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COMBIVIR Drug Profile
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» See Plans and PricingWhen 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. Ten suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.
Summary for COMBIVIR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 13 |
| Clinical Trials: | 62 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COMBIVIR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COMBIVIR |
| 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 |
Recent Litigation for COMBIVIR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Glaxo Group Ltd. v. Lupin Ltd. | 2008-08-29 |
| Plaintiff(s) v. Defendant(s) | 2008-01-31 |
| Glaxo Group Ltd. v. Teva Pharmaceuticals USA Inc. | 2007-11-02 |
Pharmacology for COMBIVIR
Synonyms for COMBIVIR
| [[(2S,3S,5R)-3-azido-5-(5-methyl-2,4-dioxo-pyrimidin-1-yl)tetrahydrofuran-2-yl]methoxy-hydroxy-phosphoryl] phosphono hydrogen phosphate |
| 1-(3'-Azido-2',3'-dideoxy-beta-D-xylofuranosyl)thymine 5'-triphosphate |
| 3'-Azido-2',3'-dideoxythymidine-5'- triphosphate |
| 3'-Azido-2',3'-dideoxythymidine-5'-triphosphate |
| 3'-azido-3'-deoxythymidine 5'-(tetrahydrogen triphosphate) |
| 3'-Azido-3'-deoxythymidine 5'-triphosphate |
| 3'-azido-3'-deoxythymidine triphosphate |
| 3'-Azido-dTTP |
| 3'-Azidothymidine triphosphate |
| 3'-Deoxy-3'-azidothymidine triphosphate |
| 3'-N3-dTTP |
| 6RGF96R053 |
| 92586-35-1 |
| AZddTTP |
| AZT triphosphate |
| Azt-TP |
| AZT-triphospate |
| AZTTP |
| BDBM50370476 |
| CHEMBL193952 |
| CTK5H1433 |
| Dttp(3'N3) |
| DTXSID80239053 |
| Erythro-azt-TP |
| FT-0615084 |
| GLWHPRRGGYLLRV-XLPZGREQSA-N |
| LS-178176 |
| N3dTTP |
| NSC742231 |
| Q27265380 |
| SCHEMBL19808965 |
| Threo-azt-TP |
| Thymidine 5'-(tetrahydrogen triphosphate), 3'-azido-2', 3'-dideoxy- |
| Thymidine 5'-(tetrahydrogen triphosphate), 3'-azido-3'-deoxy- |
| UNII-6RGF96R053 |
| ZDV-TP |
| Zidovudine 5'-triphosphate |
| Zidovudine triphosphate |
| ZINC13455082 |
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 | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | Start Trial | Start Trial |
| Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | Start Trial | Start Trial |
| Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | Start Trial | Start Trial |
| Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for COMBIVIR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | 224969 | Start Trial |
| Philippines | 27190 | Start Trial |
| Germany | 19875016 | Start Trial |
| United Kingdom | 8506869 | Start Trial |
| Hungary | 201678 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for COMBIVIR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0513917 | 17/1998 | Austria | Start 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 |
| 0513917 | 98C0020 | Belgium | Start Trial | PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318 |
| 0513917 | 98C0018 | Netherlands | Start Trial | PRODUCT NAME: SAMARIUM LEXIDRONAM PENTASODIQUE; NAT. REGISTRATION NO/DATE: EU/1/97/057/001 19980205; FIRST REGISTRATION: CH - 54265 19971006 |
| 0382526 | 19675032 | Germany | Start 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 |
| 0513917 | SPC/GB98/019 | United Kingdom | Start 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 |
