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Serving leading biopharmaceutical companies globally:

Deloitte
Chubb
Colorcon
Queensland Health
Cipla
Moodys
Merck
Cerilliant
Fuji
US Army

Generated: November 19, 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-four approved drugs.

There are eighty-five 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 eight hundred and five patent family members on GILEAD drugs in sixty-five countries and two hundred and one supplementary protection certificates in fifteen countries.

Summary for Gilead

International Patents:1805
US Patents:85
Tradenames:22
Ingredients:22
NDAs:24
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
ZYDELIG
idelalisib
TABLET;ORAL205858-001Jul 23, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-002Jan 18, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
VOSEVI
sofosbuvir; velpatasvir; voxilaprevir
TABLET;ORAL209195-001Jul 18, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
Gilead Sciences Inc
ZYDELIG
idelalisib
TABLET;ORAL205858-002Jul 23, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
ZYDELIG
idelalisib
TABLET;ORAL205858-001Jul 23, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Gilead Sciences Inc
ZYDELIG
idelalisib
TABLET;ORAL205858-002Jul 23, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Gilead

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006► Subscribe► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-003Mar 10, 2016► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007► Subscribe► Subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 2002► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007► Subscribe► Subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 2002► Subscribe► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007► Subscribe► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003► Subscribe► 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
emtricitabine
Capsules200 mg
EMTRIVA
7/16/2012
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
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
8,563,530Purine nucleoside phosphoramidate► Subscribe
9,221,833Antiviral compounds► Subscribe
9,345,663Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections► Subscribe
RE42477Carboxylic acid derivatives, their preparation and use► Subscribe
8,486,942Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,669,234Antiviral compounds► Subscribe
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
9,156,823Antiviral compounds► Subscribe
8,653,077Inhibitors of human phosphatidylinositol 3-kinase delta► 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
San MarinoT201600351► Subscribe
World Intellectual Property Organization (WIPO)0181346► Subscribe
South Korea101560994► Subscribe
Mexico2014015846► Subscribe
Hong Kong1145449► Subscribe
Singapore11201408739V► Subscribe
Canada2577288► Subscribe
Costa Rica20130231► Subscribe
Canada2915187► Subscribe
Ukraine67793► 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
0513200/01Switzerland► SubscribePRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
853Luxembourg► 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 ET L'EMTRICITABINE
2015035Lithuania► SubscribePRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
70036Netherlands► SubscribePRODUCT NAME: CIDOFOVIR,DESGEWENST IN DE VORM VAN EEN ZOUT MET AMMONIA,EEN ALKALIMETAAL OF EEN AMINE; REGISTRATION NO/DATE: EU/1/97/037/001 19970423
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
C0013France► SubscribePRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
/2015Austria► SubscribePRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
C0034France► SubscribePRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
1564210/01Switzerland► SubscribePRODUCT NAME: ELVITEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 62673 18.10.2013
0160017 00199Estonia► SubscribePRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
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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
Baxter
Johnson and Johnson
Moodys
Boehringer Ingelheim
Daiichi Sankyo
UBS
Merck
Express Scripts
Teva

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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