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COMBIVIR Drug Profile

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Which patents cover Combivir, and what substitute generic drugs are available?

Combivir is a drug marketed by Viiv Hlthcare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in twenty-eight countries.

The generic ingredient in COMBIVIR is lamivudine; zidovudine. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. There are nineteen tentative approvals for this compound. Additional details are available on the lamivudine; zidovudine profile page.

Summary for Tradename: COMBIVIR

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Clinical Trials: see list12
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:COMBIVIR 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
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 1997RXYesYes5,905,082*PED► Subscribe ► Subscribe
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Expired Patents for Tradename: COMBIVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19974,724,232*PED► Subscribe
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19975,047,407*PED► Subscribe
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19977,119,202*PED► Subscribe
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19975,905,082*PED► Subscribe
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19974,818,538*PED► Subscribe
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Paragraph IV activity for: COMBIVIR

Drugname Dosage Strength RLD Submissiondate
lamivudine and zidovudineTablets150 mg/300 mgCombivir6/26/2007

International Patent Family for Tradename: COMBIVIR

Country Document Number Estimated Expiration
European Patent Office0517145► Subscribe
South Korea100244008► Subscribe
Australia1881092► Subscribe
Germany69232387► Subscribe
Portugal517145► 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: COMBIVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
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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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