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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-002 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-002 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
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 |
---|---|---|---|
Argentina | 096100 | CRISTAL ESTABLE DE DERIVADO DE 4-OXOQUINOLINA, SU USO COMO AGENTE ANTI-HIV Y SU USO EN COMPOSICIONES ANTI-HIV | ⤷ Try a Trial |
Norway | 20161297 | Stabil krystall av 4-oxoquinolinforbindelse | ⤷ Try a Trial |
South Africa | 200610647 | Stable crystal of 4-oxoquinoline compound | ⤷ Try a Trial |
Norway | 20230913 | Stabil krystall av 4-oxoquinolinforbindelse | ⤷ Try a Trial |
Serbia | 52375 | STABILNI KRISTALI JEDINJENJA 4-OKSOHINOLINA (STABLE CRYSTAL OF 4-OXOQUINOLINE COMPUND) | ⤷ 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 | 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 | 300624 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527 |
1564210 | 1390052-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR ELLER ETT HYDRAT, ETT SOLVAT, EN TAUTOMER, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/830/001 20130524; PERIOD OF VALIDITY (FROM - UNTIL): 2023-11-21 - 2028-05-26 |
2487166 | PA2016038 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |