Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Express Scripts
Colorcon
Baxter
McKesson

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021654

See Plans and Pricing

« Back to Dashboard

NDA 021654 describes LOVAZA, which is a drug marketed by Smithkline Beecham and is included in one NDA. It is available from two suppliers. Additional details are available on the LOVAZA profile page.

The generic ingredient in LOVAZA is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.
Summary for 021654
Tradename:LOVAZA
Applicant:Smithkline Beecham
Ingredient:omega-3-acid ethyl esters
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021654
Suppliers and Packaging for NDA: 021654
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654 NDA GlaxoSmithKline LLC 0173-0884 0173-0884-08 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0173-0884-08)
LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-726 66993-726-32 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (66993-726-32)
Paragraph IV (Patent) Challenges for 021654
Tradename Dosage Ingredient NDA Submissiondate
LOVAZA CAPSULE;ORAL omega-3-acid ethyl esters 021654 2008-11-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:Nov 10, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021654

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004   Start Trial   Start Trial
Smithkline Beecham LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004   Start Trial   Start Trial
Smithkline Beecham LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Dow
Mallinckrodt
McKesson
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.