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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 patent protection?

Efavirenz is the generic ingredient in seven 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 fourteen NDAs. There are eighteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for efavirenz

US Patents:	18
Tradenames:	7
Applicants:	8
NDAs:	14
Drug Master File Entries:	26
Suppliers / Packagers:	8
Bulk Api Vendors:	79
Clinical Trials:	359
Patent Applications:	6,651
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for efavirenz
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	020972-003	Sep 17, 1998	AB	RX	Yes	Yes					Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998	AB	RX	Yes	Yes					Y
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998	AB	RX	Yes	No					Y
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998		DISCN	Yes	No					Y

Expired US Patents for efavirenz

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

International Patents for efavirenz

Country	Document Number	Estimated Expiration
South Korea	100573192
Eurasian Patent Organization	003217
United Kingdom	9706046
Japan	2011006472
Germany	69841972

Supplementary Protection Certificates for efavirenz

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00032	Netherlands		PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
0915894/02	Switzerland		PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
C0021	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
08/016	Ireland		PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
C/GB08/033	United Kingdom		PRODUCT 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