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Serving leading biopharmaceutical companies globally:

Chubb
Harvard Business School
Healthtrust
Johnson and Johnson
Federal Trade Commission
Deloitte
AstraZeneca
Citi
Cantor Fitzgerald
Moodys

Generated: January 21, 2018

DrugPatentWatch Database Preview

Epivir Drug Profile

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When do Epivir patents expire, and when can generic versions of Epivir launch?

Epivir is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has ninety-seven patent family members in forty-eight countries.

The generic ingredient in EPIVIR is lamivudine. There are twenty-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the lamivudine profile page.

US Patents and Regulatory Information for Epivir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 AA RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 AA RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 AA RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Epivir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 ➤ Subscribe ➤ Subscribe
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for EPIVIR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 100 mg ➤ Subscribe 10/31/2007
➤ Subscribe Tablets 150 mg and 300 mg ➤ Subscribe 10/16/2007
➤ Subscribe Oral Solution 10 mg/mL ➤ Subscribe 11/22/2011

International Patents for Epivir

Supplementary Protection Certificates for Epivir

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB96/043 United Kingdom ➤ Subscribe 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
C0020 Belgium ➤ Subscribe PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
80018 Netherlands ➤ Subscribe PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
C/GB98/019 United Kingdom ➤ Subscribe PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318
C0022 France ➤ Subscribe PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Cipla
Mallinckrodt
Farmers Insurance
Moodys
Queensland Health
QuintilesIMS
Cantor Fitzgerald
Federal Trade Commission

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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