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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Chubb
Julphar
Citi
Boehringer Ingelheim
Covington
Cantor Fitzgerald
Colorcon
Fish and Richardson
UBS

Generated: October 17, 2017

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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 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.

Summary for Tradename: HEPSERA

US 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 (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
South Korea20060038363► Subscribe
Austria277936► Subscribe
Portugal1256584► Subscribe
Spain2229030► Subscribe
Spain2187991► Subscribe
Turkey200200117► Subscribe
Turkey200200137► Subscribe
India190037► Subscribe
Austria228357► Subscribe
New Zealand501659► 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
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
C/GB03/030United Kingdom► SubscribePRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK 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 leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Johnson and Johnson
Accenture
Julphar
Harvard Business School
Federal Trade Commission
Novartis
Chinese Patent Office
Mallinckrodt

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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