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Last Updated: August 7, 2020

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BARACLUDE Drug Profile

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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. Seventeen suppliers are listed for this compound. Additional details are available on the entecavir profile page.

US ANDA Litigation and Generic Entry Outlook for Baraclude

A generic version of BARACLUDE was approved as entecavir by TEVA PHARMS USA on August 26th, 2014.

  Start Trial

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
Third Affiliated Hospital, Sun Yat-Sen UniversityN/A
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.N/A
Bristol-Myers SquibbPhase 1

See all BARACLUDE clinical trials

Paragraph IV (Patent) Challenges for BARACLUDE
Tradename Dosage Ingredient NDA Submissiondate
BARACLUDE TABLET;ORAL entecavir 021797 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   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-001 Mar 29, 2005 AB RX Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-002 Mar 29, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 SOLUTION;ORAL 021798-001 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-001 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-002 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for BARACLUDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0481754 C00481754/01 Switzerland   Start Trial FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
0481754 33/2006 Austria   Start Trial PRODUCT NAME: ENTECAVIR UND DESSEN HYDRATE; REGISTRATION NO/DATE: EU/1/06/343/001- EU/1/06/343/005 20060626
0481754 SPC/GB06/032 United Kingdom   Start Trial 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
0481754 06C0040 France   Start Trial PRODUCT NAME: ENTECAVIR; REGISTRATION NO/DATE: EU/1/06/343/001 20060626
0481754 91275 Luxembourg   Start Trial CERTIFICATE TITLE: ENTECAVIR ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BARACLUDE); FIRST REGISTRATION: 20060626
0481754 C300241 Netherlands   Start Trial PRODUCT NAME: ENTECAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT, IN HET BIJZONDER ENTECAVIRMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/06/343/001-EU/1/06/343/005 20060626
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Mallinckrodt

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