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Lamivudine; zidovudine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for lamivudine; zidovudine?

Lamivudine; zidovudine is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Strides Pharma, Lupin Ltd, Viiv Hlthcare, Hetero Labs Ltd V, and Teva Pharms, and is included in eight NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty patent family members in twenty-eight countries.

There are twenty-six drug master file entries for lamivudine; zidovudine. Twenty-three suppliers are listed for this compound. There are nineteen tentative approvals for this compound.

Summary for Generic Name: lamivudine; zidovudine

Tradenames:2
Patents:2
Applicants:8
NDAs:8
Drug Master File Entries: see list26
Suppliers / Packagers: see list23
Clinical Trials: see list161
Therapeutic Class:Antivirals
Drug Prices:see low prices
DailyMed Link:lamivudine; zidovudine at DailyMed

Tentative approvals for LAMIVUDINE; ZIDOVUDINE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL150MG; 300MG; 200MG
► Subscribe► SubscribeTABLET; ORAL150MG; 300MG; 200MG
► Subscribe► SubscribeTABLET; ORAL150MG; 300MG; 600MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma
LAMIVUDINE AND ZIDOVUDINE
lamivudine; zidovudine
TABLET;ORAL079128-001May 13, 2015RXNoNo► Subscribe► Subscribe
Hetero Labs Ltd Iii
LAMIVUDINE AND ZIDOVUDINE
lamivudine; zidovudine
TABLET;ORAL079124-001Sep 17, 2015RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
LAMIVUDINE AND ZIDOVUDINE
lamivudine; zidovudine
TABLET;ORAL204005-001Aug 28, 2014RXNoNo► Subscribe► Subscribe
Teva Pharms
LAMIVUDINE AND ZIDOVUDINE
lamivudine; zidovudine
TABLET;ORAL079081-001May 25, 2011RXNoNo► Subscribe► Subscribe
Lupin Ltd
LAMIVUDINE AND ZIDOVUDINE
lamivudine; zidovudine
TABLET;ORAL090246-001May 15, 2012RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lamivudine; zidovudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19975,905,082*PED► Subscribe
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19974,724,232*PED► Subscribe
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19974,837,208*PED► Subscribe
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19975,047,407*PED► Subscribe
Viiv Hlthcare
COMBIVIR
lamivudine; zidovudine
TABLET;ORAL020857-001Sep 26, 19975,859,021*PED► Subscribe
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International Patent Family for Ingredient: lamivudine; zidovudine

Country Document Number Estimated Expiration
European Patent Office0517145► Subscribe
Slovakia125793► Subscribe
African Intellectual Property Organization (OAPI)9913► Subscribe
Australia1736192► Subscribe
Denmark0517145► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LAMIVUDINE; ZIDOVUDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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