Details for New Drug Application (NDA): 218591
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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
Generic Entry Date for 218591*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, PELLETS;ORAL |
*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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