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Gilead Sciences Company Profile

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

GILEAD SCIENCES has twenty approved drugs.

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

There are one thousand eight hundred and forty-one patent family members on GILEAD SCIENCES drugs in sixty-eight countries and two hundred and sixty-five supplementary protection certificates in nineteen countries.

Summary for Gilead Sciences

International Patents:	1841
US Patents:	71
Tradenames:	17
Ingredients:	17
NDAs:	20
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	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes	10,548,846		Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-002	Aug 28, 2019		RX	Yes	Yes	8,618,076*PED				Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	8,716,264		Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No	9,284,342*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	10,039,718		Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes	8,633,309*PED				Y
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	AB	RX	Yes	No

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	5,663,169*PED
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	6,238,695
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	5,922,695*PED
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	5,814,639*PED
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	5,922,695*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	5,935,946*PED
Gilead Sciences Inc	VISTIDE	cidofovir	INJECTABLE;INJECTION	020638-001	Jun 26, 1996	5,142,051

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
Canada	3012242
Eurasian Patent Organization	201171417
European Patent Office	1789139
Mexico	2011008289
Japan	5911927
Lithuania	PA2015040
Japan	2013527145

Supplementary Protection Certificates for Gilead Sciences Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	12C0036	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE ET DE TENOFOVIR, EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
1663240	92853	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET L'EMTRICITABINE
1663240	300768	Netherlands		PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2487162	93352	Luxembourg		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVAT DE CELUI-CI ET DARUNAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SPLVAT DE CELUI-CI, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967
2487163	132017000002807	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E ATAZANAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE ATAZANAVIR SOLFATO(EVOTAZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1025, 20150715
2822954	33/2018	Austria		PRODUCT NAME: BICTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BICTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 (MITTEILUNG) 20180625
1761540	2017/006	Ireland		PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/14/938 20140918

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