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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Argus Health
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Harvard Business School
Farmers Insurance
Johnson and Johnson
Cerilliant
Covington
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Cipla

Generated: September 25, 2017

DrugPatentWatch Database Preview

Efavirenz; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic drug sources for efavirenz; emtricitabine; tenofovir disoproxil fumarate and what is the scope of efavirenz; emtricitabine; tenofovir disoproxil fumarate patent protection?

Efavirenz; emtricitabine; tenofovir disoproxil fumarate
is the generic ingredient in one branded drug marketed by Gilead and is included in one NDA. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efavirenz; emtricitabine; tenofovir disoproxil fumarate has three hundred and ninety-nine patent family members in forty-seven countries.

There are twenty-five drug master file entries for efavirenz; emtricitabine; tenofovir disoproxil fumarate. Five suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Tradenames:1
Patents:15
Applicants:1
NDAs:1
Drug Master File Entries: see list25
Suppliers / Packagers: see list5
Clinical Trials: see list1,132
Drug Prices:see low prices
DailyMed Link:efavirenz; emtricitabine; tenofovir disoproxil fumarate at DailyMed

Tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe600MG; 200MG; 300MGTABLET; ORAL
► Subscribe► Subscribe600MG; 200MG; 300MGTABLET; ORAL
► Subscribe► Subscribe300MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Non-Orange Book Patents for Generic Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

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
6,812,233 Therapeutic nucleosides► Subscribe
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues► Subscribe
8,871,271Method and composition for pharmaceutical product► Subscribe
6,069,249 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability► Subscribe
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,276,151 Method of synthesis of 1,3-dioxolane nucleosides► Subscribe
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,210,085 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
5,965,729 Process for the crystallization of a reverse transcriptase inhibitor using an anti-solvent► Subscribe
7,402,588Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane► 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 Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Country Document Number Estimated Expiration
Hungary211344► Subscribe
Taiwan200711652► Subscribe
Norway324979► Subscribe
Singapore106656► Subscribe
Spain2345102► Subscribe
Denmark0574487► Subscribe
Austria419839► Subscribe
Japan4108645► Subscribe
Norway970386► Subscribe
Hong Kong1029793► 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 Tradename: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
178Luxembourg► Subscribe91178, EXPIRES: 20200221
0513200/01Switzerland► SubscribePRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
433Luxembourg► Subscribe91433, EXPIRES: 20220725
00032Netherlands► SubscribePRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
C/GB05/041United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
C021/2005Ireland► SubscribeSPC021/2005: 20090811, EXPIRES: 20200220
0915894/01Switzerland► SubscribePRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
6Finland► Subscribe
0915894/02Switzerland► SubscribePRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Dow
Harvard Business School
Argus Health
Julphar
Teva
Fuji
Fish and Richardson
Daiichi Sankyo
QuintilesIMS

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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