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Serving leading biopharmaceutical companies globally:

Merck
Cipla
Mallinckrodt
Argus Health
McKinsey
Chinese Patent Office
Covington
Julphar
US Department of Justice
Cantor Fitzgerald

Generated: December 13, 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 sixteen approved drugs.

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

Summary for GILEAD SCIENCES INC

International Patents:1420
US Patents:60
Tradenames:15
Ingredients:15
NDAs:16
Drug Master File Entries: 7
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences IncCOMPLERAemtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarateTABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncZYDELIGidelalisibTABLET;ORAL205858-001Jul 23, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncGENVOYAcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarateTABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-001Oct 26, 2001ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncHARVONIledipasvir; sofosbuvirTABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncZYDELIGidelalisibTABLET;ORAL205858-001Jul 23, 2014RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Patents for Gilead Sciences Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences IncVISTIDEcidofovirINJECTABLE;INJECTION020638-001Jun 26, 1996► Subscribe► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016► Subscribe► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-001Oct 26, 2001► Subscribe► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-001Oct 26, 2001► Subscribe► Subscribe
Gilead Sciences IncGENVOYAcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarateTABLET;ORAL207561-001Nov 5, 2015► Subscribe► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012► Subscribe► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016► Subscribe► Subscribe
Gilead Sciences IncCOMPLERAemtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarateTABLET;ORAL202123-001Aug 10, 2011► Subscribe► Subscribe
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Paragraph IV activity for GILEAD SCIENCES INC drugs

Drugname Dosage Strength Tradename Submissiondate
cobicistatTablets150 mgTYBOST12/9/2015
emtricitabine, rilpivirine, and tenofovir disoproxil fumarateTablets200 mg/25 mg/300 mgCOMPLERA5/20/2015
tenofovir disoproxil fumarateTablets150 mg, 200 mg, and 250 mgVIREAD5/17/2012
tenofovir disoproxil fumarateTablets300 mgVIREAD1/26/2010

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
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,931,679 Foldable stand for a hammock► Subscribe
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
7,468,436Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
9,156,823Antiviral compounds► Subscribe
8,088,770Modulators of pharmacokinetic properties of therapeutics► Subscribe
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► Subscribe
8,067,449Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,859,756Stereoselective synthesis of phosphorus containing actives► Subscribe
8,383,655Modulators of pharmacokinetic properties of therapeutics► 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
Japan2016104823► Subscribe
Moldova, Republic of4430► Subscribe
Spain2602784► Subscribe
Japan4642309► Subscribe
Australia665187► Subscribe
Israel241732► Subscribe
South Korea20060090658► Subscribe
Argentina042095► Subscribe
Portugal2640719► Subscribe
China104016971► 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
C/GB97/083United Kingdom► SubscribePRODUCT NAME: CIDOFOVIR; REGISTERED: UK EU/1/97/037/001 19970423
2016000109Germany► SubscribePRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN. EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
00624Netherlands► SubscribePRODUCT NAME: ELVITEGRAVIR IN ALLE VORMEN ZOALS; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
2013 00058Denmark► SubscribePRODUCT NAME: ELVITEGRAVIR ELLER ET HYDRAT, ET SOLVAT, EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
855Luxembourg► SubscribePRODUCT 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 , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
0915894/01Switzerland► SubscribePRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
2015 00060Denmark► SubscribePRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
C018/2008Ireland► SubscribeSPC018/2008: 20090811, EXPIRES: 20220724
C/GB04/016United Kingdom► SubscribePRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
2016 00012Denmark► SubscribePRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
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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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Covington
Boehringer Ingelheim
Federal Trade Commission
Novartis
Mallinckrodt
Citi
QuintilesIMS
McKinsey
Daiichi Sankyo

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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