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Serving leading biopharmaceutical companies globally:

Novartis
Teva
Merck
Express Scripts
Baxter
Mallinckrodt
Citi
US Army
Argus Health
Cantor Fitzgerald

Generated: December 11, 2017

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Adefovir dipivoxil - Generic Drug Details

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What are the generic sources for adefovir dipivoxil and what is the scope of adefovir dipivoxil patent protection?

Adefovir dipivoxil
is the generic ingredient in two branded drugs marketed by Sigmapharm Labs Llc and Gilead, 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.

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

There are eight drug master file entries for adefovir dipivoxil. Three suppliers are listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sigmapharm Labs LlcADEFOVIR DIPIVOXILadefovir dipivoxilTABLET;ORAL202051-001Aug 29, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
GileadHEPSERAadefovir dipivoxilTABLET;ORAL021449-001Sep 20, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeYY► 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
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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International Patent Family for Ingredient: adefovir dipivoxil

Country Document Number Estimated Expiration
China1763057► Subscribe
European Patent Office0996430► Subscribe
Slovenia1256584► Subscribe
Germany69826735► Subscribe
Indonesia28006► Subscribe
Taiwan584635► Subscribe
China1347695► Subscribe
Germany69809749► Subscribe
Argentina016548► Subscribe
Israel133461► 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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Serving leading biopharmaceutical companies globally:

Accenture
US Department of Justice
Fuji
QuintilesIMS
Argus Health
Express Scripts
Chubb
US Army
Mallinckrodt
Merck

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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