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Efavirenz; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for efavirenz; emtricitabine; tenofovir disoproxil fumarate?

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 eighty-nine patent family members in forty-seven countries.

There are twenty-four drug master file entries for efavirenz; emtricitabine; tenofovir disoproxil fumarate. Six 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 list24
Suppliers / Packagers: see list6
Clinical Trials: see list436
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. Form Dosage
► Subscribe► SubscribeTABLET; ORAL600MG; 200MG; 300MG
► Subscribe► SubscribeTABLET; ORAL600MG; 200MG; 300MG
► Subscribe► SubscribeTABLET; ORAL600MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes5,977,089*PED► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes5,935,946*PED► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes6,939,964*PED► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes6,703,396*PED► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes9,545,414► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,210,085*PED► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20067,402,588*PED► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,519,021*PED► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,814,639*PED► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,811,423► Subscribe
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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
5,914,400 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
7,053,100Therapeutic nucleosides► Subscribe
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
8,871,271Method and composition for pharmaceutical product► 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 Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Country Document Number Estimated Expiration
Hong Kong1051360► Subscribe
New Zealand501287► Subscribe
Australia713374► Subscribe
Ireland920545► Subscribe
Japan3987335► 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
0915894/01Switzerland► SubscribePRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
433Luxembourg► Subscribe91433, EXPIRES: 20220725
0148Netherlands► Subscribe300148, 20110131, EXPIRES: 20160130
C0021France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
6Finland► Subscribe
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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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