BARACLUDE Drug Patent Profile

Which patents cover Baraclude, and when can generic versions of Baraclude launch?

Baraclude is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in BARACLUDE is entecavir. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Baraclude

A generic version of BARACLUDE was approved as entecavir by HETERO LABS LTD V on August 21^st, 2015.

Summary for BARACLUDE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	69
Patent Applications:	5,320
Drug Prices:	Drug price information for BARACLUDE
What excipients (inactive ingredients) are in BARACLUDE?	BARACLUDE excipients list
DailyMed Link:	BARACLUDE at DailyMed

See drug prices for BARACLUDE

Recent Clinical Trials for BARACLUDE

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

Sponsor	Phase
Shanghai Zhimeng Biopharma, Inc.	Phase 2
Tigermed Consulting Co., Ltd	Phase 2
Ascentage Pharma Group Inc.	Phase 2

See all BARACLUDE clinical trials

Pharmacology for BARACLUDE

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

Paragraph IV (Patent) Challenges for BARACLUDE

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 BARACLUDE

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	BARACLUDE	entecavir	SOLUTION;ORAL	021798-001	Mar 29, 2005		RX	Yes	Yes
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-001	Mar 29, 2005	AB	RX	Yes	No
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-002	Mar 29, 2005	AB	RX	Yes	Yes

Expired US Patents for BARACLUDE

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

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

International Patents for BARACLUDE

See the table below for patents covering BARACLUDE around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	122006000069
Portugal	99281	PROCESSO PARA A PREPARACAO DE HIDROXIMETIL (METILENOCICLOPENTIL) PURINAS E DE HIDROXIMETIL (METILENOCICLOPENTIL) PIRIMIDINAS
Poland	292101
European Patent Office	0840599	COMPOSITIONS PHARMACEUTIQUES D'OESTROGENES CONJUGUES ET LEURS PROCEDES D'UTILISATION (PHARMACEUTICAL COMPOSITIONS OF CONJUGATED ESTROGENS AND METHODS FOR THEIR USE)
Cyprus	2063	Hydroxymethyl(methylenecyclopentyl)purines and pyrimidines
Austria	401062

Supplementary Protection Certificates for BARACLUDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0481754	C300241	Netherlands		PRODUCT NAME: ENTECAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT, IN HET BIJZONDER ENTECAVIRMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/06/343/001-EU/1/06/343/005 20060626
0481754	06C0040	France		PRODUCT NAME: ENTECAVIR; REGISTRATION NO/DATE: EU/1/06/343/001 20060626
0481754	91275	Luxembourg		CERTIFICATE TITLE: ENTECAVIR ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BARACLUDE); FIRST REGISTRATION: 20060626
0481754	SPC/GB06/032	United Kingdom		PRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626
0481754	CA 2006 00033	Denmark
0481754	33/2006	Austria		PRODUCT NAME: ENTECAVIR UND DESSEN HYDRATE; REGISTRATION NO/DATE: EU/1/06/343/001- EU/1/06/343/005 20060626