Entecavir - Generic Drug Details

What are the generic drug sources for entecavir and what is the scope of patent protection?

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
Chartwell Rx	ENTECAVIR	entecavir	TABLET;ORAL	206672-001	May 11, 2017		DISCN	No	No
Chartwell Rx	ENTECAVIR	entecavir	TABLET;ORAL	206294-001	Nov 23, 2016		DISCN	No	No
Accord Hlthcare	ENTECAVIR	entecavir	TABLET;ORAL	205824-001	Aug 25, 2017		DISCN	No	No
Hetero Labs Ltd V	ENTECAVIR	entecavir	TABLET;ORAL	205740-002	Aug 21, 2015	AB	RX	No	No
Brightgene	ENTECAVIR	entecavir	TABLET;ORAL	212126-002	Sep 25, 2019	AB	RX	No	No
Sunshine	ENTECAVIR	entecavir	TABLET;ORAL	211978-001	May 20, 2020		DISCN	No	No

Expired US Patents for entecavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	BARACLUDE	entecavir	SOLUTION;ORAL	021798-001	Mar 29, 2005	5,206,244*PED
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-002	Mar 29, 2005	5,206,244*PED
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-001	Mar 29, 2005	5,206,244*PED
Bristol Myers Squibb	BARACLUDE	entecavir	SOLUTION;ORAL	021798-001	Mar 29, 2005	5,908,638

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

Entecavir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Entecavir

Introduction to Entecavir

Entecavir is a potent antiviral drug primarily used for the treatment of chronic hepatitis B virus (HBV) infections. It is known for its high efficacy and good safety profile, making it a preferred first-line treatment for HBV.

Market Size and Growth

The entecavir market has been experiencing steady growth, driven by several key factors. As of 2023, the market size was valued at USD 750 million and is projected to reach USD 1013.5 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4% from 2024 to 2031[1][4].

Drivers of Market Growth

Increasing Incidence of Hepatitis B

The rising incidence of hepatitis B infections globally is a significant driver of the entecavir market. As more people are diagnosed with HBV, the demand for effective antiviral treatments like entecavir increases[1].

Improvements in Diagnostic Tools

Advancements in diagnostic techniques have improved early detection rates, leading to better treatment outcomes and increased market expansion. Early detection enables timely administration of entecavir, which is crucial for managing HBV effectively[1].

Growing Awareness and Understanding

There is a growing awareness among the global population about the importance of treating HBV promptly. This increased awareness drives the demand for antiviral medications, contributing to the market growth of entecavir[1].

Expansion in Developing Economies

The development of healthcare infrastructure in emerging economies has made entecavir more accessible and affordable. Generic versions of the drug have further facilitated its widespread use, contributing to market expansion[1].

Market Segmentation

The entecavir market is segmented based on application, product, and geography.

Application

Entecavir is available in various forms, including tablets and oral solutions. These different formulations cater to different patient needs and preferences, contributing to the market's diversity[1].

Product

The market is segmented into chronic hepatitis B treatment and HBV management. Entecavir's effectiveness in both areas solidifies its position as a leading treatment option[1].

Geography

The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region presents unique market dynamics and growth opportunities[1][4].

Financial Trajectory

Pricing Dynamics

Despite the generic version of entecavir being available since 2014, the out-of-pocket costs for patients have not decreased as expected. A study found that while the cost for pharmacies plummeted from $30.12 to $1.93 per 0.5 mg tablet, the average wholesale price remained constant, and patients' out-of-pocket spending increased from $41 to $52 for a 30-day supply between 2014 and 2018[2].

Impact on Patients

The disparity between pharmacy costs and patient out-of-pocket expenses has significant implications. High-deductible health plans saw average out-of-pocket expenditures rise from $103 to $133, leading to a higher rate of prescription abandonment, which can be dire for patients with chronic hepatitis B[2].

Market Competition

The entecavir market faces competition from other emerging therapies for chronic hepatitis B. However, entecavir's strong efficacy and safety profile continue to make it a dominant player. The launch of late-stage emerging therapies is expected to impact the market, but entecavir's established position is likely to remain robust[4].

