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Details for New Drug Application (NDA): 207620
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NDA 207620 describes ENTRESTO, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ENTRESTO profile page.
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.
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 | 0078-0659-35 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0659-35) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0659-61) |
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: | Jul 7, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 1, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Apr 1, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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