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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
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Johnson and Johnson
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Covington
Argus Health
Healthtrust
Mallinckrodt
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Generated: September 21, 2017

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Efavirenz - Generic Drug Details

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What are the generic drug sources for efavirenz and what is the scope of efavirenz freedom to operate?

Efavirenz
is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Mylan Pharms Inc, and Gilead, and is included in four NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efavirenz has seventy-two patent family members in twenty-seven countries.

There are twenty-five drug master file entries for efavirenz. Three suppliers are listed for this compound. There are twenty-eight tentative approvals for this compound.

Summary for Generic Name: efavirenz

Tradenames:3
Patents:17
Applicants:3
NDAs:4
Drug Master File Entries: see list25
Suppliers / Packagers: see list3
Bulk Api Vendors: see list55
Clinical Trials: see list358
Patent Applications: see list5,336
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:efavirenz at DailyMed

Tentative approvals for EFAVIRENZ

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe600MG; 300MG; 300MGTABLET; ORAL
► Subscribe► Subscribe600MG; 300MG; 300MGTABLET; ORAL
► Subscribe► Subscribe200MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 1998RXYesYes► Subscribe► SubscribeY► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 2002ABRXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-002Sep 17, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 1998RXYesNo► Subscribe► Subscribe► 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
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 1998RXYesNo► 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

Non-Orange Book Patents for Generic Ingredient: efavirenz

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
5,965,729 Process for the crystallization of a reverse transcriptase inhibitor using an anti-solvent► 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

Country Document Number Estimated Expiration
Israel130715► Subscribe
Japan6126172► Subscribe
Hungary0101517► Subscribe
Ukraine72207► Subscribe
China1246113► Subscribe
Slovakia105599► Subscribe
Czech Republic297535► Subscribe
Czech Republic20003571► Subscribe
Estonia03827► Subscribe
Australia6263298► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
08/016Ireland► SubscribePRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
C/GB08/033United Kingdom► SubscribePRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
0915894/02Switzerland► SubscribePRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
C/GB00/035United Kingdom► SubscribePRODUCT NAME: EFAVIRENZ, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH IKS-54 908 01 19981120; CH IKS-54 908 02 19981120; CH IKS-54 908 03 19981120; UK EU/1/99/110/001 19990528; UK EU/1/99/110/002 19990528; UK EU/1/99/110/003 19990528; UK EU/1/99/110/004 19990528; UK EU/1/99/111/001 19990528; UK EU/1/99/111/002 19990528; UK EU/1/99/111/003 19990528; UK EU/1/99/111/004 19990528
01C/001Belgium► SubscribePRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
/2000Austria► SubscribePRODUCT NAME: EFAVIRENZ, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/99/110/001-004 1/99/111/001-004 19990528; FIRST REGISTRATION: LI 54908 01, 54908 02, 54908 03 19981120
C0021France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
C/GB08/022United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213
00032Netherlands► SubscribePRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Baxter
Accenture
QuintilesIMS
Chinese Patent Office
Cerilliant
Federal Trade Commission
Fish and Richardson
Boehringer Ingelheim
Cipla
Farmers Insurance

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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