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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 patent protection?

Efavirenz is the generic ingredient in seven branded drugs marketed by Aurobindo Pharma Ltd, Bristol Myers Squibb, Cipla, Hetero Labs Ltd Iii, Mylan, Strides Pharma, Gilead Sciences, Teva Pharms Usa, Laurus Labs Ltd, Macleods Pharms Ltd, and Mylan Labs Ltd, and is included in nineteen NDAs. There are nine 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. Nine suppliers are listed for this compound. There are twenty-one tentative approvals for this compound.

Summary for efavirenz

US Patents:	9
Tradenames:	7
Applicants:	11
NDAs:	19
Drug Master File Entries:	26
Suppliers / Packagers:	9
Bulk Api Vendors:	91
Clinical Trials:	394
Patent Applications:	7,193
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for efavirenz
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for efavirenz
What excipients (inactive ingredients) are in efavirenz?	efavirenz excipients list
DailyMed Link:	efavirenz at DailyMed

See drug prices for efavirenz

Recent Clinical Trials for efavirenz

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 4
Allergan, plc	Phase 2
Jiangsu HengRui Medicine Co., Ltd.	Phase 1

See all efavirenz clinical trials

Generic filers with tentative approvals for EFAVIRENZ

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET; ORAL
		200MG	TABLET; ORAL
		100MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for efavirenz

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

Paragraph IV (Patent) Challenges for EFAVIRENZ

Tradename	Dosage	Ingredient	NDA	Submissiondate
SUSTIVA	CAPSULE;ORAL	efavirenz	020972	2016-11-03
SUSTIVA	TABLET;ORAL	efavirenz	021360	2009-04-09

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
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes
Cipla	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	206894-001	Jun 3, 2019	AB	RX	No	No
Laurus Labs Ltd	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	212786-001	May 14, 2020	AB	RX	No	No

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	CAPSULE;ORAL	020972-003	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998