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Last Updated: April 10, 2021

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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. Three 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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Drug patent expirations by year for ADEFOVIR DIPIVOXIL

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Recent Clinical Trials for ADEFOVIR DIPIVOXIL

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New Discovery LLCPhase 4
Taipei Veterans General Hospital, TaiwanPhase 4
National Health and Family Planning Commission, P.R.ChinaPhase 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
Apotex ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 205459-001 Jul 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sigmapharm Labs Llc ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 202051-001 Aug 29, 2013 AB RX No No   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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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