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 | 203093-002 | 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 | |||
| 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 | |||
| 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 | |||
| >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 |
|---|---|---|---|
| Austria | 443048 | ⤷ Try a Trial | |
| Portugal | 1564210 | ⤷ Try a Trial | |
| Czech Republic | 2004764 | 4-Oxochinolinová sloučenina a její použití jako inhibitoru HIV-integrázy (4-Oxoquinoline compound and use thereof as HIV-integrase inhibitor) | ⤷ Try a Trial |
| Malaysia | 134672 | STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND | ⤷ Try a Trial |
| New Zealand | 533641 | 4-oxoquinoline compounds and utilization thereof as HIV integrase inhibitors | ⤷ Try a Trial |
| Spain | 2329240 | ⤷ 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 | 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 | PA2013018,C1564210 | 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 |
| 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 | C300624 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR IN ALLE VORMEN ZOALS; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524 |
| 1564210 | 489 | Finland | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
