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Generated: October 23, 2018

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Abacavir sulfate - Generic Drug Details

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What are the generic drug sources for abacavir sulfate and what is the scope of abacavir sulfate 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 Ltd, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, and Teva Pharms Usa, and is included in eighteen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Synonyms for abacavir sulfate
((1S,4R)-4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)cyclopent-2-en-1-yl)methanol hemisulfate
(+/-)-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)-9H-PURIN-9-YL]CYCLOPENT-2-EN-1-YL]METHANOL SULFATE
[(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)
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)
470A785
777A485
A807079
AB01566826_01
AB17664
abacavir
Abacavir (INN)
Abacavir (sulfate)
Abacavir [INN:BAN]
Abacavir [INN]
Abacavir Hemisulfate
Abacavir sulfate (JAN/USAN)
Abacavir sulfate [USAN:USP]
Abacavir sulfate, (+/-)-
Abacavir sulfate, >=98% (HPLC)
Abacavir sulphate
abacavirsulfate
ABC sulfate
AC-1299
AC-6112
AC1L9AXG
AC1L9B2P
ACT03218
AK163479
AKOS015994684
AKOS024464970
AKOS025402202
AM015240
AS-17843
BC214924
BDBM50366816
Bio-0001
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
D0A4IJ
DB01048
DR001043
EN300-258000
Epitope ID:137341
Epzicom
FT-0621705
FT-0631153
FT-0660941
HE058172
HE072840
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
NU000340
NU000712
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
Tentative approvals for ABACAVIR SULFATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up60MGTABLET; ORAL
➤ Sign Up➤ Sign Up60MG; 30MGTABLET; ORAL
➤ Sign Up➤ Sign Up60MGTABLET; ORAL

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 TRIZIVIR abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 021205-001 Nov 14, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cipla Ltd ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 078119-001 Nov 21, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lupin Ltd ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912-001 Dec 5, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hetero Labs Ltd Iii ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091560-001 Sep 13, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 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 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for abacavir sulfate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO) 9939691 ➤ Sign Up
China 1515572 ➤ Sign Up
Japan 2002502808 ➤ Sign Up
Saudi Arabia 1122 ➤ Sign Up
Germany 69821758 ➤ Sign Up
Australia 7765598 ➤ Sign Up
African Intellectual Property Organization (OAPI) 11304 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for abacavir sulfate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817637/01 Switzerland ➤ Sign Up PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
/1999 Austria ➤ Sign Up PRODUCT NAME: ''ABACAVIR'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS, EINSCHLIESSLICH ABACAVIR-SULFAT.; NAT. REGISTRATION NO/DATE: EU/1/99/112/001 EU/1/99/112/002 19990708; FIRST REGISTRATION: LI 55048 001, 55049 002 19990628
/2005 Austria ➤ Sign Up PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217
0028 Netherlands ➤ Sign Up 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
99C0033 Belgium ➤ Sign Up PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
90028 Netherlands ➤ Sign Up 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
00195 Netherlands ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Teva
Cantor Fitzgerald
Queensland Health
Fish and Richardson
US Army
Colorcon
QuintilesIMS
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.