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Last Updated: November 2, 2024

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. Nine suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Combivir

A generic version of COMBIVIR was approved as lamivudine; zidovudine by LUPIN LTD on May 15th, 2012.

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Summary for COMBIVIR
Drug patent expirations by year for COMBIVIR
Drug Prices for COMBIVIR

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Recent Clinical Trials for COMBIVIR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Augusta UniversityPhase 4
Massachusetts General HospitalPhase 2
AIDS Clinical Trials GroupPhase 3

See all COMBIVIR clinical trials

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 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
>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.
Withdrawn 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
Israel 93318 1,3-oxathiolane derivatives, processes for the preparation thereof and pharmaceutical compositions containing the same ⤷  Sign Up
Australia 656379 ⤷  Sign Up
Norway 921947 ⤷  Sign Up
Ireland 56503 ANTIVIRAL NUCLEOSIDES ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COMBIVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3494972 2024C/522 Belgium ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, MET INBEGRIP VAN DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
0817637 05C0022 France ⤷  Sign Up PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
0382526 19675032 Germany ⤷  Sign Up PRODUCT NAME: LAMIVUDINE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH GEEIGNETEN SALZES; NAT. REGISTRATION NO/DATE: EU/1/96/015/001-002 19960808 FIRST REGISTRATION: CH 53662 53663 19960228
3494972 LUC00346 Luxembourg ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.