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-four approved drugs.

There are eighty-two US patents protecting GILEAD SCIENCES drugs.

There are two thousand two hundred and eighty-one patent family members on GILEAD SCIENCES drugs in sixty-six countries and three hundred and seventy-two supplementary protection certificates in nineteen countries.

Summary for Gilead Sciences

International Patents:	2281
US Patents:	82
Tradenames:	19
Ingredients:	19
NDAs:	24
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	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-001	Aug 28, 2019		RX	Yes	No	8,822,430*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	10,086,011*PED				Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-002	Aug 28, 2019		RX	Yes	Yes	8,334,270*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	11,116,783*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes	9,949,994*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	9,296,782		Y	Y

Expired US Patents for Gilead Sciences

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	5,977,089*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	5,922,695*PED
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	8,592,397
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	6,949,535
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	6,642,245*PED
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	8,492,389
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	8,716,264

Paragraph IV (Patent) Challenges for GILEAD SCIENCES drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	300 mg		2010-01-26
	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

International Patents for Gilead Sciences Drugs

Country	Patent Number	Estimated Expiration
Hungary	E049192
Hong Kong	1215679
Singapore	2014011704
South Africa	200701826
South Korea	20140014393
Russian Federation	2004121464
South Korea	20160084478

Supplementary Protection Certificates for Gilead Sciences Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	1390052-7	Sweden		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	SPC/GB13/065	United Kingdom		PRODUCT NAME: ELVITEGRAVIR; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
1632232	300853	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1301519	C01301519/01	Switzerland		PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016
2487162	300861	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121
1663240	223 5021-2015	Slovakia		PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
3808743	CR 2022 00035	Denmark		PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER RILPIVIRINHYDROCHLORID, OG EMTRICITABIN; REG. NO/DATE: EU/1/11/737/001-002 20111128

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