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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 seven branded drugs marketed by Aurobindo Pharma Ltd, Bristol Myers Squibb, Cipla, Hetero Labs Ltd Iii, Mylan, Strides Pharma, Gilead Sciences, Teva Pharms Usa, Macleods Pharms Ltd, and Mylan Labs Ltd, and is included in seventeen NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Efavirenz has thirty-five patent family members in twenty-six countries.

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

International Patents:	35
US Patents:	11
Tradenames:	7
Applicants:	10
NDAs:	17
Drug Master File Entries:	26
Suppliers / Packagers:	8
Bulk Api Vendors:	86
Clinical Trials:	379
Patent Applications:	5,982
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for efavirenz
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for efavirenz
DailyMed Link:	efavirenz at DailyMed

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

Synonyms for efavirenz

(-)-6-CHLORO-4-CYCLOPROPYLETHYNYL-4-TRIFLUOROMETHYL-1,4-DIHYDRO-2H-3,1-BENZOXAZIN-2-ONE

(4S)-6-chloranyl-4-(2-cyclopropylethynyl)-4-(trifluoromethyl)-1H-3,1-benzoxazin-2-one

(4S)-6-Chloro-4-(2-cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one

(4S)-6-chloro-4-(2-cyclopropylethynyl)-4-(trifluoromethyl)-1H-3,1-benzoxazin-2-one

(4S)-6-chloro-4-(2-cyclopropylethynyl)-4-(trifluoromethyl)-2,4-dihydro-1H-3,1-benzoxazin-2-one

(4S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one

(4S)-6-chloro-4-(cyclopropylethynyl)-4-(trifluoromethyl)-1,4-dihydro-2H-3,1-benzoxazin-2-one

(S)-6-Chloro-4-(cyclopropyl-ethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazine-2-one

(S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one

(S)-6-chloro-4-(cyclopropylethynyl)-4-(trifluoromethyl)-1,4-dihydro-2H-3,1-ben zoxazin-2-one

(S)-6-chloro-4-(cyclopropylethynyl)-4-(trifluoromethyl)-1,4-dihydro-2H-3,1-benzoxazin-2-one

(S)-6-chloro-4-(cyclopropylethynyl)-4-(trifluoromethyl)-1,4-dihydro-2H-benzo[d][1,3]oxazin-2-one

(S)-6-CHLORO-4-(CYCLOPROPYLETHYNYL)-4-(TRIFLUOROMETHYL)-1H-BENZO[D][1,3]OXAZIN-2(4H)-ONE

(s)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one

(S)-6-Chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-benzo[d][1,3]oxazin-2-one

(S)-Efavirenz

154598-52-4

1ikv

1ikw

2H-3, 6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-, (4S)-

2H-3,1-Benzoxazin-2-one, 6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-, (4S)-

598E524

6-chloro-4-(2-cyclopropyl-1-ethynyl)-4-trifluoromethyl-(4S)-1,4-dihydro-2H-benzo[d][1,3]oxazin-2-one

A809555

AB00639956-06

AB00639956-08

AB21723

AC-25006

AC1L20IX

ACM154801748

AKOS015894951

AOB2950

API0002525

BC214923

BCP27719

BCP9000636

BCPP000245

BDBM2483

BIDD:GT0383

C-19450

C08088

C14H9ClF3NO2

CAS-154598-52-4

CC-27439

CCG-101011

CHEBI:119486

CHEMBL223228

CJ-31514

CPD000466351

CS-2154

CTK8E9137

D00896

DB00625

DL-535

DMP 266

DMP-266

DMP-266; Efavirenz

DSSTox_CID_26029

DSSTox_GSID_46029

DSSTox_RID_81298

DTXSID9046029

E0997

Efavirenz (JAN/INN)

Efavirenz [USP:INN:BAN]

Efavirenz & IFNL1

Efavirenz & IFNL2

Efavirenz & IFNL3

Efavirenz & IL-28A

Efavirenz & IL-28B

Efavirenz & IL-29

Efavirenz & Interferon lambda-1

Efavirenz & Interferon lambda-2

Efavirenz & Interferon lambda-3

Efavirenz & Interleukin 28A

Efavirenz & Interleukin 28B

Efavirenz & Interleukin 29

Efavirenz & PLGA

Efavirenz & Poly-lactide-co-glycolide

Efavirenz solution, 1.0 mg/mL in acetonitrile, certified reference material

Efavirenz, (S)

efavirenz, (S)-isomer

Efavirenz, >=98% (HPLC)

Efavirenz, United States Pharmacopeia (USP) Reference Standard

Efavirenzum

EFV

EFV & IFNL1

EFV & IFNL2

EFV & IFNL3

EFV & IL-28A

EFV & IL-28B

EFV & IL-29

EFV & Interferon lambda-1

EFV & Interferon lambda-2

EFV & Interferon lambda-3

EFV & Interleukin 28A

EFV & Interleukin 28B

EFV & Interleukin 29

EFV & PLGA

EFZ

Eravirenz

FT-0625647

GP6354

HMS2051J08

HMS2090N16

HMS3393J08

HMS3713M14

HSDB 7163

HY-10572

J-520431

JE6H2O27P8

KB-50519

KS-00000ZEH

KS-00002WWM

KS-5380

L 743726

L-743,726

L-743725

L-743726

LS-173464

Met-SDF-1.beta. & Efavirenz

Met-Stromal Cell-derived Factor-1.beta. (Human) & Efavirenz

MFCD05662344

MLS000759465

MLS001424087

MolPort-003-983-924

NC00261

NCGC00159337-02

NCGC00159337-04

NCGC00271713-05

NSC-742403

NSC742403

PubChem5812

RL01986

RTX-012332

s4685

SAM001246667

SC-46515

SCHEMBL37762

SMR000466351

SR-01000759360

SR-01000759360-4

SR-01000759360-5

Stocrin

Strocin (TM)

Sustiva

Sustiva (TM)

Sustiva (TN)

Tox21_111582

Tox21_111582_1

UNII-JE6H2O27P8

XPOQHMRABVBWPR-ZDUSSCGKSA-N

Z2186909878

ZINC2020233

Generic filers with tentative approvals for EFAVIRENZ

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

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
Mylan	SYMFI LO	efavirenz; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	208255-001	Feb 5, 2018		RX	Yes	Yes
Aurobindo Pharma Ltd	EFAVIRENZ	efavirenz	TABLET;ORAL	205322-001	Aug 30, 2018	AB	RX	No	No
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes			Y
Aurobindo Pharma Ltd	EFAVIRENZ	efavirenz	CAPSULE;ORAL	078064-002	Dec 15, 2017		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	CAPSULE;ORAL	020972-002	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	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

International Patents for efavirenz

Country	Patent Number	Estimated Expiration
Slovakia	14612000
Czech Republic	300850
Taiwan	576741
Estonia	200000589

Supplementary Protection Certificates for efavirenz

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0582455	SPC/GB00/035	United Kingdom		PRODUCT 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
0582455	40/2000	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
0915894	C00915894/02	Switzerland		PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
0582455	C300032	Netherlands		PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528