VITEKTA Drug Patent Profile

When do Vitekta patents expire, and when can generic versions of Vitekta launch?

Vitekta is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug.

This drug has ninety-two patent family members in thirty-six countries.

The generic ingredient in VITEKTA is elvitegravir. There are six drug master file entries for this compound. Additional details are available on the elvitegravir profile page.

DrugPatentWatch^® Generic Entry Outlook for Vitekta

Vitekta was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 26, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (elvitegravir), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VITEKTA

International Patents:	92
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Patent Applications:	2,385
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VITEKTA
DailyMed Link:	VITEKTA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VITEKTA

Constraining patent/regulatory exclusivity:

8,981,103*PED

NDA:

203093

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.

US Patents and Regulatory Information for VITEKTA

VITEKTA is protected by three US patents.

This potential generic entry date is based on patent 8,981,103.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	7,635,704*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No	7,176,220*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No	7,176,220*PED				Y

EU/EMA Drug Approvals for VITEKTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences International Ltd	Vitekta	elvitegravir	EMEA/H/C/002577Vitekta 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 VITEKTA

See the table below for patents covering VITEKTA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	042095	COMPUESTO 4-OXOQUINOLINA Y APLICACION DEL MISMO COMO INHIBIDOR DE INTEGRASA DE VIH
Argentina	087046	COMPUESTOS DERIVADOS DE 4-OXOQUINOLINA
Austria	443048

Supplementary Protection Certificates for VITEKTA

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	C300624	Netherlands		PRODUCT NAME: ELVITEGRAVIR IN ALLE VORMEN ZOALS; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
1564210	CA 2013 00058	Denmark		PRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524