Details for New Drug Application (NDA): 218591
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NDA 218591 describes ENTRESTO SPRINKLE, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ENTRESTO SPRINKLE profile page.
The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 218591
| Tradename: | ENTRESTO SPRINKLE |
| Applicant: | Novartis |
| Ingredient: | sacubitril; valsartan |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218591
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 218591
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
Suppliers and Packaging for NDA: 218591
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENTRESTO SPRINKLE | sacubitril; valsartan | CAPSULE, PELLETS;ORAL | 218591 | NDA | Novartis Pharmaceuticals Corporation | 0078-1231 | 0078-1231-20 | 60 PELLET in 1 BOTTLE (0078-1231-20) |
| ENTRESTO SPRINKLE | sacubitril; valsartan | CAPSULE, PELLETS;ORAL | 218591 | NDA | Novartis Pharmaceuticals Corporation | 0078-1238 | 0078-1238-20 | 60 PELLET in 1 BOTTLE (0078-1238-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, PELLETS;ORAL | Strength | 6MG;6MG | ||||
| Approval Date: | Apr 12, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 2, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HEART FAILURE WITH ORAL PELLETS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 15, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 27, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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