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Last Updated: April 4, 2020

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ZIAGEN Drug Profile


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

Ziagen is a drug marketed by Viiv Hlthcare and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has forty-nine patent family members in thirty-eight countries.

The generic ingredient in ZIAGEN is abacavir sulfate. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the abacavir sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Ziagen

A generic version of ZIAGEN was approved as abacavir sulfate by MYLAN PHARMS INC on June 18th, 2012.

  Start Trial

Drug patent expirations by year for ZIAGEN
Drug Prices for ZIAGEN

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Recent Clinical Trials for ZIAGEN

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

SponsorPhase
Cellceutix CorporationPhase 1
ViiV HealthcareN/A
GlaxoSmithKlineN/A

See all ZIAGEN clinical trials

Recent Litigation for ZIAGEN

Identify potential future generic entrants

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

See all ZIAGEN litigation

Synonyms for ZIAGEN
((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
[(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-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
1592U89
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)-
470A785
A807079
AB01566826_01
abacavir
Abacavir (INN)
Abacavir [INN:BAN]
Abacavir sulfate
AC-1299
ACT03218
AK163479
AKOS024464970
BCP07728
BDBM50366816
C-18039
C07624
CC-23613
CHEBI:421707
CHEMBL1380
CS-1354
D07057
DB01048
EN300-258000
Epitope ID:137341
FT-0631153
HY-17423
J-700136
KS-00000XJM
MCGSCOLBFJQGHM-SCZZXKLOSA-N
MFCD00903850
MLS006010117
NCGC00164560-01
NCGC00164560-02
NSC742406
Q304330
s5215
SC-16996
SC-20023
SCHEMBL38632
SMR004701251
ST24045890
UNII-WR2TIP26VS
W-5205
WR2TIP26VS
Ziagen (TM)(*Succinate salt*)
ZINC2015928
Paragraph IV (Patent) Challenges for ZIAGEN
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 ZIAGEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 AB RX Yes Yes   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 ZIAGEN

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 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 TABLET;ORAL 020977-001 Dec 17, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZIAGEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 05C0022 France   Start Trial PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
0817637 23/2005 Austria   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Mallinckrodt
Colorcon
Medtronic
Boehringer Ingelheim

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