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Last Updated: January 17, 2020

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ABACAVIR SULFATE Drug Profile

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Which patents cover Abacavir Sulfate, and when can generic versions of Abacavir Sulfate launch?

Abacavir Sulfate is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, Teva Pharms Usa, and Zydus Pharms. and is included in fifteen NDAs.

The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

Drug patent expirations by year for ABACAVIR SULFATE
Recent Clinical Trials for ABACAVIR SULFATE

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

SponsorPhase
Cynthia L Gay, MDN/A
National Cancer Institute (NCI)N/A
ViiV HealthcareN/A

See all ABACAVIR SULFATE clinical trials

Recent Litigation for ABACAVIR SULFATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan Inc. v. Alcon Inc.2004-08-24

See all ABACAVIR SULFATE litigation

Synonyms for ABACAVIR SULFATE
((1S,4R)-4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)cyclopent-2-en-1-yl)methanol hemisulfate
((1s,4r)-4-(2-amino-6-(cyclopropylamino)-9h-purin-9-yl)cyclopent-2-enyl)methanol
(+/-)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol
(+/-)-Abacavir
(+/-)-cis-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol
(1S,4R)-4-(2-Amino-6-(cyclopropylamino)-9H-purin-9-yl)-2-cyclopentene-1-methanol sulfate (salt) (2:1)
(1S,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol
(1S,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate
[(1S,4R)-4-[2-amino-6-(cyclopropylamino)-9-purinyl]-1-cyclopent-2-enyl]methanol
[(1S,4R)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopent-2-en-1-yl]methanol
[(1s,4r)-4-[2-amino-6-(cyclopropylamino)purin-9-yl]-1-cyclopent-2-enyl]methanol
[(1S,4R)-4-[2-amino-6-(cyclopropylamino)purin-9-yl]cyclopent-2-en-1-yl]methanol
[(1S,4R)-4-[2-amino-6-(cyclopropylamino)purin-9-yl]cyclopent-2-en-1-yl]methanol; sulfuric acid
[(1S,4R)-4-[2-amino-6-(cyclopropylamino)purin-9-yl]cyclopent-2-en-1-yl]methanol;sulfuric acid
[(1S,4R)-4-[2-azanyl-6-(cyclopropylamino)purin-9-yl]cyclopent-2-en-1-yl]methanol
{(1S-cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopent-2-en-1-yl}methanol
{(1S,4R)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopent-2-en-1-yl}methanol
136470-78-5
136470-78-5 (Succinate)
136777-48-5
1423331-68-3
1592U89
1592U89 sulfate
188062-50-2
2-Cyclopentene-1-methanol, 4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)-, (1S-cis)-
2-Cyclopentene-1-methanol, 4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)-, (1S,4R)-
2-Cyclopentene-1-methanol, 4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)-, (1S,4R)-, rel-, sulfate (2:1)
2-Cyclopentene-1-methanol, 4-(2-Amino-6-(cyclopropylamino)-9H-purin-9-yl)-, sulfate (salt)(2:1), (1S,4R)-
2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1S,4R)-, sulfate (2:1)
2-Cyclopentene-1-methanol,4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-,hydrochloride (1:1), (1S,4R)-
2-Cyclopentene-1-methanol,4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-,hydrochloride(1:1),(1S,4R)-
470A785
777A485
A807079
AB01566826_01
AB17664
abacavir
Abacavir (INN)
Abacavir (sulfate)
Abacavir [INN:BAN]
Abacavir Hemisulfate
Abacavir sulfate (JAN/USAN)
Abacavir sulfate [USAN:USP]
Abacavir sulfate, (+/-)-
Abacavir sulfate, >=98% (HPLC)
Abacavir sulphate
AC-1299
AC-6112
AC1L9AXG
AC1L9B2P
ACT03218
AK163479
AKOS015994684
AKOS024464970
AKOS025402202
AS-17843
BC214924
BCP07728
BDBM50366816
bis(((1S,4R)-4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)cyclopent-2-en-1-yl)methanol) sulfate
bis([(1S,4R)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopent-2-en-1-yl]methanol); sulfuric acid
bis({(1S,4R)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopent-2-en-1-yl}methanol) sulfate
C-18039
C07624
C28H38N12O6S
CC-23613
CCG-220902
CHEBI:2361
CHEBI:421707
CHEMBL1200619
CHEMBL1380
CJ-31308
CS-1354
CS-2023
D00891
D07057
DB01048
EN300-258000
Epitope ID:137341
FT-0621705
FT-0631153
FT-0660941
HMS3714F06
HSDB 7154
HY-17423
HY-17423A
J-700136
J-700139
J220T4J9Q2
KS-00000XJM
KS-1221
MBFKCGGQTYQTLR-SCYNACPDSA-N
MCGSCOLBFJQGHM-SCZZXKLOSA-N
MFCD00903850
MLS006010117
MolPort-003-844-371
MolPort-006-069-118
MolPort-006-823-009
NCGC00164560-01
NCGC00164560-02
NSC742406
SC-16996
SC-20023
SCHEMBL38632
SCHEMBL40817
SCHEMBL40818
SMR004701251
ST24045890
UNII-1PPL256S5A component WMHSRBZIJNQHKT-FFKFEZPRSA-N
UNII-J220T4J9Q2
UNII-WR2TIP26VS
V2105
W-5205
WMHSRBZIJNQHKT-FFKFEZPRSA-N
WR2TIP26VS
Z2471178866
Ziagen
Ziagen (TM)(*Succinate salt*)
Ziagen (TN)
ZINC2015928
Paragraph IV (Patent) Challenges for ABACAVIR SULFATE
Tradename Dosage Ingredient NDA Submissiondate
ZIAGEN SOLUTION;ORAL abacavir sulfate 020978 2012-12-27
ZIAGEN TABLET;ORAL abacavir sulfate 020977 2009-01-28

US Patents and Regulatory Information for ABACAVIR SULFATE

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 ABACAVIR SULFATE abacavir sulfate SOLUTION;ORAL 077950-001 Mar 14, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091294-001 Jun 18, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 077844-001 Dec 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 204990-001 Mar 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091050-001 Oct 28, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 208990-001 Nov 15, 2018 DISCN 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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