Elvitegravir - Generic Drug Details
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What are the generic 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: | 65 |
| Patent Applications: | 2,707 |
| 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
*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 |
|---|---|
| Kenya Medical Research Institute | Phase 1 |
| Centre for the AIDS Programme of Research in South Africa | Phase 1 |
| University of Pittsburgh | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for elvitegravir
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 | 203093-002 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-002 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-001 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | VITEKTA | elvitegravir | TABLET;ORAL | 203093-002 | Sep 24, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|
| Canada | 2470365 | COMPOSES 4-OXOQUINOLINIQUES ET LEUR UTILISATION COMME INHIBITEUR DE LA VIH-INTEGRASE (4-OXOQUINOLINE COMPOUND AND USE THEREOF AS HIV INTEGRASE INHIBITOR) | ⤷ Sign Up |
| Norway | 20043004 | ⤷ Sign Up | |
| Lithuania | 3281939 | ⤷ Sign Up | |
| Malaysia | 136173 | 4-OXOQUINOLINE COMPOUND AND USE THEREOF AS HIV INTEGRASE INHIBITOR | ⤷ Sign Up |
| Slovenia | 1564210 | ⤷ Sign Up | |
| New Zealand | 533641 | 4-oxoquinoline compounds and utilization thereof as HIV integrase inhibitors | ⤷ Sign Up |
| Norway | 2013015 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | C20130029 00095 | Estonia | ⤷ Sign Up | CHANGE OF OWNER'S ADDRESS |
| 1564210 | 1390052-7 | Sweden | ⤷ Sign Up | 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 |
| 1564210 | C300624 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIR IN ALLE VORMEN ZOALS; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524 |
| 1564210 | SPC/GB13/065 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIR; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527 |
| 3281939 | 122023000055 | Germany | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIR UND TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
