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Adefovir dipivoxil - Generic Drug Details

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Adefovir dipivoxil is the generic ingredient in two branded drugs marketed by Gilead and Sigmapharm Labs Llc, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-six patent family members in twenty-five countries.

There are eight drug master file entries for adefovir dipivoxil. Three suppliers are listed for this compound.

Summary for Generic Name: adefovir dipivoxil

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list8
Suppliers / Packaging: see list3
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: adefovir dipivoxil

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 2002RXYes6,451,340► subscribeYY ► subscribe
Sigmapharm Labs Llc
ADEFOVIR DIPIVOXIL
adefovir dipivoxil
TABLET;ORAL202051-001Aug 29, 2013RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: adefovir dipivoxil

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, 20025,663,159► subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 20024,808,716► subscribe
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International Patent Family for Ingredient: adefovir dipivoxil

Country Document Number Estimated Expiration
China1763057► subscribe
European Patent Office0996430► subscribe
Slovenia1256585► 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: ADEFOVIR DIPIVOXIL

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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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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