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Last Updated: April 15, 2021

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Entecavir - Generic Drug Details

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What are the generic drug sources for entecavir and what is the scope of patent protection?

Entecavir is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Breckenridge, Brightgene, Casi Pharms Inc, Cipla, Hetero Labs Ltd V, Mylan, Par Pharm Inc, Pharmadax Inc, Prinston Inc, Sunshine, Teva Pharms Usa, Yaopharma Co Ltd, and Zydus Pharms, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for entecavir. Twenty-one suppliers are listed for this compound.

Summary for entecavir
Drug Prices for entecavir

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Drug Sales Revenue Trends for entecavir

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Recent Clinical Trials for entecavir

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

SponsorPhase
Ascentage Pharma Group Inc.Phase 2
Sunshine Lake Pharma Co., Ltd.Phase 1/Phase 2
Taipei City HospitalPhase 4

See all entecavir clinical trials

Paragraph IV (Patent) Challenges for ENTECAVIR
Tradename Dosage Ingredient NDA Submissiondate
BARACLUDE TABLET;ORAL entecavir 021797 2010-06-14

US Patents and Regulatory Information for entecavir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla ENTECAVIR entecavir TABLET;ORAL 206872-001 Dec 6, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc ENTECAVIR entecavir TABLET;ORAL 206294-002 Nov 23, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ENTECAVIR entecavir TABLET;ORAL 206745-001 Jun 23, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Brightgene ENTECAVIR entecavir TABLET;ORAL 212126-001 Sep 25, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Breckenridge ENTECAVIR entecavir TABLET;ORAL 208721-001 Mar 15, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Pharmadax Inc ENTECAVIR entecavir TABLET;ORAL 212106-002 Aug 10, 2020 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

Expired US Patents for entecavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-001 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-002 Mar 29, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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