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Serving leading biopharmaceutical companies globally:

Dow
Cantor Fitzgerald
Federal Trade Commission
Express Scripts
Merck
Moodys
Deloitte
Baxter
QuintilesIMS
Covington

Generated: December 16, 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 eighteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Efavirenz has seventy-seven patent family members in twenty-eight countries and ten supplementary protection certificates in 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.

Tentative approvals for EFAVIRENZ

Applicant Application No. Strength Dosage Form
u► Subscribe600MG; 300MG; 300MGTABLET; ORAL
u► Subscribe600MG; 300MG; 300MGTABLET; ORAL
u► 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 SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-002Sep 17, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-002Sep 17, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-002Sep 17, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-002Sep 17, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
GileadATRIPLAefavirenz; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-003Sep 17, 1998RXYesYes► Subscribe► SubscribeY► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-001Sep 17, 1998RXYesNo► Subscribe► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-001Sep 17, 1998RXYesNo► Subscribe► SubscribeY► Subscribe
GileadATRIPLAefavirenz; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
GileadATRIPLAefavirenz; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: efavirenz

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-002Sep 17, 1998► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-001Sep 17, 1998► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-003Sep 17, 1998► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-002Sep 17, 1998► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-003Sep 17, 1998► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzTABLET;ORAL021360-001Feb 1, 2002► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzTABLET;ORAL021360-002Feb 1, 2002► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzTABLET;ORAL021360-001Feb 1, 2002► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzTABLET;ORAL021360-002Feb 1, 2002► Subscribe► Subscribe
Bristol Myers SquibbSUSTIVAefavirenzCAPSULE;ORAL020972-003Sep 17, 1998► Subscribe► Subscribe
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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
Slovakia105599► Subscribe
China1146419► Subscribe
China1296412► Subscribe
Canada2321523► Subscribe
Taiwan576741► Subscribe
Czech Republic20003571► Subscribe
Brazil9908810► Subscribe
Australia6263298► Subscribe
Austria486065► Subscribe
Japan2002510634► 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
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; 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
00032Netherlands► SubscribePRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
/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
0915894/02Switzerland► SubscribePRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
01C/001Belgium► SubscribePRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
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
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
C0021France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
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
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Serving leading biopharmaceutical companies globally:

McKesson
Teva
Citi
Healthtrust
Argus Health
Covington
Cerilliant
McKinsey
Baxter
US Department of Justice

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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