BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

US Army
Healthtrust
US Department of Justice
QuintilesIMS
Cipla
Baxter
Teva
Covington
Farmers Insurance
Merck

Generated: January 22, 2018

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 021798
Tradename:BARACLUDE
Applicant:Bristol Myers Squibb
Ingredient:entecavir
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

Profile 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 US Patents for NDA 021798

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005 ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Covington
Julphar
Express Scripts
Johnson and Johnson
Deloitte
Boehringer Ingelheim
Dow

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.

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