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EPZICOM Drug Profile

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Epzicom is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from six suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-four patent family members in fifty-six countries.

The generic ingredient in EPZICOM is abacavir sulfate; lamivudine. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. There are seven tentative approvals for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

Summary for Tradename: EPZICOM

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Bulk Api Vendors: see list46
Clinical Trials: see list10
Patent Applications: see list4,519
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EPZICOM at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004RXYesYes5,905,082*PED► subscribe ► subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004RXYesYes6,294,540*PED► subscribeY► subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004RXYesYes6,417,191*PED► subscribe ► subscribe
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Expired Patents for Tradename: EPZICOM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 20045,034,394*PED► subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 20045,047,407*PED► subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 20047,119,202*PED► subscribe
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Paragraph IV activity for: EPZICOM

Drugname Dosage Strength RLD Submissiondate
abacavir sulfate and lamivudineTablets600 mg/300 mgEpzicom9/27/2007

International Patent Family for Tradename: EPZICOM

Country Document Number Estimated Expiration
Japan2851480► subscribe
European Patent Office0817637► subscribe
Brazil9809124► 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: EPZICOM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
99C0033Belgium► subscribePRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
90028Netherlands► subscribePRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
0195Netherlands► subscribe300195, 20160328, EXPIRES: 20191216
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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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