ABACAVIR SULFATE - Generic Drug Details

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What are the generic sources for abacavir sulfate and what is the scope of patent protection?

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, Norvium Bioscience, Aurobindo Pharma, Chartwell Rx, Laurus, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd, and is included in twenty-three 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:	14
NDAs:	23
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	65
Patent Applications:	4,461
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
National Cancer Institute (NCI)	N/A
Cynthia L Gay, MD	N/A
ViiV Healthcare	N/A

See all ABACAVIR SULFATE clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	60MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	60MG; 30MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	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	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

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Glossary

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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
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	091050-001	Oct 28, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	078119-001	Nov 21, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	091294-001	Jun 18, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	ABACAVIR SULFATE	abacavir sulfate	SOLUTION;ORAL	201107-001	Sep 26, 2016	AA	RX	No	No	⤷ 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

Expired US Patents for ABACAVIR SULFATE

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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	SOLUTION;ORAL	020978-001	Dec 17, 1998	⤷ Sign Up	⤷ Sign Up
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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