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Generated: December 17, 2018

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SUSTIVA Drug Profile

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When do Sustiva patents expire, and when can generic versions of Sustiva launch?

Sustiva is a drug marketed by Bristol Myers Squibb and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has seventy-seven patent family members in twenty-eight countries.

The generic ingredient in SUSTIVA is efavirenz. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the efavirenz profile page.

Drug patent expirations by year for SUSTIVA
Synonyms for SUSTIVA
(-)-6-CHLORO-4-CYCLOPROPYLETHYNYL-4-TRIFLUOROMETHYL-1,4-DIHYDRO-2H-3,1-BENZOXAZIN-2-ONE
(-)-Efavirenz
(4S)-?6-?CHLORO-?4-?(2-?CYCLOPROPYLETHYNYL)-?1,?4-?DIHYDRO-?4-?(TRIFLUOROMETHYL)-?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
(4S)-6-Chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-benzo[d][1,3]oxazin-2-one
(S)-6-Chloro-4-(2-cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-ben
(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-(2-cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-, (4S)-
2H-3,1-Benzoxazin-2-one, 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)-(9
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
AK323634
AKOS015894951
AOB2950
API0002525
BC214923
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
D07HVY
DB00625
DL-535
DMP 266
DMP-266
DR001359
DSSTox_CID_26029
DSSTox_GSID_46029
DSSTox_RID_81298
DTXSID9046029
E0997
efavirenz
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
ent Efavirenz
Eravirenz
FT-0625647
GP6354
HE233205
HMS2051J08
HMS2090N16
HMS3393J08
HSDB 7163
HY-10572
J-520431
JE6H2O27P8
KB-50519
KS-00000ZEH
KS-00002WWM
KS-5380
L 743726
L-741211
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
NSC-742403
NSC742403
PubChem5812
RL01986
RTX-012332
s4685
SAM001246667
SBB066062
SC-46515
SCHEMBL37762
SMR000466351
Stocrin
Stocrin (TN)
Strocin (TM)
Sustiva (TM)
Sustiva (TN)
Tox21_111582
Tox21_111582_1
UNII-JE6H2O27P8
XPOQHMRABVBWPR-ZDUSSCGKSA-N
Z2186909878
ZINC2020233
zoxazin-2-one

US Patents and Regulatory Information for SUSTIVA

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 020972-001 Sep 17, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free 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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Expired US Patents for SUSTIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for SUSTIVA
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 50 mg, 100 mg and 200 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 600 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for SUSTIVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/033 United Kingdom ➤ Try a Free Trial 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
/2000 Austria ➤ Try a Free Trial 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
00032 Netherlands ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
01C/001 Belgium ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
McKesson
Colorcon
US Army
Julphar
Merck
US Department of Justice
Healthtrust
Cipla

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