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Last Updated: December 6, 2019

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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 freedom to operate?

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, Teva Pharms Usa, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for entecavir. Eighteen 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
Henlix, IncPhase 2
West China HospitalPhase 4
First Hospital of Jilin UniversityPhase 4

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Recent Litigation for entecavir

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District Court Litigation
Case NameDate
Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA, Inc2013-04-04
Bristol-Myers Squibb Company v. Sandoz Inc.2012-06-21
Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA Inc.2010-09-22

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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
Hetero Labs Ltd V ENTECAVIR entecavir TABLET;ORAL 205740-002 Aug 21, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla ENTECAVIR entecavir TABLET;ORAL 206872-002 Dec 6, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ENTECAVIR entecavir TABLET;ORAL 206226-002 Mar 26, 2019 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 021797-002 Mar 29, 2005   Start Trial   Start Trial
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-001 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:

Boehringer Ingelheim
Moodys
McKesson
Johnson and Johnson
AstraZeneca
Medtronic

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