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Serving leading biopharmaceutical companies globally:

Argus Health
Novartis
Accenture
Healthtrust
Fish and Richardson
Julphar
McKinsey
Mallinckrodt
Daiichi Sankyo
Federal Trade Commission

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021798

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NDA 021798 describes BARACLUDE, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from one supplier. Additional details are available on the BARACLUDE profile page.

The generic ingredient in BARACLUDE is entecavir. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.

Summary for NDA: 021798

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021798

Suppliers and Packaging for NDA: 021798

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BARACLUDE
entecavir
SOLUTION;ORAL 021798 NDA E.R. Squibb & Sons, L.L.C. 0003-1614 0003-1614-12 1 BOTTLE in 1 CARTON (0003-1614-12) > 210 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength0.05MG/ML
Approval Date:Mar 29, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 20, 2017
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Sep 20, 2017
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired Orange Book Patents for NDA: 021798

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
BARACLUDE
entecavir
SOLUTION;ORAL021798-001Mar 29, 2005► Subscribe► Subscribe
Bristol Myers Squibb
BARACLUDE
entecavir
SOLUTION;ORAL021798-001Mar 29, 2005► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
QuintilesIMS
Daiichi Sankyo
UBS
Argus Health
McKesson
Fuji
Novartis
Teva

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