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Last Updated: June 28, 2022

COMBIVIR Drug Patent Profile


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When do Combivir patents expire, and what generic alternatives are available?

Combivir is a drug marketed by Viiv Hlthcare and is included in one NDA.

The generic ingredient in COMBIVIR is lamivudine; zidovudine. There are twenty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

US Patents and Regulatory Information for COMBIVIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 COMBIVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for COMBIVIR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Teva Pharma B.V.  Lamivudine/Zidovudine Teva lamivudine, zidovudine EMEA/H/C/001236
Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.
Authorised yes no no 2011-02-28
ViiV Healthcare BV Combivir lamivudine, zidovudine EMEA/H/C/000190
Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.
Authorised no no no 1998-03-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for COMBIVIR

See the table below for patents covering COMBIVIR around the world.

Country Patent Number Title Estimated Expiration
Australia 1881092 See Plans and Pricing
Egypt 19958 Process for preparing of 1.3 oxathiolane nucleoside analogues See Plans and Pricing
Spain 2006672 PROCEDIMIENTO PARA PREPARAR FORMULACIONES FARMACEUTICAS A BASE DE 3'-AZIDO-NUCLEOSIDOS. (New and known 3-azido-nucleoside(s) - useful for therapy of viral and bacterial infections esp. HIV retro-viral infections and resistant gram negative bacterial infections) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COMBIVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513917 17/1998 Austria See Plans and Pricing PRODUCT NAME: LAMIVUDIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, UND ZIDOVUDIN; REGISTRATION NO/DATE: EU/1/98/058/001 EU/1/98/058/002 19980318
0382526 C960025 Netherlands See Plans and Pricing PRODUCT NAME: LAMIVUDINUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/015/001 - EU/1/96/015/002 19960808
0513917 C980018 Netherlands See Plans and Pricing PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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AstraZeneca

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