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Last Updated: June 4, 2020

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EFAVIRENZ Drug Profile


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Which patents cover Efavirenz, and what generic alternatives are available?

Efavirenz is a drug marketed by Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Mylan, Strides Pharma, Teva Pharms Usa, and Macleods Pharms Ltd. and is included in twelve NDAs.

The generic ingredient in EFAVIRENZ is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.

Drug patent expirations by year for EFAVIRENZ
Drug Prices for EFAVIRENZ

See drug prices for EFAVIRENZ

Recent Clinical Trials for EFAVIRENZ

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

SponsorPhase
Allergan, plcPhase 2
Idorsia Pharmaceuticals Ltd.Phase 1
HeNan Sincere Biotech Co., LtdPhase 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

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-(S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one4-(trifluoromethyl)-2H-3,1-benzoxazin-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
ACM154801748
AK323634
AKOS015894951
AOB2950
API0002525
BCP27719
BCP9000636
BCPP000245
BDBM2483
BIDD:GT0383
C-19450
C08088
C14H9ClF3NO2
CAS-154598-52-4
CC-27439
CCG-101011
CHEBI:119486
CHEMBL223228
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
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
Eravirenz
FT-0625647
GP6354
HMS2051J08
HMS2090N16
HMS3393J08
HMS3713M14
HSDB 7163
HY-10572
J-520431
JE6H2O27P8
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
NC00261
NCGC00159337-02
NCGC00159337-04
NCGC00271713-05
NSC-742403
NSC742403
PubChem5812
Q422645
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
Aurobindo Pharma Ltd EFAVIRENZ efavirenz CAPSULE;ORAL 078064-001 Dec 15, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii EFAVIRENZ efavirenz TABLET;ORAL 078886-001 Apr 27, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd EFAVIRENZ efavirenz TABLET;ORAL 077673-001 Sep 21, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Moodys
Mallinckrodt
Medtronic
McKinsey

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