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Last Updated: January 21, 2020

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ABACAVIR SULFATE - Generic Drug Details

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What are the generic sources for abacavir sulfate and what is the scope of freedom to operate?

Abacavir sulfate is the generic ingredient in seven branded drugs marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Viiv Hlthcare, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, Teva Pharms Usa, and Zydus Pharms, and is included in twenty NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Abacavir sulfate has forty-nine patent family members in thirty-eight countries.

There are twelve drug master file entries for abacavir sulfate. Twelve suppliers are listed for this compound. There are eleven tentative approvals for this compound.

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

Generic filers with tentative approvals for ABACAVIR SULFATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial60MGTABLET; ORAL
  Start Trial  Start Trial60MG; 30MGTABLET; ORAL
  Start Trial  Start Trial60MGTABLET; 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 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
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   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
Aurobindo Pharma Ltd ABACAVIR SULFATE abacavir sulfate SOLUTION;ORAL 077950-001 Mar 14, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 079246-001 Sep 29, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 206151-001 Mar 28, 2017 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

Expired US Patents for ABACAVIR SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ABACAVIR SULFATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817637 05C0022 France   Start Trial PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
0434450 SPC/GB99/032 United Kingdom   Start Trial PRODUCT NAME: ABACAVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE INCLUDING ABACAVIR SULPHATE; REGISTERED: CH CH 55048 001 19990628; CH CH 55049 002 19990628; UK EU/1/99/112/001 19990708; UK EU/1/99/112/002 19990708
0817637 C00817637/01 Switzerland   Start Trial PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
0434450 1999C0033 Belgium   Start Trial PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
0434450 C990028 Netherlands   Start Trial PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
0817637 C300195 Netherlands   Start Trial PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDB AAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HEMISULFAAT, EN LAMIV UDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT; REGISTRTION NO/DATE: EU/04/298/001-002 20041217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Colorcon
Express Scripts
Boehringer Ingelheim
Merck

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