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Last Updated: June 28, 2022

Adefovir dipivoxil - Generic Drug Details


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What are the generic drug sources for adefovir dipivoxil and what is the scope of freedom to operate?

Adefovir dipivoxil is the generic ingredient in two branded drugs marketed by Apotex, Sigmapharm Labs Llc, and Gilead, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for adefovir dipivoxil

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Recent Clinical Trials for adefovir dipivoxil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lai WeiPhase 2
New Discovery LLCPhase 4
Taipei Veterans General Hospital, TaiwanPhase 4

See all adefovir dipivoxil clinical trials

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
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sigmapharm Labs Llc ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 202051-001 Aug 29, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 205459-001 Jul 6, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for adefovir dipivoxil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 See Plans and Pricing See Plans and Pricing
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 See Plans and Pricing See Plans and Pricing
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 See Plans and Pricing See Plans and Pricing
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 See Plans and Pricing See Plans and Pricing
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.
Authorised no no no 2003-03-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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