ELVITEGRAVIR - Generic Drug Details
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What are the generic drug sources for elvitegravir and what is the scope of freedom to operate?
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Withdrawn | no | no | no | 2013-11-13 | |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 |
---|---|---|---|
Cyprus | 1110690 | ⤷ Try a Trial | |
European Patent Office | 1564210 | COMPOSES 4-OXOQUINOLINIQUES ET LEUR UTILISATION COMME INHIBITEUR DE LA VIH-INTEGRASE (4-OXOQUINOLINE COMPOUNDS AND UTILIZATION THEREOF AS HIV INTEGRASE INHIBITORS) | ⤷ Try a Trial |
Croatia | P20120681 | ⤷ Try a Trial | |
Peru | 20120361 | COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN FORMAS CRISTALINAS DE ACIDO 6-(3-CLORO-2-FLUOROBENCIL)-1-[(S)-1-HIDROXIMETIL-2-METILPROPIL]-7-METOXI-4-OXO-1, 4-DIHIDROQUINOLINA-3-CARBOXILICO | ⤷ Try a Trial |
European Patent Office | 3406596 | 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 |
Portugal | 3281939 | ⤷ 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 | 489 | Finland | ⤷ Try a Trial | |
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 |
2487166 | PA2016038 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
1564210 | 203 5022-2013 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR ALEBO JEHO HYDRAT, SOLVAT, TAUTOMER ALEBO FARMACEUTICKY PRIJATELNA SOL; NAT. REGISTRATION NO/DATE: EU/1/13/830/001 - EU/1/13/830/002 20130527; FIRST REGISTRATION: EU EU/1/13/830/001 - EU/1/13/830/002 20130527 |
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 | 122013000088 | Germany | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT, TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 20130524 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |