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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 213728


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NDA 213728 describes SACUBITRIL AND VALSARTAN, which is a drug marketed by Alembic, Alkem Labs Ltd, Biocon Pharma, Crystal, Dr Reddys, Hetero Labs Ltd Iii, Laurus, Lupin, Macleods Pharms Ltd, MSN, Novugen Pharma Sdn, Torrent, and Zydus Pharms, and is included in thirteen NDAs. It is available from twenty suppliers. Additional details are available on the SACUBITRIL AND VALSARTAN profile page.

The generic ingredient in SACUBITRIL AND VALSARTAN is sacubitril; valsartan. There are eleven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 213728
Tradename:SACUBITRIL AND VALSARTAN
Applicant:Macleods Pharms Ltd
Ingredient:sacubitril; valsartan
Patents:0
Pharmacology for NDA: 213728
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Neprilysin Inhibitors
Suppliers and Packaging for NDA: 213728
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213728 ANDA Macleods Pharmaceuticals Limited 33342-570 33342-570-09 60 TABLET in 1 BOTTLE (33342-570-09)
SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213728 ANDA Macleods Pharmaceuticals Limited 33342-570 33342-570-57 180 TABLET in 1 BOTTLE (33342-570-57)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength24MG;26MG
Approval Date:Oct 16, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength49MG;51MG
Approval Date:Oct 16, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength97MG;103MG
Approval Date:Oct 16, 2024TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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