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: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208401

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NDA 208401 describes QBRELIS, which is a drug marketed by Silvergate Pharms 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 QBRELIS profile page.

The generic ingredient in QBRELIS is lisinopril. There are twenty-one drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the lisinopril profile page.
Summary for 208401
Tradename:QBRELIS
Applicant:Silvergate Pharms
Ingredient:lisinopril
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 208401
Medical Subject Heading (MeSH) Categories for 208401
Suppliers and Packaging for NDA: 208401
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QBRELIS lisinopril SOLUTION;ORAL 208401 NDA Silvergate Pharmaceuticals, Inc. 52652-3001 52652-3001-1 150 mL in 1 BOTTLE (52652-3001-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Jul 29, 2016TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 6, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE MYOCARDIAL INFARCTION
Patent:  Start TrialPatent Expiration:Nov 6, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERTENSION
Patent:  Start TrialPatent Expiration:Nov 6, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF HEART FAILURE

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