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Last Updated: March 18, 2024

ADEFOVIR DIPIVOXIL Drug Patent Profile


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When do Adefovir Dipivoxil patents expire, and what generic alternatives are available?

Adefovir Dipivoxil is a drug marketed by Apotex and Sigmapharm Labs Llc and is included in two NDAs.

The generic ingredient in ADEFOVIR DIPIVOXIL is adefovir dipivoxil. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Adefovir Dipivoxil

A generic version of ADEFOVIR DIPIVOXIL was approved as adefovir dipivoxil by SIGMAPHARM LABS LLC on August 29th, 2013.

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Paragraph IV (Patent) Challenges for ADEFOVIR DIPIVOXIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HEPSERA Tablets adefovir dipivoxil 10 mg 021449 1 2010-06-08

US Patents and Regulatory Information for ADEFOVIR DIPIVOXIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 205459-001 Jul 6, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sigmapharm Labs Llc ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 202051-001 Aug 29, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ADEFOVIR DIPIVOXIL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Hepsera adefovir dipivoxil EMEA/H/C/000485
Hepsera is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1);decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.
Withdrawn no no no 2003-03-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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