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HEPSERA Drug Profile

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Which patents cover Hepsera, and what substitute generic drugs 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 list11
Patent Applications: see list4,033
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:HEPSERA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 2002RXYesYes6,451,340► 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, 20024,724,233► Subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 20024,808,716► Subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 20025,663,159► 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
Japan4452034► Subscribe
China1347695► Subscribe
Austria228357► Subscribe
South Korea20060038363► Subscribe
China1763056► 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
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
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