ENTECAVIR - Generic Drug Details

What are the generic 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, Breckenridge, Brightgene, Chartwell Rx, Cipla, Hetero Labs Ltd V, Prinston Inc, Rising, Sunshine, Swiss Pharm, Teva Pharms Usa, Yaopharma Co Ltd, Yung Shin Pharm, and Zydus Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for entecavir. Sixteen suppliers are listed for this compound.

Summary for ENTECAVIR

US Patents:	0
Tradenames:	2
Applicants:	17
NDAs:	19
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	243
Patent Applications:	6,071
Drug Prices:	Drug price trends for ENTECAVIR
What excipients (inactive ingredients) are in ENTECAVIR?	ENTECAVIR excipients list
DailyMed Link:	ENTECAVIR at DailyMed

See drug prices for ENTECAVIR

See drug sales revenues for ENTECAVIR

Recent Clinical Trials for ENTECAVIR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shanghai HEP Pharmaceutical Co., Ltd.	Phase 2
E-DA Hospital	N/A
Shanghai Zhimeng Biopharma, Inc.	Phase 2

See all ENTECAVIR clinical trials

Pharmacology for ENTECAVIR

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ENTECAVIR

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ENTECAVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BARACLUDE	Tablets	entecavir	0.5 mg and 1 mg	021797	1	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
Zydus Pharms	ENTECAVIR	entecavir	TABLET;ORAL	206745-002	Jun 23, 2017	AB	RX	No	No
Rising	ENTECAVIR	entecavir	TABLET;ORAL	206226-001	Mar 26, 2019		DISCN	No	No
Brightgene	ENTECAVIR	entecavir	TABLET;ORAL	212126-002	Sep 25, 2019	AB	RX	No	No
Chartwell Rx	ENTECAVIR	entecavir	TABLET;ORAL	206294-001	Nov 23, 2016		DISCN	No	No
Amneal Pharms	ENTECAVIR	entecavir	TABLET;ORAL	206652-002	Nov 12, 2015	AB	RX	No	No
Zydus Pharms	ENTECAVIR	entecavir	TABLET;ORAL	206745-001	Jun 23, 2017	AB	RX	No	No

Expired US Patents for ENTECAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-002	Mar 29, 2005
Bristol Myers Squibb	BARACLUDE	entecavir	SOLUTION;ORAL	021798-001	Mar 29, 2005
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-001	Mar 29, 2005
Bristol Myers Squibb	BARACLUDE	entecavir	SOLUTION;ORAL	021798-001	Mar 29, 2005

EU/EMA Drug Approvals for ENTECAVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Entecavir Mylan	entecavir	EMEA/H/C/004377 Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to	Authorised	yes	no	no	2017-09-18
Bristol-Myers Squibb Pharma EEIG	Baraclude	entecavir	EMEA/H/C/000623 Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis;decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.	Authorised	no	no	no	2006-06-26
Accord Healthcare S.L.U.	Entecavir Accord	entecavir	EMEA/H/C/004458 Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:, , , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease., , , For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B., , Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to	Authorised	yes	no	no	2017-09-25