ABACAVIR SULFATE Drug Patent Profile

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Abacavir Sulfate is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Mylan Labs Ltd, Aurobindo Pharma, Chartwell Rx, Laurus, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd. and is included in seventeen NDAs.

The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

US Patents:	0
Applicants:	13
NDAs:	17
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	65
Patent Applications:	3,433
Formulation / Manufacturing:	see details
DailyMed Link:	ABACAVIR SULFATE at DailyMed

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

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

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

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	ABACAVIR SULFATE	abacavir sulfate	SOLUTION;ORAL	077950-001	Mar 14, 2018	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Pharms Inc	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	091294-001	Jun 18, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	077844-001	Dec 17, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Rx	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	204990-001	Mar 28, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Strides Pharma	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	091050-001	Oct 28, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	208990-001	Nov 15, 2018		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration