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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Julphar
Colorcon
Fuji
Merck
Moodys
Accenture
Mallinckrodt
Boehringer Ingelheim
Citi

Generated: September 25, 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-three 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 and seventy-eight patent family members on GILEAD drugs in sixty-five countries.

Summary for Applicant: Gilead

Patents:83
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
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-003Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeYY ► 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
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
POWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Gilead

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
9,051,340Antiviral compounds► Subscribe
8,486,942Modulators of pharmacokinetic properties of therapeutics► Subscribe
6,197,958 Carboxylic acid derivatives, their preparation and use► Subscribe
8,349,843Carboxylic acid derivatives, their preparation and use► Subscribe
8,642,756Nucleoside phosphoramidates► Subscribe
9,533,000Inhalable aztreonam for treatment and prevention of pulmonary bacterial infections► Subscribe
8,669,234Antiviral compounds► Subscribe
7,119,097Carboxylic acid derivatives, their preparation and their use► Subscribe
9,238,070Therapies for hematologic malignancies► Subscribe
7,956,063Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile► 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
South Korea20150056665► Subscribe
Luxembourg93081► Subscribe
Spain2438275► Subscribe
Slovenia2487161► Subscribe
Austria472537► Subscribe
Hong Kong1091212► Subscribe
Japan2010512414► Subscribe
BrazilPI1012781► Subscribe
New Zealand610525► Subscribe
South Korea20040081443► 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
0813Netherlands► SubscribePRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
178Luxembourg► Subscribe91178, EXPIRES: 20200221
2013 00058Denmark► SubscribePRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524
2017 00002Denmark► SubscribePRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121
C0035France► SubscribePRODUCT NAME: RILPIVIRINE AINSI QUE SES FORMES THERAPEUTIQUEMENT PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION DE RILPIVIRINE PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
2015040Lithuania► SubscribePRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
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
2016000110Germany► SubscribePRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2015000092Germany► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
1419152/01Switzerland► SubscribePRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: SWISSMEDIC 61548 26.02.2013
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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:

Novartis
Baxter
Queensland Health
Harvard Business School
Teva
QuintilesIMS
Farmers Insurance
US Army
Merck
Express Scripts

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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ISSN: 2162-2639

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