Regulatory and Developmental Activities

Mechanism of Action and Dosage

Entecavir works by inhibiting the replication of HBV DNA, making it an effective treatment option. The drug is administered orally, and its dosage is typically 0.5 mg or 1 mg per day, depending on the patient's condition and previous treatment history[4].

Research and Development

Ongoing research and developmental activities focus on novel approaches to treat HBV. Companies are developing new therapies that could potentially challenge entecavir's market dominance, but for now, entecavir remains a cornerstone in HBV treatment[4].

Regional Market Analysis

The entecavir market varies significantly across different regions.

United States and EU

In the United States and EU4 countries (Germany, France, Italy, and Spain), the market is well-established, with a strong presence of major pharmaceutical companies. These regions are expected to continue driving the market growth due to high healthcare spending and advanced diagnostic capabilities[4].

Asia-Pacific

The Asia-Pacific region, particularly China, is a significant market for entecavir. The growing healthcare infrastructure and increasing awareness about HBV treatment are driving the market expansion in this region[1][4].

Challenges and Opportunities

Access to Affordable Treatment

One of the major challenges is ensuring that patients have access to affordable treatment. The development of generic versions and improvements in healthcare infrastructure in emerging economies are steps in the right direction. However, the issue of inflated list prices and the disparity between pharmacy costs and patient out-of-pocket expenses remains a challenge[2].

Market Inefficiencies

Market inefficiencies, such as the failure to pass on savings from generic competition to consumers, need to be addressed. Advocacy and regulatory efforts can help in optimizing market dynamics to benefit patients more effectively[2].

Future Market Trends

The future of the entecavir market looks promising, with expected growth driven by increasing healthcare spending, advancements in diagnostic tools, and the expanding availability of generic versions. However, the market will need to navigate the challenges posed by emerging therapies and ensure that patients benefit from competitive pricing[1][4].

Key Takeaways

• The entecavir market is projected to grow from USD 750 million in 2023 to USD 1013.5 million by 2031.
• The market is driven by the increasing incidence of hepatitis B, improvements in diagnostic tools, and growing awareness about HBV treatment.
• Generic versions and expanding healthcare infrastructure in emerging economies are key factors in market expansion.
• Pricing dynamics and market inefficiencies remain significant challenges.
• The market faces competition from emerging therapies but remains robust due to entecavir's efficacy and safety profile.

FAQs

Q: What is the current market size of entecavir and its projected growth? A: The entecavir market was valued at USD 750 million in 2023 and is expected to reach USD 1013.5 million by 2031, growing at a CAGR of 4% from 2024 to 2031[1].

Q: What are the main drivers of the entecavir market growth? A: The main drivers include the increasing incidence of hepatitis B, improvements in diagnostic tools, growing awareness about HBV treatment, and the expansion of healthcare infrastructure in emerging economies[1].

Q: Why have out-of-pocket costs for entecavir not decreased despite generic competition? A: Despite a reduction in the cost for pharmacies, the average wholesale price has remained constant, and patients' out-of-pocket spending has increased due to market inefficiencies and inflated list prices[2].

Q: How does the entecavir market vary across different regions? A: The market is well-established in the United States and EU4 countries, while the Asia-Pacific region, particularly China, is a significant and growing market due to improving healthcare infrastructure and increasing awareness about HBV treatment[1][4].

Q: What are the challenges and opportunities in the entecavir market? A: Challenges include ensuring access to affordable treatment and addressing market inefficiencies. Opportunities lie in the growing healthcare spending, advancements in diagnostic tools, and the expanding availability of generic versions[1][2][4].

Sources

1. Market Research Intellect: "Entecavir Market Size, Share and Forecast to 2031"
2. KU Medical Center: "Out-of-pocket cost for generic hepatitis B drug increases for patients"
3. Global Hepatitis Programme: "HCV Market Intelligence Report 2021 and Preliminary HBV Market Insights"
4. Research and Markets: "Entecavir Market Size, Forecast, and Market Insight - 2032"