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BARACLUDE

NDA

ENTECAVIR | N021798 | BRISTOL MYERS SQUIBB

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

175 trials from ClinicalTrials.gov — 2 recruiting, 85 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B NCT03933384	Phase 4	Recruiting	Taichung Veterans General Hospital	140	2019-08-19 → 2030-12-31
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF NCT03920618	N/A	Recruiting	Third Affiliated Hospital, Sun Yat-Sen University	150	2019-02-21 → 2024-12-31
A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine NCT00036608	Phase 3	Completed	Bristol-Myers Squibb	—	2002-01 → 2005-02
Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection NCT02097004	Phase 4	Completed	Seoul National University Hospital	111	2014-04 → 2018-03-13
Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy NCT01928511	Phase 4	Completed	Seng Gee Lim	254	2014-01 → 2018-12
Augmenting Response to Entecavir With Peginterferon a-2a for the Treatment of HBeAg-positive Chronic Hepatitis B NCT00877760	Phase 4	Completed	Foundation for Liver Research	184	2009-08 → 2013-07
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection NCT01079806	Phase 3	Completed	Bristol-Myers Squibb	180	2010-06-30 → 2018-03-31
Suboptimal Responders to Adefovir Switching to Entecavir NCT00718887	Phase 4	Completed	Bristol-Myers Squibb	228	2008-07 → 2011-01
A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects NCT03662568	Phase 1	Completed	Sunshine Lake Pharma Co., Ltd.	56	2018-06-26 → 2019-06-10
Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection NCT00371150	Phase 4	Completed	Bristol-Myers Squibb	131	2006-11 → 2011-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$719.13

Highest Price

$965.55

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00003-1614-12BARACLUDE 0.05MG/ML ORAL SOLN	$965.55	FSS	Bristol-Myers Squibb Company	04/30/2029
00003-1614-12BARACLUDE 0.05MG/ML ORAL SOLN	$719.13	Big4	Bristol-Myers Squibb Company	04/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain14 active DMFs6 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDENTECAVIR MONOHYDRATE USP

DMF 236632010

CHONGQING CARELIFE PHARMACEUTICAL CO LTDENTECAVIR HYDRATE USP, NON-STERILE BULK DRUG SUBSTANCE

DMF 246012011

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDENTECAVIR MONOHYDRATE BULK DRUG SUBSTANCE

DMF 252002011

SCINOPHARM TAIWAN LTDENTECAVIR MONOHYDRATE USP

DMF 255492011

HETERO DRUGS LTDENTECAVIR MONOHYDRATE

DMF 263072012

APITORIA PHARMA PRIVATE LTDENTECAVIR

DMF 274012013

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDENTECAVIR MONOHYDRATE

DMF 276002014

LEK PHARMACEUTICALS DDENTECAVIR MONOHYDRATE

DMF 277192013

ZYDUS LIFESCIENCES LTDENTECAVIR USP

DMF 277672013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDENTECAVIR USP

DMF 278482014

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDENTECAVIR MONOHYDRATE

DMF 319492017

WISDOM PHARMACEUTICAL CO LTDENTECAVIR INTERMEDIATE

DMF 326502018

WISDOM PHARMACEUTICAL CO LTDENTECAVIR

DMF 331042018

FUXIN LONG RUI PHARMACEUTICAL CO LTDENTECAVIR MONOHYDRATE

DMF 334902019

APOTEX PHARMACHEM INDIA PVT LTDInactiveENTECAVIR USP

DMF 243052010

KYONGBO PHARMACEUTICAL CO LTDInactiveENTECAVIR

DMF 270662013

WISDOM PHARMACEUTICAL CO LTDInactiveENTECAVIR

DMF 274442013

WISDOM PHARMACEUTICAL CO LTDInactiveENTECAVIR INTERMEDIATE

DMF 304462016

WISDOM PHARMACEUTICAL CO LTDInactiveENTECAVIR INTERMEDIATE

DMF 312482016

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDInactiveENTECAVIR NON STERILE BULK DRUG SUBSTANCE

DMF 336722019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Nov 12, 2019	SUPPL -24	View Letter (PDF)
Dec 21, 2018	SUPPL -23	View Letter (PDF)
Jun 27, 2018	SUPPL -21	View Letter (PDF)
Mar 21, 2014	SUPPL -19	View Letter (PDF)
Dec 20, 2013	SUPPL -18	View Letter (PDF)
Oct 15, 2012	SUPPL -14	View Letter (PDF)
Oct 15, 2012	SUPPL -16	View Letter (PDF)
Jan 4, 2011	SUPPL -12	View Letter (PDF)
Jul 22, 2009	SUPPL -8	View Letter (PDF)
Feb 27, 2009	SUPPL -10	View Letter (PDF)
Jul 31, 2008	SUPPL -6	View Letter (PDF)
Jun 6, 2008	SUPPL -7	View Letter (PDF)
Jul 27, 2007	SUPPL -3	View Letter (PDF)
Mar 31, 2007	SUPPL -2	View Letter (PDF)
Mar 6, 2007	SUPPL -1	View Letter (PDF)
Mar 31, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05MG/ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Mar 29, 2005

No patent or exclusivity listings for this strength.