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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 eighteen approved drugs.

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

Summary for Gilead Sciences

US Patents:	74
Tradenames:	17
Ingredients:	17
NDAs:	18
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	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	8,980,901
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	8,618,076		Y	Y
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	AB	RX	Yes	No	5,977,089*PED
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	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes	8,841,278		Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	9,149,477
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes	8,598,185		Y

Expired US Patents for Gilead Sciences

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	6,043,230*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	5,922,695*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012	5,977,089*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	6,043,230*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	5,935,946*PED
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	5,922,695*PED
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	5,814,639*PED

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	600 mg/200 mg/300 mg		2008-12-29
	Tablets	150 mg, 200 mg, and 250 mg		2012-05-17
	Tablets	150 mg		2015-12-09

International Patents for Gilead Sciences Drugs

Country	Document Number	Estimated Expiration
Australia	2010249481
European Patent Office	2952181
Singapore	155885
Spain	2601820
Denmark	2552930
Finland	121069
Eurasian Patent Organization	201690461

Supplementary Protection Certificates for Gilead Sciences Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015 00056	Denmark		PRODUCT NAME: CERTIFIKAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
2016 00006	Denmark		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
00704	Netherlands		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
3 5021-2015	Slovakia		PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
0120012 00058	Estonia		PRODUCT NAME: EVIPLERA - EMTRITSITABIIN/RILPIVIRIIN (HUEDRO-;REG NO/DATE: C(2011)8956 FINAL 28.11.2011
90002-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715
90001-0	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123

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