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Abacavir sulfate; lamivudine; zidovudine - Generic Drug Details

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Abacavir sulfate; lamivudine; zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare and Lupin Ltd, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are eleven drug master file entries for abacavir sulfate; lamivudine; zidovudine. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: abacavir sulfate; lamivudine; zidovudine

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list11
Suppliers / Packaging: see list4
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Tentative approvals for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORALEQ 300MG BASE; 150MG; 300MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 2000RXYes6,294,540*PED► subscribeY► subscribe
Lupin Ltd
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL202912-001Dec 5, 2013RXNo► subscribe► subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 2000RXYes6,417,191*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: abacavir sulfate; lamivudine; zidovudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 20007,119,202*PED► subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 20004,724,232► subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 20004,837,208► subscribe
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International Patent Family for Ingredient: abacavir sulfate; lamivudine; zidovudine

Country Document Number Estimated Expiration
Japan2954357► subscribe
World Intellectual Property Organization (WIPO)9852571► subscribe
Taiwan480259► 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: ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0195Netherlands► subscribe300195, 20160328, EXPIRES: 20191216
2005 00028Denmark► subscribe
0028Netherlands► 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
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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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