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BARACLUDE Drug Profile

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Baraclude is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in twenty-seven countries.

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

Summary for Tradename: BARACLUDE

Patents:1
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
BARACLUDE
entecavir
TABLET;ORAL021797-001Mar 29, 2005RXNo5,206,244*PED► subscribe ► subscribe
Bristol Myers Squibb
BARACLUDE
entecavir
TABLET;ORAL021797-002Mar 29, 2005RXYes► subscribe► subscribe
Bristol Myers Squibb
BARACLUDE
entecavir
TABLET;ORAL021797-001Mar 29, 2005RXNo► subscribe► subscribe
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Expired Patents for Tradename: BARACLUDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
BARACLUDE
entecavir
SOLUTION;ORAL021798-001Mar 29, 20055,206,244*PED► subscribe
Bristol Myers Squibb
BARACLUDE
entecavir
TABLET;ORAL021797-002Mar 29, 20055,206,244*PED► subscribe
Bristol Myers Squibb
BARACLUDE
entecavir
SOLUTION;ORAL021798-001Mar 29, 20055,908,638► subscribe
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Paragraph IV activity for: BARACLUDE

Drugname Dosage Strength RLD Submissiondate
entecavirTablets0.5 mg and 1 mgBaraclude6/14/2010

Non-Orange Book Patents for Tradename: BARACLUDE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,340,816 Hydroxymethyl(methylenecyclopentyl) purines and pyrimidines► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: BARACLUDE

Country Document Number Estimated Expiration
Ireland913451► subscribe
Norway914089► subscribe
Finland109905► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BARACLUDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00241Netherlands► subscribePRODUCT 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
C0040France► subscribePRODUCT NAME: ENTECAVIR; REGISTRATION NO/DATE: EU/1/06/343/001 20060626
275Luxembourg► subscribeCERTIFICATE TITLE: ENTECAVIR ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BARACLUDE); FIRST REGISTRATION: 20060626
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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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