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Serving 500+ biopharmaceutical companies globally:

Merck
QuintilesIMS
Express Scripts
Deloitte
Boehringer Ingelheim
Argus Health
Moodys
Baxter
Covington
Chinese Patent Office

Generated: August 17, 2017

DrugPatentWatch Database Preview

GILEAD SCIENCES INC Company Profile

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

GILEAD SCIENCES INC has fifteen approved drugs.

There are fifty-six US patents protecting GILEAD SCIENCES INC drugs and there have been two Paragraph IV challenges on GILEAD SCIENCES INC drugs in the past three years.

There are one thousand three hundred and forty-two patent family members on GILEAD SCIENCES INC drugs in sixty-five countries.

Summary for Applicant: GILEAD SCIENCES INC

Patents:56
Tradenames:14
Ingredients:14
NDAs:15
Drug Master File Entries: (click here to view)7
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
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-004Jan 18, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
POWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
VITEKTA
elvitegravir
TABLET;ORAL203093-002Sep 24, 2014DISCNYesNo► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
ZYDELIG
idelalisib
TABLET;ORAL205858-001Jul 23, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Gilead Sciences Inc

Paragraph IV activity for GILEAD SCIENCES INC drugs

Drugname Dosage Strength Tradename Submissiondate
cobicistat
Tablets150 mg
TYBOST
12/9/2015
emtricitabine, rilpivirine, and tenofovir disoproxil fumarate
Tablets200 mg/25 mg/300 mg
COMPLERA
5/20/2015
tenofovir disoproxil fumarate
Tablets150 mg, 200 mg, and 250 mg
VIREAD
5/17/2012
tenofovir disoproxil fumarate
Tablets300 mg
VIREAD
1/26/2010

Non-Orange Book 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► Subscribe
9,206,217Nucleoside phosphoramidates► Subscribe
8,629,263Nucleoside phosphoramidates► Subscribe
8,383,655Modulators of pharmacokinetic properties of therapeutics► Subscribe
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Gilead Sciences Inc Drugs

Country Document Number Estimated Expiration
Canada2692331► Subscribe
Denmark1761540► Subscribe
New Zealand551839► Subscribe
Singapore10201702025S► Subscribe
World Intellectual Property Organization (WIPO)2013134288► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Gilead Sciences Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0780Netherlands► SubscribePRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
/2016Austria► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123
0867Netherlands► SubscribePRODUCT NAME: IDELALISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/938 20140919
0120010 00057Estonia► SubscribePRODUCT NAME: EDURANT - RILPIVIRIIN;REG NO/DATE: C(2011)8955 FINAL 28.11.2011
2017000008Germany► SubscribePRODUCT NAME: LDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 20140918
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKinsey
Fish and Richardson
Chinese Patent Office
Novartis
Colorcon
Cantor Fitzgerald
US Army
McKesson
AstraZeneca
Citi

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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