Viewing data from:

ENTECAVIR

ANDA

ENTECAVIR | A202122 | TEVA PHARMACEUTICALS USA

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA Inc. et al 1:2010cv00805 1 patentANDA 202122entecavir	D. Del.	2010-09-22	Terminated 2013-03-05	—

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

Medicare Part D Spending

CMS annual spending data for Entecavir (2023)

Total Spending

$34.6M

Total Claims

119,803

Beneficiaries

23,172

Avg Cost/Unit

$6.08

Spending Trend

$28.0M(2019)→$30.4M(2020)→$35.9M(2021)→$37.2M(2022)→$34.6M(2023)

YoY Change:-14.1%

5yr CAGR:-8.8%

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

1 letter from Drugs@FDA

Date	Submission	Document
Aug 28, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 0.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 26, 2014

No patent or exclusivity listings for this strength.

#002 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 26, 2014