You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

BARACLUDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Baraclude, and when can generic versions of Baraclude launch?

Baraclude is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Baraclude

A generic version of BARACLUDE was approved as entecavir by HETERO LABS LTD V on August 21st, 2015.

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for BARACLUDE?
  • What are the global sales for BARACLUDE?
  • What is Average Wholesale Price for BARACLUDE?
Summary for BARACLUDE
Drug patent expirations by year for BARACLUDE
Drug Prices for BARACLUDE

See drug prices for BARACLUDE

Recent Clinical Trials for BARACLUDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shanghai Zhimeng Biopharma, Inc.Phase 2
Tigermed Consulting Co., LtdPhase 2
Ascentage Pharma Group Inc.Phase 2

See all BARACLUDE clinical trials

Paragraph IV (Patent) Challenges for BARACLUDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BARACLUDE Tablets entecavir 0.5 mg and 1 mg 021797 1 2010-06-14

US Patents and Regulatory Information for BARACLUDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-001 Mar 29, 2005 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-002 Mar 29, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BARACLUDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-002 Mar 29, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-001 Mar 29, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for BARACLUDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Entecavir Mylan entecavir EMEA/H/C/004377
Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to
Authorised yes no no 2017-09-18
Bristol-Myers Squibb Pharma EEIG Baraclude entecavir EMEA/H/C/000623
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis;decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.
Authorised no no no 2006-06-26
Accord Healthcare S.L.U. Entecavir Accord entecavir EMEA/H/C/004458
Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:, , , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease., , , For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B., , Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to
Authorised yes no no 2017-09-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for BARACLUDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0481754 33/2006 Austria ⤷  Sign Up PRODUCT NAME: ENTECAVIR UND DESSEN HYDRATE; REGISTRATION NO/DATE: EU/1/06/343/001- EU/1/06/343/005 20060626
0481754 CA 2006 00033 Denmark ⤷  Sign Up
0481754 C00481754/01 Switzerland ⤷  Sign Up FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
0481754 SPC/GB06/032 United Kingdom ⤷  Sign Up PRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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 verification 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.