ELVITEGRAVIR - Generic Drug Details
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What are the generic sources for elvitegravir and what is the scope of patent protection?
Elvitegravir
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elvitegravir has ninety-two patent family members in thirty-six countries.
There are six drug master file entries for elvitegravir.
Summary for ELVITEGRAVIR
International Patents: | 92 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 64 |
Patent Applications: | 2,707 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELVITEGRAVIR |
DailyMed Link: | ELVITEGRAVIR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ELVITEGRAVIR
Generic Entry Date for ELVITEGRAVIR*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ELVITEGRAVIR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | N/A |
University of California, Los Angeles | Early Phase 1 |
Merck Sharp & Dohme Corp. | Early Phase 1 |
US Patents and Regulatory Information for ELVITEGRAVIR
EU/EMA Drug Approvals for ELVITEGRAVIR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Gilead Sciences International Ltd | Vitekta | elvitegravir | EMEA/H/C/002577 Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir. |
Withdrawn | no | no | no | 2013-11-13 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ELVITEGRAVIR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2005002092 | 4-OXOQUINOLINE COMPOUND AND ITS USE AS HIV INTEGRASE INHIBITOR | ⤷ Try a Trial |
Canada | 2470365 | COMPOSES 4-OXOQUINOLINIQUES ET LEUR UTILISATION COMME INHIBITEUR DE LA VIH-INTEGRASE (4-OXOQUINOLINE COMPOUND AND USE THEREOF AS HIV INTEGRASE INHIBITOR) | ⤷ Try a Trial |
Austria | 443048 | ⤷ Try a Trial | |
Norway | 20065790 | ⤷ Try a Trial | |
Mexico | PA06013405 | CRISTAL ESTABLE DEL COMPUESTO 4-OXOQUINOLINA. (STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND.) | ⤷ Try a Trial |
European Patent Office | 2272516 | Composé d'oxoquinoline 4 et utilisation associée en tant qu'inhibiteur contre l'intégrase du HIV (4-Oxoquinoline compound and use thereof as HIV integrase inhibitor) | ⤷ Try a Trial |
Luxembourg | 92307 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ELVITEGRAVIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1564210 | 2013/052 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR OR A HYDRATE, SOLVATE, TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527 |
1564210 | CA 2013 00058 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524 |
1564210 | SPC/GB13/065 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527 |
1564210 | C 2013 033 | Romania | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR OPTIONAL SUB FORMA DE SARE, SOLVAT SAU HIDRATACCEPTABILFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001, EU/1/13/830/002; DATE OF NATIONAL AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830/001, EU/1/13/830/002; DATE OF FIRST AUTHORISATION IN EEA: 20130524 |
1564210 | PA2013018 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013 05 24 EU/1/13/830/002 20130524 |
1564210 | 2013C/063 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR SOUS TOUTES LES FORMES COMME PROTEGE PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001 20130527 |
1564210 | C01564210/01 | Switzerland | ⤷ Try a Trial | CHANGE OF ADDRESS OF THE OWNER: JAPAN TOBACCO INC., 1-1, TORANOMON 4-CHOME, MINATO-KU, TOKYO 105-6927, JP |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |