DrugPatentWatch Database Preview

GILEAD SCIENCES INC Company Profile

« Back to Dashboard

What is the competitive landscape for GILEAD SCIENCES INC, and when can generic versions of GILEAD SCIENCES INC drugs launch?

GILEAD SCIENCES INC has seventeen approved drugs.

There are sixty-seven US patents protecting GILEAD SCIENCES INC drugs.

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

Summary for GILEAD SCIENCES INC

International Patents:	1522
US Patents:	67
Tradenames:	16
Ingredients:	16
NDAs:	17
Drug Master File Entries:	7
Patent Litigation for GILEAD SCIENCES INC:	See patent lawsuits for GILEAD SCIENCES INC

Drugs and US Patents for GILEAD SCIENCES INC

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	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	7,176,220		Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	8,138,195		Y	Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	6,043,230*PED
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No	7,176,220		Y	Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,716,264		Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	8,334,270		Y	Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016		RX	Yes	Yes	7,390,791		Y	Y

Expired US Patents for GILEAD SCIENCES INC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	5,935,946*PED
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	5,914,331*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	4,808,716
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	6,043,230*PED
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	5,914,331*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	5,977,089*PED

Paragraph IV (Patent) Challenges for GILEAD SCIENCES INC 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, 200 mg, and 250 mg		2012-05-17
	Tablets	150 mg		2015-12-09

Non-Orange Book US Patents for GILEAD SCIENCES INC

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,728,575	Method of resolution of 1,3-oxathiolane nucleoside enantiomers
7,939,553	Modulators of pharmacokinetic properties of therapeutics
9,156,823	Antiviral compounds
9,051,340	Antiviral compounds
8,735,569	Nucleoside phosphoramidates
8,486,942	Modulators of pharmacokinetic properties of therapeutics
RE38333	Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability

International Patents for GILEAD SCIENCES INC Drugs

Country	Document Number	Estimated Expiration
South Africa	200601820
Philippines	12014502771
Japan	2015512860
Mexico	2012011324
South Korea	20170060179
Mexico	PA06002437
Portugal	2873665

Supplementary Protection Certificates for GILEAD SCIENCES INC Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0867	Netherlands		PRODUCT NAME: IDELALISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/938 20140919
2016000024	Germany		PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
90002-9	Sweden		PRODUCT NAME: ; REG. NO/DATE: EU/1/14/958 20141118
90003-6	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REG. NO/DATE: EU/1/14/967 20141121
1564210/01	Switzerland		PRODUCT NAME: ELVITEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 62673 18.10.2013
C/GB08/033	United Kingdom		PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715

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