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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Combivir
A generic version of COMBIVIR was approved as lamivudine; zidovudine by AUROBINDO PHARMA LTD on May 15th, 2012.
Summary for COMBIVIR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 19 |
Clinical Trials: | 63 |
Patent Applications: | 2,337 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for COMBIVIR |
What excipients (inactive ingredients) are in COMBIVIR? | COMBIVIR excipients list |
DailyMed Link: | COMBIVIR at DailyMed |


Recent Clinical Trials for COMBIVIR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Augusta University | Phase 4 |
Massachusetts General Hospital | Phase 2 |
AIDS Clinical Trials Group | Phase 3 |
Pharmacology for COMBIVIR
Anatomical Therapeutic Chemical (ATC) Classes for COMBIVIR
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 |