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Serving leading biopharmaceutical companies globally:

US Army
Novartis
US Department of Justice
Dow
Johnson and Johnson
UBS
Argus Health
Express Scripts
Colorcon
Daiichi Sankyo

Generated: December 13, 2017

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HEPSERA Drug Profile

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

Hepsera is a drug marketed by Gilead and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in twenty-five countries and three supplementary protection certificates in three countries.

The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
GileadHEPSERAadefovir dipivoxilTABLET;ORAL021449-001Sep 20, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Patents for Tradename: HEPSERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GileadHEPSERAadefovir dipivoxilTABLET;ORAL021449-001Sep 20, 2002► Subscribe► Subscribe
GileadHEPSERAadefovir dipivoxilTABLET;ORAL021449-001Sep 20, 2002► Subscribe► Subscribe
GileadHEPSERAadefovir dipivoxilTABLET;ORAL021449-001Sep 20, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for HEPSERA

Drugname Dosage Strength RLD Submissiondate
adefovir dipivoxilTablets10 mgHepsera6/8/2010

International Patent Family for Tradename: HEPSERA

Country Document Number Estimated Expiration
Japan2001512712► Subscribe
Slovenia1256584► Subscribe
Spain2229029► Subscribe
Hong Kong1091211► Subscribe
Hong Kong1051693► Subscribe
Germany69826734► Subscribe
South Korea100700089► Subscribe
Brazil9811552► Subscribe
Denmark1256584► Subscribe
Spain2187991► 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: HEPSERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00131Netherlands► SubscribePRODUCT NAME: ADEFOVIR DIPIVOXIL, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE ZUURADDITIE ZOUTEN, METAALZOUTEN EN SOLVATEN HIERVAN; NAT. REGISTRATION NO/DATE: EU/1/03/251/001 20030306; FIRST REGISTRATION: EU/1/03/251/001 20030306
C0034France► SubscribePRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
C/GB03/030United Kingdom► SubscribePRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306
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Serving leading biopharmaceutical companies globally:

Fuji
Express Scripts
Accenture
Boehringer Ingelheim
McKesson
Teva
Merck
Argus Health
Daiichi Sankyo
US Department of Justice

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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