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Last Updated: April 18, 2021

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ENTECAVIR Drug Profile

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Which patents cover Entecavir, and what generic alternatives are available?

Entecavir is a drug marketed by 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 sixteen NDAs.

The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the entecavir profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Entecavir

A generic version of ENTECAVIR was approved as entecavir by HETERO LABS LTD V on August 21st, 2015.

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Drug patent expirations by year 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

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Ascentage Pharma Group Inc.Phase 2
Sunshine Lake Pharma Co., Ltd.Phase 1/Phase 2
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationPhase 4

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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
Zydus Pharms ENTECAVIR entecavir TABLET;ORAL 206745-002 Jun 23, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ENTECAVIR entecavir TABLET;ORAL 202122-002 Aug 26, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Yaopharma Co Ltd ENTECAVIR entecavir TABLET;ORAL 212201-001 Nov 4, 2019 DISCN 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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