DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 207620
» See Plans and Pricing
The generic ingredient in ENTRESTO is sacubitril; valsartan. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 207620
Tradename: | ENTRESTO |
Applicant: | Novartis Pharms Corp |
Ingredient: | sacubitril; valsartan |
Patents: | 6 |
Generic Entry Opportunity Date for 207620
Generic Entry Date for 207620*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 207620
Mechanism of Action | Neprilysin Inhibitors Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 207620
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620 | NDA | Novartis Pharmaceuticals Corporation | 0078-0659 | 0078-0659-20 | 60 TABLET, FILM COATED in 1 BOTTLE (0078-0659-20) |
ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620 | NDA | Novartis Pharmaceuticals Corporation | 0078-0659 | 0078-0659-67 | 180 TABLET, FILM COATED in 1 BOTTLE (0078-0659-67) |
Paragraph IV (Patent) Challenges for 207620
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ENTRESTO | TABLET;ORAL | sacubitril; valsartan | 207620 | 2019-07-08 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 24MG;26MG | ||||
Approval Date: | Jul 7, 2015 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Apr 1, 2023 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Regulatory Exclusivity Expiration: | Jan 7, 2021 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Regulatory Exclusivity Expiration: | Jul 7, 2020 | ||||||||
Regulatory Exclusivity Use: |
Complete Access Available with Subscription