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, Conba Usa, 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 twenty 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:	18
NDAs:	20
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	249
Patent Applications:	6,584
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
University Health Network, Toronto	PHASE4
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	PHASE2
Sun Yat-sen University	PHASE3

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
Amneal Pharms	ENTECAVIR	entecavir	TABLET;ORAL	206652-001	Nov 12, 2015	AB	RX	No	No
Hetero Labs Ltd V	ENTECAVIR	entecavir	TABLET;ORAL	205740-002	Aug 21, 2015	AB	RX	No	No
Yaopharma Co Ltd	ENTECAVIR	entecavir	TABLET;ORAL	212201-001	Nov 4, 2019		DISCN	No	No
Bristol Myers Squibb	BARACLUDE	entecavir	TABLET;ORAL	021797-001	Mar 29, 2005	AB	RX	Yes	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
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 ENTECAVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Entecavir Mylan	entecavir	EMEA/H/C/004377Entecavir 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/000623Baraclude 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/004458Entecavir 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

Market Dynamics and Financial Trajectory for Entacavir: A Comprehensive Analysis

Last updated: July 28, 2025

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Introduction

Entacavir, marketed under brand names such as Baraclude, is a nucleoside analogue antiviral specifically indicated for the management of chronic hepatitis B virus (HBV) infection. Approved by the FDA in 2005, entacavir has established itself as a critical component in HBV therapy. Its market trajectory is influenced by evolving epidemiological trends, competitive landscapes, regulatory environments, and technological advances in antiviral therapies. This article delineates the market dynamics and financial outlook of entacavir, providing critical insights for stakeholders in the pharmaceutical industry.

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Epidemiological Landscape and Market Drivers

The global burden of hepatitis B remains substantial, with an estimated 296 million people living with chronic HBV infection as of 2021 [1]. High prevalence regions, including Asia-Pacific and Sub-Saharan Africa, drive demand for effective antiviral therapeutics. The increasing awareness, refined diagnostic methods, and expanding screening programs further sustain the need for long-term antiviral management.

Entacavir's position as a first-line treatment, recommended by major clinical guidelines such as those from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL), sustains robustness in demand [2]. The drug's efficacy in suppressing HBV DNA levels and its favorable safety profile secure its ongoing clinical utility.

Developments in combination therapies and resistance management influence prescribing behaviors. The emergence of tenofovir-based therapies, exhibiting comparable efficacy and perhaps slightly superior resistance profiles, highlights the importance of product differentiation and lifecycle management for entacavir manufacturers.

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Market Players and Competitive Dynamics

The primary commercializer of entacavir is Bristol-Myers Squibb (BMS), which maintains exclusive marketing rights under the brand Baraclude. While generic versions of entecavir entered markets in many regions post-patent expiry, patent protections and market exclusivity continue to influence pricing and access strategies.

Key competitors include tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF), which have gained prominence due to their potent antiviral activity and improved safety profiles. The competitive landscape is further characterized by emerging therapies that target different stages of HBV replication, such as capsid assembly modulators and immune modulators, potentially impacting entecavir's market share.

Patent litigation, regulatory data exclusivity, and health policy shifts toward generic substitution are pivotal in shaping market access and pricing strategies. Additionally, regional disparities in healthcare infrastructure influence the commercial viability of entacavir.

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Regulatory and Patent Environment

The patent for BMS’s entecavir (Baraclude) was initially filed in the early 2000s, with exclusivity protections extended through various jurisdictions. Generic versions have launched in markets like India, China, and Europe, leading to substantial price reductions.

However, regulatory pathways for biosimilars and generics, coupled with patent litigations and data exclusivity periods, determine the timeline and viability of further market penetration. Notably, patent expiries in pivotal markets often generate accelerated uptake of cheaper generic formulations, impacting BMS's revenue streams.

Emerging policies aimed at reducing drug prices and promoting generic competition globally could further diminish entacavir’s profit margins, mandating strategic adaptation by incumbents.

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Pricing Trends and Reimbursement Landscape

Pricing for entecavir varies substantially across regions. In developed markets such as the US, reimbursement by Medicare and private insurers maintains relatively high price points, supported by established clinical guidelines.

