.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021654

« 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 seven 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. Eighteen suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

Summary for NDA: 021654

Tradename:
LOVAZA
Applicant:
Smithkline Beecham
Ingredient:
omega-3-acid ethyl esters
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021654

Ingredient-typeFatty Acids, Omega-3

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 0173-0783 0173-0783-02 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0173-0783-02)
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)

Summary 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 Orange Book Patents for NDA: 021654

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 20045,502,077► subscribe
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 20045,698,594► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc