COMBIVIR Drug Patent Profile

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When do Combivir patents expire, and what generic alternatives are available?

Combivir is a drug marketed by Viiv Hlthcare and is included in one NDA.

The generic ingredient in COMBIVIR is lamivudine; zidovudine. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Combivir

A generic version of COMBIVIR was approved as lamivudine; zidovudine by LUPIN LTD on May 15^th, 2012.

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Summary for COMBIVIR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	63
Patent Applications:	1,563
Drug Prices:	Drug price information for COMBIVIR
What excipients (inactive ingredients) are in COMBIVIR?	COMBIVIR excipients list
DailyMed Link:	COMBIVIR at DailyMed

Drug patent expirations by year for COMBIVIR

Recent Clinical Trials for COMBIVIR

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

Sponsor	Phase
Augusta University	Phase 4
Massachusetts General Hospital	Phase 2
AIDS Clinical Trials Group	Phase 3

See all COMBIVIR clinical trials

Pharmacology for COMBIVIR

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

US Patents and Regulatory Information for COMBIVIR

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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	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997		DISCN	Yes	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 COMBIVIR

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for COMBIVIR

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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

International Patents for COMBIVIR

See the table below for patents covering COMBIVIR around the world.

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Country	Patent Number	Title	Estimated Expiration
Yugoslavia	19999		⤷ Sign Up
Poland	190349		⤷ Sign Up
Germany	69232387		⤷ Sign Up
United Kingdom	8523878		⤷ Sign Up
Czech Republic	282720	2-substituované-5-substituované-1,3-oxathiolanové deriváty (2-SUBSTITUTED, 5-SUBSTITUTED 1,3-OXATHIOLATE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for COMBIVIR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3494972	LUC00346	Luxembourg	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
3494972	301277	Netherlands	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
0382526	SPC/GB96/043	United Kingdom	⤷ Sign Up	PRODUCT NAME: LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH 53662 19960228; CH 53663 19960228; UK EU/1/96/015/001 19960808; UK EU/1/96/015/002 19960808
0382526	19675032	Germany	⤷ Sign Up	PRODUCT NAME: LAMIVUDINE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH GEEIGNETEN SALZES; NAT. REGISTRATION NO/DATE: EU/1/96/015/001-002 19960808 FIRST REGISTRATION: CH 53662 53663 19960228
0513917	98C0020	Belgium	⤷ Sign Up	PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for COMBIVIR

Recent Clinical Trials for COMBIVIR

Pharmacology for COMBIVIR

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