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Serving 500+ biopharmaceutical companies globally:

Julphar
AstraZeneca
Merck
Citi
Queensland Health
Covington
Farmers Insurance
Fish and Richardson
Daiichi Sankyo
Dow

Generated: August 21, 2017

DrugPatentWatch Database Preview

HEPSERA Drug Profile

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What is the patent landscape for Hepsera, and what generic Hepsera 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 fifty-six patent family members in twenty-five 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.

Summary for Tradename: HEPSERA

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list76
Clinical Trials: see list16
Patent Applications: see list4,137
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:HEPSERA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 2002ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Tradename: HEPSERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 2002► Subscribe► Subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 2002► Subscribe► Subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 2002► Subscribe► Subscribe
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Paragraph IV activity for: HEPSERA

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

International Patent Family for Tradename: HEPSERA

Country Document Number Estimated Expiration
Japan2009263389► Subscribe
Indonesia28006► Subscribe
Canada2596497► Subscribe
China1763057► Subscribe
Hong Kong1046357► 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
C/GB03/030United Kingdom► SubscribePRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306
C0034France► SubscribePRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
Julphar
Dow
Covington
Queensland Health
Fuji
McKinsey
US Department of Justice
Johnson and Johnson
QuintilesIMS

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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