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Last Updated: July 12, 2020

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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
Taipei Veterans General Hospital, TaiwanPhase 4
New Discovery LLCPhase 4
Asian-Pacific Alliance of Liver Disease, BeijingPhase 4

See all adefovir dipivoxil clinical trials

Paragraph IV (Patent) Challenges for ADEFOVIR DIPIVOXIL
Tradename Dosage Ingredient NDA Submissiondate
HEPSERA TABLET;ORAL adefovir dipivoxil 021449 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
Sigmapharm Labs Llc ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 202051-001 Aug 29, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 205459-001 Jul 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Johnson and Johnson
Medtronic
Baxter
Dow

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