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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 five branded drugs marketed by Aurobindo Pharma Ltd, Bristol Myers Squibb, Cipla Ltd, Hetero Labs Ltd Iii, Mylan Pharms Inc, Strides Pharma, Gilead Sciences, and Mylan Labs Ltd, and is included in ten 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.

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

Summary for efavirenz

International Patents:	77
US Patents:	18
Tradenames:	5
Applicants:	8
NDAs:	10
Drug Master File Entries:	26
Suppliers / Packagers:	9
Bulk Api Vendors:	80
Clinical Trials:	359
Patent Applications:	6,554
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for efavirenz
DailyMed Link:	efavirenz at DailyMed

Pharmacology for efavirenz

Ingredient-type	Non-Nucleoside Analog
Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C9 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inhibitors

Tentative approvals for EFAVIRENZ

Applicant	Application No.	Strength	Dosage Form
		600MG; 300MG; 300MG	TABLET; ORAL
		600MG; 300MG; 300MG	TABLET; ORAL
		200MG	TABLET; ORAL

US Patents and Regulatory Information for efavirenz

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;ORAL	020972-001	Sep 17, 1998	AB	RX	Yes	No					Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		RX	Yes	Yes			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		RX	Yes	Yes
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998		DISCN	Yes	No					Y

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Expired US Patents for efavirenz

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-002	Feb 1, 2002
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-002	Feb 1, 2002
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998

Non-Orange Book US Patents for 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

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International Patents for efavirenz

Country	Document Number	Estimated Expiration
Brazil	9908810
Hungary	228498
Taiwan	576741
Czech Republic	300850

Supplementary Protection Certificates for efavirenz

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
01C/001	Belgium		PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0915894/02	Switzerland		PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
/2000	Austria		PRODUCT 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