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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 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.

Summary for abacavir sulfate

International Patents:	49
US Patents:	3
Tradenames:	7
Applicants:	10
NDAs:	20
Drug Master File Entries:	12
Suppliers / Packagers:	12
Bulk Api Vendors:	115
Clinical Trials:	11
Patent Applications:	5,709
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for abacavir sulfate
DailyMed Link:	abacavir sulfate at DailyMed

Recent Clinical Trials for abacavir sulfate

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

Sponsor	Phase
National Cancer Institute (NCI)	N/A
ViiV Healthcare	N/A
Cynthia L Gay, MD	N/A

See all abacavir sulfate clinical trials

Recent Litigation for abacavir sulfate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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
		60MG	TABLET; ORAL
		60MG; 30MG	TABLET; ORAL
		60MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for abacavir sulfate

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

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
Apotex Inc	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	201570-001	Dec 17, 2012	AB	RX	No	No
Hetero Labs Ltd Iii	ABACAVIR SULFATE	abacavir sulfate	SOLUTION;ORAL	201107-001	Sep 26, 2016	AA	RX	No	No
Cipla	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	078119-001	Nov 21, 2017	AB	RX	No	No

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
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998

International Patents for abacavir sulfate

Country	Patent Number	Estimated Expiration
Israel	137403
Poland	194558
Slovakia	284397

Supplementary Protection Certificates for abacavir sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0434450	1999C0033	Belgium		PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
0434450	C990028	Netherlands		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		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