Abacavir sulfate - Generic Drug Details

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

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

Summary for abacavir sulfate

US Patents:	2
Tradenames:	8
Applicants:	12
NDAs:	22
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	65
Patent Applications:	6,329
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in abacavir sulfate?	abacavir sulfate excipients list
DailyMed Link:	abacavir sulfate at DailyMed

Recent Clinical Trials for abacavir sulfate

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

Sponsor	Phase
Cynthia L Gay, MD	N/A
ViiV Healthcare	N/A
University of North Carolina, Chapel Hill	N/A

See all abacavir sulfate clinical trials

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 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for abacavir sulfate

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ABACAVIR SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIAGEN	Oral Solution	abacavir sulfate	20 mg/mL	020978	1	2012-12-27
ZIAGEN	Tablets	abacavir sulfate	300 mg	020977	1	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	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes			Y	Y
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	AB	RX	Yes	Yes
Cipla	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	078119-001	Nov 21, 2017	AB	RX	No	No
Hetero Labs Ltd Iii	ABACAVIR SULFATE	abacavir sulfate	SOLUTION;ORAL	201107-001	Sep 26, 2016	AA	RX	No	No
Aurobindo Pharma	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	206151-001	Mar 28, 2017		DISCN	No	No
Apotex Inc	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	201570-001	Dec 17, 2012		DISCN	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
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998