COMBIVIR Drug Patent Profile
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Which patents cover Combivir, and when can generic versions of Combivir launch?
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. Ten 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.
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: | 1,910 |
| 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 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 | 80035 | ⤷ Try a Trial | |
| African Regional IP Organization (ARIPO) | 136 | Substituted:- 1,3-oxathiolanes with antiviral properties. | ⤷ Try a Trial |
| Slovakia | 125793 | CRYSTALLINE OXATHIOLANE DERIVATIVES | ⤷ Try a Trial |
| Hungary | 0000344 | ⤷ Try a Trial | |
| Hong Kong | 164395 | Use of 3'-azido-3'-deoxythymidine in the treatment or prophylaxis of human retroviral infections | ⤷ Try a Trial |
| Ireland | 860677 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COMBIVIR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0382526 | SZ 22/1996 | Austria | ⤷ Try a Trial | PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE |
| 0513917 | 17/1998 | Austria | ⤷ Try a Trial | 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 |
| 0817637 | 05C0022 | France | ⤷ Try a Trial | PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217 |
| 0382526 | 19675032 | Germany | ⤷ Try a Trial | 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 |
| 0382526 | SPC/GB96/043 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH 53662 19960228; CH 53663 19960228; UK EU/1/96/015/001 19960808; UK EU/1/96/015/002 19960808 |
| 0513917 | SPC/GB98/019 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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