Gilead Sciences Company Profile

What is the competitive landscape for GILEAD SCIENCES, and what generic alternatives to GILEAD SCIENCES drugs are available?

GILEAD SCIENCES has twenty-two approved drugs.

There are seventy-eight US patents protecting GILEAD SCIENCES drugs.

There are two thousand and thirty-eight patent family members on GILEAD SCIENCES drugs in sixty-three countries and three hundred and twenty-two supplementary protection certificates in nineteen countries.

Summary for Gilead Sciences

International Patents:	2038
US Patents:	78
Tradenames:	18
Ingredients:	18
NDAs:	22
Patent Litigation for Gilead Sciences:	See patent lawsuits for Gilead Sciences
PTAB Cases with Gilead Sciences as patent owner:	See PTAB cases with Gilead Sciences as patent owner

Drugs and US Patents for Gilead Sciences

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	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No	8,580,765*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes	9,744,181		Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,334,270*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	10,039,718*PED				Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	9,457,036		Y

Expired US Patents for Gilead Sciences

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	6,043,230*PED
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	6,642,245*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012	5,977,089*PED
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	6,642,245*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	4,808,716
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	5,914,331*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012	5,935,946*PED

Paragraph IV (Patent) Challenges for GILEAD SCIENCES drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	200 mg/25 mg/300 mg		2015-05-20
	Tablets	150 mg		2015-12-09
	Tablets	600 mg/200 mg/300 mg		2008-12-29
	Tablets	150 mg, 200 mg, and 250 mg		2012-05-17
	Tablets	150 mg, 150 mg, 200 mg, 300 mg		2018-10-04
	Tablets	300 mg		2010-01-26

International Patents for Gilead Sciences Drugs

Country	Patent Number	Estimated Expiration
South Korea	101664154
Poland	2487166
Australia	2017202461
Hungary	0301307
Canada	2611520
Hungary	S1500052
Israel	244122

Supplementary Protection Certificates for Gilead Sciences Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	PA2012008,C1419152	Lithuania		PRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
2430014	92956	Luxembourg		PRODUCT NAME: LEDIPASVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118
1419152	CA 2012 00021	Denmark
1663240	223 5021-2015	Slovakia		PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
2487166	17C1001	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2487162	C20170003 00221	Estonia		PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014
2430014	4/2016	Austria		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 (MITTEILUNG) 20141118

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Gilead
• Gilead Sciences
• Gilead Sciences Inc