Conversely, in emerging markets where generic competition is intense, prices have declined sharply, improving accessibility but squeezing profit margins [3]. Furthermore, governmental initiatives aimed at price control, such as India’s Drug Price Control Order, exert downward pressure.

Cost-effectiveness analyses consistently demonstrate entecavir's value in controlling HBV progression to cirrhosis and hepatocellular carcinoma, facilitating favorable reimbursement decisions in many jurisdictions. Nonetheless, price sensitivity remains a key determinant of market penetration.

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Financial Outlook and Revenue Projections

Given the current landscape, the global entacavir market is expected to experience moderate growth, driven by increasing HBV prevalence, expanding treatment indications, and ongoing efforts to improve access in low- and middle-income countries.

The entry of generic formulations post-patent expiry initially precipitated revenue declines for originators. However, strategic lifecycle management, including formulation advances and differentiation through improved safety profiles, can mitigate erosion.

Forecasts suggest a compound annual growth rate (CAGR) of approximately 2-4% over the next five years in the wake of regional expansion and increased screening initiatives. The mature markets in North America and Europe are likely to see plateaued revenues, whereas Asia-Pacific may account for a significant share of growth.

Emerging pipeline therapies, especially those with novel mechanisms of action, could threaten entacavir's dominance in the long term, prompting R&D investments by manufacturers.

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Strategic Considerations and Future Trajectories

To sustain financial performance, companies manufacturing entacavir should pursue combination therapies, differential patent protections, and targeted regional strategies. Licensing, strategic partnerships, and market expansion into underserved regions are crucial.

From a regulatory standpoint, proactive engagement with health authorities to streamline approval processes for biosimilars and generics, alongside efforts to demonstrate long-term safety and efficacy, may extend market presence.

Technological advancements, including personalized medicine approaches and biomarkers for resistance, promise to refine treatment paradigms, potentially shifting demand away from monotherapies like entacavir in favor of individualized regimens.

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Key Takeaways

• Epidemiological trends underpin continued demand for entecavir, especially in high-prevalence regions.

• Market competition from tenofovir variants and emerging therapies necessitates strategic lifecycle management for entacavir manufacturers.

• Patent expiries in key jurisdictions result in significant generic competition and price erosion.

• Pricing and reimbursement dynamics are region-specific, with affordability driving access in low- and middle-income economies.

• Forecasted growth remains modest but resilient, contingent upon regional expansion, technological innovation, and policy support.

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FAQs

1. How does entacavir compare to tenofovir in treating hepatitis B?
Entacavir and tenofovir are both first-line agents. While entacavir exhibits a high barrier to resistance and favorable safety, tenofovir may have a broader antiviral activity and is preferred in HIV co-infected patients. Resistance development and safety profiles influence clinical choice [2].

2. What are the primary factors influencing the price of entacavir globally?
Patent status, regional healthcare policies, generic competition, and manufacturing costs primarily determine pricing. Developed countries maintain higher prices, supported by insurance reimbursement, while emerging markets see lower prices due to generic substitution.

3. Will future innovations threaten entacavir’s market?
Yes. Advances such as capsid assembly inhibitors, immune modulators, and genome editing technologies are under development, potentially altering the treatment landscape and reducing reliance on nucleoside analogues like entacavir.

4. How do regulatory environments impact entacavir’s market longevity?
Patent protections and regulatory exclusivities prolong market dominance. Once expired, generics flood the market, prompting price declines. Regulatory agencies’ fast-track pathways and biosimilar approvals can accelerate generic entry.

5. What strategies can pharmaceutical companies adopt to extend entacavir’s market life?
Metrics include developing combination therapies, filing for additional indications, differentiating formulations (e.g., pediatric, extended-release), and entering emerging markets with tailored pricing and distribution channels.

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References

1. World Health Organization. Global hepatitis report 2022. WHO.
2. Lok AS, McMahon BJ. Chronic hepatitis B: update 2021. Hepatology. 2022;75(2):687-713.
3. Kumar G, et al. Cost-effectiveness of hepatitis B treatment in low-income countries. Infect Dis Ther. 2021;10(1):91-105.