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Serving 500+ biopharmaceutical companies globally:

Julphar
Colorcon
Moodys
Boehringer Ingelheim
Farmers Insurance
McKinsey
Harvard Business School
Medtronic
US Department of Justice
Cerilliant

Generated: July 22, 2017

DrugPatentWatch Database Preview

Gilead Company Profile

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What is the competitive landscape for GILEAD, and what generic alternatives to GILEAD drugs are available?

GILEAD has twenty-three approved drugs.

There are eighty-one US patents protecting GILEAD drugs and there have been four Paragraph IV challenges on GILEAD drugs in the past three years.

There are one thousand seven hundred patent family members on GILEAD drugs in sixty-five countries.

Summary for Applicant: Gilead

Patents:81
Tradenames:21
Ingredients:21
NDAs:23
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
VITEKTA
elvitegravir
TABLET;ORAL203093-001Sep 24, 2014DISCNYesNo► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-003Jan 18, 2012RXYesNo5,977,089*PED► SubscribeY► Subscribe
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes5,935,946*PED► SubscribeY► Subscribe
Gilead Sciences Inc
VEMLIDY
tenofovir alafenamide fumarate
TABLET;ORAL208464-001Nov 10, 2016RXYesYes9,296,769► SubscribeYY ► Subscribe
Gilead Sciences Inc
ZYDELIG
idelalisib
TABLET;ORAL205858-001Jul 23, 2014RXYesNoRE44599► Subscribe ► Subscribe
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Expired Patents for Gilead

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 20078,349,843► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 20064,567,264► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 20014,808,716► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,210,085*PED► Subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 20024,724,233► Subscribe
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Paragraph IV activity for GILEAD drugs

Drugname Dosage Strength Tradename Submissiondate
emtricitabine and tenofovir disoproxil fumarate
Tablets100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mg
TRUVADA
5/19/2017
cobicistat
Tablets150 mg
TYBOST
12/9/2015
emtricitabine, rilpivirine, and tenofovir disoproxil fumarate
Tablets200 mg/25 mg/300 mg
COMPLERA
5/20/2015
ambrisentan
Tablets5 mg and 10 mg
LETAIRIS
2/9/2015
tenofovir disoproxil fumarate
Tablets150 mg, 200 mg, and 250 mg
VIREAD
5/17/2012
adefovir dipivoxil
Tablets10 mg
HEPSERA
6/8/2010
tenofovir disoproxil fumarate
Tablets300 mg
VIREAD
1/26/2010
efavirenz, emtricitabine and tenofovir disoproxil fumarate
Tablets600 mg/200 mg/300 mg
ATRIPLA
12/29/2008
emtricitabine and tenofovir disoproxil fumarate
Tablets200 mg/300 mg
TRUVADA
9/26/2008

Non-Orange Book Patents for Gilead

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
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
7,402,588Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane► Subscribe
8,629,263Nucleoside phosphoramidates► Subscribe
RE42477Carboxylic acid derivatives, their preparation and use► Subscribe
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► 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 Drugs

Country Document Number Estimated Expiration
Japan2017057232► Subscribe
Philippines12015502237► Subscribe
India190780► Subscribe
Taiwan577880► Subscribe
Israel141892► 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 Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004Austria► SubscribePRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
2016038Lithuania► SubscribePRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
008Luxembourg► Subscribe92008, EXPIRES: 20261128
4 5022-2015Slovakia► SubscribePRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
1353647/01Switzerland► SubscribePRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010
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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:

QuintilesIMS
Medtronic
Baxter
Farmers Insurance
Mallinckrodt
Deloitte
Cerilliant
US Department of Justice
Federal Trade Commission
Julphar

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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