Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204308

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NDA 204308 describes EPANED KIT, which is a drug marketed by Silvergate Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EPANED KIT profile page.

The generic ingredient in EPANED KIT is enalapril maleate. There are twenty-seven drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.
Summary for 204308
Tradename:EPANED KIT
Applicant:Silvergate Pharms
Ingredient:enalapril maleate
Patents:4
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 204308
Suppliers and Packaging for NDA: 204308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPANED KIT enalapril maleate FOR SOLUTION;ORAL 204308 NDA Silvergate Pharmaceuticals, Inc. 52652-1001 52652-1001-1 1 KIT in 1 CARTON (52652-1001-1) * 150 mL in 1 BOTTLE * 150 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 204308
Tradename Dosage Ingredient NDA Submissiondate
EPANED KIT FOR SOLUTION;ORAL enalapril maleate 204308 2016-06-21

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength1MG/ML
Approval Date:Aug 13, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 6, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 6, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERTENSION
Patent:  Start TrialPatent Expiration:Nov 6, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION

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