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:	5,746
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
European Patent Office	0481754	Hydroxymethyl(methylènecyclopentyl)Purines et Pyrimidines (Hydroxymethyl(methylenecyclopentyl)Purines and Pyrimidines)
Denmark	0481754
Brazil	1100846
Greece	3025395
Poland	292101

Supplementary Protection Certificates for BARACLUDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C00481754/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
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
0481754	91275	Luxembourg		CERTIFICATE TITLE: ENTECAVIR ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BARACLUDE); FIRST REGISTRATION: 20060626

BARACLUDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BARACLUDE

Overview of BARACLUDE

BARACLUDE, also known as entecavir, is a nucleoside analog used in the treatment of chronic hepatitis B virus (HBV) infection. It is endorsed by physicians for its strong antiviral effects, quicker onset of action, fewer side effects, and lower resistance rates compared to other antiviral medications[4].

Market Size and Growth

The hepatitis B market, which includes BARACLUDE, has been experiencing steady growth. As of 2023, the hepatitis B market size was valued at USD 3.3 billion and is projected to reach USD 4.9 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 3.83% during the forecast period of 2024-2034[1].

Key Drivers of Market Growth

Several factors are driving the growth of the hepatitis B market, including:

Advancements in Antiviral Therapies

The introduction of new antiviral drugs with higher precision and fewer side effects is a significant driver. BARACLUDE, in particular, has been a focus of research initiatives by Bristol-Myers Squibb, exploring combination therapies to enhance treatment outcomes and reduce drug resistance[1].

Increasing Prevalence and Awareness

The rising prevalence of HBV infections and growing awareness of the disease's impact on public health are driving market growth. In the United States, for example, approximately 862,000 people are living with chronic HBV infection, necessitating robust diagnosis, management, and treatment strategies[1].

Government Initiatives and Healthcare Policies

Government initiatives and healthcare policies promoting routine HBV screening and immunization, especially among high-risk populations, are further propelling the market. These efforts have led to increased early diagnosis and vaccination programs[1].

Regional Analysis

The major markets for hepatitis B treatment, including BARACLUDE, are the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. The United States has the largest patient pool for hepatitis B and represents the biggest market for its treatment due to the increasing prevalence of HBV infections and heightened awareness[1].

Financial Performance of BARACLUDE

Revenue Trends

In Q1 2021, Bristol-Myers Squibb generated $113.01 million from the BARACLUDE brand, which is a decrease of 7% from $122.01 million in Q1 2020. Despite this decline, BARACLUDE remains a significant player in the hepatitis B treatment market, particularly in countries like the US, the UK, Japan, China, France, Germany, Italy, and Spain[5].

Market Share

BARACLUDE accounts for a smaller but still notable share of Bristol-Myers Squibb's revenue. In Q1 2021, it represented about 1% of the company's total revenue, highlighting its niche but important position in the antiviral drug market[5].

Competitive Landscape

The hepatitis B treatment market is competitive, with new medications entering the market and shaping the competitive scenario. BARACLUDE faces competition from other antiviral drugs, but its strong antiviral effects and lower resistance rates continue to make it a preferred choice for many patients and healthcare providers[4].

Future Outlook

Combination Therapies

Research into combination therapies involving BARACLUDE with other antiviral agents or immune modulators is expected to enhance treatment outcomes and reduce drug resistance. This approach aims to achieve higher rates of sustained virological response (SVR) and is likely to sustain the market growth of BARACLUDE[1].

Global Health Initiatives

Global health initiatives, such as those by the World Health Organization (WHO), focusing on a "Hepatitis-Free Future" and aiming to prevent mother-to-child transmission of HBV, will continue to drive demand for effective antiviral medications like BARACLUDE[4].

Challenges and Opportunities

Drug Resistance

One of the significant challenges in the long-term treatment of HBV is drug resistance. The development of combination therapies and the continuous monitoring of treatment efficacy are crucial in addressing this issue[1].

Emerging Markets

The rise in economic development in emerging markets and the increasing awareness of the benefits of antiviral medications present opportunities for growth. Large-scale approvals in developed countries and an increase in antiviral prescriptions are expected to contribute to the beneficial development of the BARACLUDE market[4].

Key Takeaways

• The hepatitis B market, including BARACLUDE, is expected to grow from USD 3.3 billion in 2023 to USD 4.9 billion by 2034.
• Advancements in antiviral therapies and combination treatments are key drivers of market growth.
• Government initiatives and healthcare policies are crucial in promoting early diagnosis and treatment.
• BARACLUDE faces competition but remains a preferred choice due to its strong antiviral effects and lower resistance rates.
• Future research into combination therapies and global health initiatives will continue to drive the market.

FAQs

What is BARACLUDE used for?

BARACLUDE, or entecavir, is used in the treatment of chronic hepatitis B virus (HBV) infection in adults where the virus is replicating.

What are the key drivers of the hepatitis B market growth?

The key drivers include the introduction of new antiviral drugs, increasing prevalence and awareness of HBV infections, and government initiatives promoting early diagnosis and treatment.

How is the financial performance of BARACLUDE?

In Q1 2021, BARACLUDE generated $113.01 million in revenue, a 7% decrease from Q1 2020, but it remains a significant player in the hepatitis B treatment market.

What are the future outlook and challenges for BARACLUDE?

The future outlook includes the development of combination therapies to enhance treatment outcomes and reduce drug resistance. A significant challenge is addressing drug resistance through continuous monitoring and innovative treatment strategies.

Which regions are the major markets for hepatitis B treatment?

The major markets include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan, with the United States having the largest patient pool and market for HBV treatment.

Sources

1. IMARC Group, "Hepatitis B Market Estimated to Reach USD 4.9 Billion by 2034..."
2. Bristol Myers Squibb, "Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2022"
3. CDC Science Clips, "Nasrullah M - CDC Science Clips"
4. GlobeNewswire, "Entecavir Market Sales are Supported by Approvals gained by Pharmaceutical Companies for Producing Entecavir"
5. BusinessQuant, "Bristol-Myers Squibb's Revenue Breakdown (2016-2023)"