Lamivudine; zidovudine - Generic Drug Details

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What are the generic sources for lamivudine; zidovudine and what is the scope of freedom to operate?

Lamivudine; zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Epic Pharma Llc, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Natco, Norvium Bioscience, Pharmacare, and Strides Pharma, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound. There are fourteen tentative approvals for this compound.

Summary for lamivudine; zidovudine

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	188
Patent Applications:	370
DailyMed Link:	lamivudine; zidovudine at DailyMed

Recent Clinical Trials for lamivudine; zidovudine

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

Sponsor	Phase
The Aurum Institute NPC	Phase 1/Phase 2
Johns Hopkins University	Phase 1/Phase 2
Wellcome Trust	Phase 2

See all lamivudine; zidovudine clinical trials

Generic filers with tentative approvals for LAMIVUDINE; ZIDOVUDINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	150MG; 300MG; 200MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	150MG; 300MG; 600MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	150MG; 300MG; 300MG	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 lamivudine; zidovudine

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

Anatomical Therapeutic Chemical (ATC) Classes for lamivudine; zidovudine

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

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

US Patents and Regulatory Information for lamivudine; zidovudine

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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
Macleods Pharms Ltd	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	090679-001	Aug 29, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	090246-001	May 15, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	206375-001	Apr 10, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	203259-001	Feb 3, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	077558-001	May 5, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	202418-001	May 15, 2012		DISCN	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 lamivudine; zidovudine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for lamivudine; zidovudine

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva Pharma B.V.	Lamivudine/Zidovudine Teva	lamivudine, zidovudine	EMEA/H/C/001236 Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.	Withdrawn	yes	no	no	2011-02-28
ViiV Healthcare BV	Combivir	lamivudine, zidovudine	EMEA/H/C/000190 Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.,	Authorised	no	no	no	1998-03-18
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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