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Generated: May 26, 2017

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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 entecavir freedom to operate?

is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Teva Pharms Usa, Hetero Labs Ltd V, Amneal Pharms, Cipla Ltd, Par Pharm Inc, and Bristol Myers Squibb, and is included in eight NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for entecavir. Eleven suppliers are listed for this compound.

Summary for Generic Name: entecavir

Drug Master File Entries: see list15
Suppliers / Packagers: see list11
Bulk Api Vendors: see list64
Clinical Trials: see list69
Patent Applications: see list2,780
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:entecavir at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
SOLUTION;ORAL021798-001Mar 29, 2005RXYesYes► Subscribe► Subscribe
Teva Pharms Usa
TABLET;ORAL202122-002Aug 26, 2014ABRXNoNo► Subscribe► Subscribe
Bristol Myers Squibb
SOLUTION;ORAL021798-001Mar 29, 2005RXYesYes► Subscribe► Subscribe
Bristol Myers Squibb
TABLET;ORAL021797-002Mar 29, 2005ABRXYesYes► Subscribe► Subscribe
Par Pharm Inc
TABLET;ORAL206294-001Nov 23, 2016ABRXNoNo► Subscribe► Subscribe
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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 verifification 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.

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