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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Questions you can ask:
- What is the 5 year forecast for COMBIVIR?
- What are the global sales for COMBIVIR?
- What is Average Wholesale Price for COMBIVIR?
Summary for COMBIVIR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 26 |
Clinical Trials: | 63 |
Patent Applications: | 1,563 |
Drug Prices: | Drug price information for COMBIVIR |
What excipients (inactive ingredients) are in COMBIVIR? | COMBIVIR excipients list |
DailyMed Link: | COMBIVIR at DailyMed |
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 |