Elvitegravir - Generic Drug Details

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:	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

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

See all elvitegravir clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for elvitegravir

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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					Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No					Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No					Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No					Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No					Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No					Y

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

International Patents for elvitegravir

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0510114	cristal estável de composto 4-oxoquinolina
Peru	20040840	DERIVADOS DE 4-OXOQUINOLINA COMO INHIBIDORES DE LA INTEGRASA DEL VIH
European Patent Office	4059923	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)
Norway	20161297	Stabil krystall av 4-oxoquinolinforbindelse
European Patent Office	3281939	MÉTHODE POUR PRÉPARATION D'UN CRISTAL STABLE DE COMPOSÉ 4-OXOQUINOLINE (METHOD OF PRODUCING STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND)
Portugal	1564210
Spain	2388441

Supplementary Protection Certificates for elvitegravir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	PA2013018	Lithuania		PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013 05 24 EU/1/13/830/002 20130524
1564210	CR 2013 00058	Denmark		PRODUCT NAME: ELVITEGRAVIR ELLER ET HYDRAT, ET SOLVAT, EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
1564210	132013902209844	Italy		PRODUCT NAME: COMPRENDENTE IL PRODOTTO ELVITEGRAVIR COME UNO DEI PRINCIPI ATTIV(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/830/001-002, 20130524
1564210	489	Finland
1564210	122013000088	Germany		PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT, TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 20130524
1564210	C 2013 033	Romania		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	C20130029 00095	Estonia		CHANGE OF OWNER'S ADDRESS