inc. | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Biocon Pharma Inc. | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Coupler LLC | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories Inc. | SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories Inc. | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories Inc. | SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Golden State Medical Supply, Inc. | SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Entresto — NDC 00078-9777-50," retrieved September 3, 2026, https://drugdashboards.com/drug/00078977750.
Free to cite with attribution — see how the data is put together.