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Last Updated: August 7, 2020

DrugPatentWatch Database Preview

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, Prinston Inc, Sunshine Lake, Teva Pharms Usa, Yaopharma Co Ltd, and Zydus Pharms, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for entecavir. Seventeen suppliers are listed for this compound.

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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SponsorPhase
Synteract, Inc.Phase 2
Novotech (Australia) Pty LimitedPhase 2
ParexelPhase 2

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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
Cipla ENTECAVIR entecavir TABLET;ORAL 206872-001 Dec 6, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ENTECAVIR entecavir TABLET;ORAL 206745-002 Jun 23, 2017 AB RX 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
Mylan ENTECAVIR entecavir TABLET;ORAL 206226-001 Mar 26, 2019 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
Accord Hlthcare ENTECAVIR entecavir TABLET;ORAL 205824-002 Aug 25, 2017 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 SOLUTION;ORAL 021798-001 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-001 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-002 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005   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:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.