Viewing data from:

BARACLUDE

NDA

ENTECAVIR | N021797 | BRISTOL MYERS SQUIBB

2 strengths0 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Bristol-Myers Squibb Company v. Sandoz Inc. 1:2012cv00787 1 patentANDA 203905entecavir	D. Del.	2012-06-21	Terminated 2013-02-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Durvalumab for Advanced Hepatocellular Carcinoma in Patients With Active Chronic Hepatitis B Virus Infection NCT04294498	Phase 2	Completed	National Taiwan University Hospital	30	2020-11-02 → 2026-06-29

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

Medicare Part D Spending

CMS annual spending data for Baraclude (2023)

Total Spending

$2.8M

Total Claims

1,511

Beneficiaries

250

Avg Cost/Unit

$37.09

Spending Trend

$4.0M(2019)→$3.8M(2020)→$3.5M(2021)→$3.1M(2022)→$2.8M(2023)

YoY Change:-2.8%

5yr CAGR:-1.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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 -23	View Letter (PDF)
Dec 21, 2018	SUPPL -21	View Letter (PDF)
Jun 27, 2018	SUPPL -19	View Letter (PDF)
Mar 21, 2014	SUPPL -18	View Letter (PDF)
Dec 20, 2013	SUPPL -17	View Letter (PDF)
Oct 15, 2012	SUPPL -14	View Letter (PDF)
Oct 15, 2012	SUPPL -13	View Letter (PDF)
Jan 4, 2011	SUPPL -11	View Letter (PDF)
Jul 22, 2009	SUPPL -8	View Letter (PDF)
Feb 27, 2009	SUPPL -9	View Letter (PDF)
Jul 31, 2008	SUPPL -5	View Letter (PDF)
Jun 6, 2008	SUPPL -6	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 (2)

Sort:

#001 — 0.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 29, 2005

No patent or exclusivity listings for this strength.

#002 — 1MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 29, 2005