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Serving leading biopharmaceutical companies globally:

Deloitte
Teva
Dow
AstraZeneca
Farmers Insurance
Fuji
Harvard Business School
US Army
Julphar
Healthtrust

Generated: October 22, 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-three patent family members on GILEAD SCIENCES INC drugs in sixty-five countries and one hundred and fifty-eight supplementary protection certificates in fifteen countries.

Summary for Applicant: GILEAD SCIENCES INC

International Patents:1423
US Patents:60
Tradenames:15
Ingredients:15
NDAs:16
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
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-004Jan 18, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
POWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
VITEKTA
elvitegravir
TABLET;ORAL203093-001Sep 24, 2014DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-002Jan 18, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
VITEKTA
elvitegravir
TABLET;ORAL203093-002Sep 24, 2014DISCNYesNo► Subscribe► Subscribe► 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 Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015► Subscribe► Subscribe
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001► Subscribe► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016► Subscribe► Subscribe
Gilead Sciences Inc
VISTIDE
cidofovir
INJECTABLE;INJECTION020638-001Jun 26, 1996► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001► Subscribe► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011► Subscribe► Subscribe
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016► Subscribe► Subscribe
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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
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
9,156,823Antiviral compounds► Subscribe
9,655,944Inhibitors of hepatitis C virus► Subscribe
9,139,541Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,642,756Nucleoside phosphoramidates► Subscribe
6,931,679 Foldable stand for a hammock► Subscribe
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► Subscribe
7,932,260Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta► Subscribe
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane► Subscribe
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► 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
Germany60329318► Subscribe
Hong Kong1145449► Subscribe
CroatiaP20140667► Subscribe
European Patent Office2933260► Subscribe
Japan2013525277► Subscribe
Luxembourg92008► Subscribe
African Regional IP Organization (ARIPO)201206543► Subscribe
Hong Kong1026419► Subscribe
Ukraine101312► Subscribe
Japan2015523365► 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
00704Netherlands► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
0861Netherlands► SubscribePRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121
0513200/01Switzerland► SubscribePRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
3 5021-2015Slovakia► SubscribePRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
2016042Lithuania► SubscribePRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
5 5007-2012Slovakia► SubscribePRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
6Finland► Subscribe
0150041 00168Estonia► SubscribePRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
2016000024Germany► SubscribePRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
600Luxembourg► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
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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 leading biopharmaceutical companies globally:

Chinese Patent Office
Chubb
McKesson
Healthtrust
Cantor Fitzgerald
Cerilliant
Baxter
US Department of Justice
McKinsey
Colorcon

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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