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Last Updated: December 14, 2019

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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, 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-one tentative approvals for this compound.

Drug Prices for efavirenz

See drug prices for efavirenz

Recent Clinical Trials for efavirenz

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

SponsorPhase
CardiaBasePhase 3
University of CopenhagenPhase 3
University of MelbournePhase 3

See all efavirenz clinical trials

Recent Litigation for efavirenz

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK, SHARP & DOHME CORP. v. HETERO USA INC.2015-11-16
MERCK, SHARP & DOHME CORP. v. AUROBINDO PHARMA LTD.2013-09-11
MERCK, SHARP & DOHME CORP. v. HETERO USA INC.2013-03-07

See all efavirenz litigation

Generic filers with tentative approvals for EFAVIRENZ
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET; ORAL
  Start Trial  Start Trial200MGTABLET; ORAL
  Start Trial  Start Trial100MGTABLET; ORAL

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

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
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
Cipla EFAVIRENZ efavirenz TABLET;ORAL 204766-001 Jun 15, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-002 Feb 1, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998   Start Trial   Start Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for efavirenz

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0582455 SPC/GB08/022 United Kingdom   Start Trial PRODUCT 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
0582455 2008/016 Ireland   Start Trial PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0915894 08C0020 France   Start Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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