ENTECAVIR Drug Patent Profile

Which patents cover Entecavir, and what generic alternatives are available?

Entecavir is a drug marketed by 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 eighteen NDAs.

The generic ingredient in ENTECAVIR 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 Entecavir

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

Summary for ENTECAVIR

US Patents:	0
Applicants:	17
NDAs:	18
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	253
Patent Applications:	5,196
Drug Prices:	Drug price information for ENTECAVIR
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
The First Affiliated Hospital of Henan Polytechnic University	PHASE4
Sanmenxia Central Hospital	PHASE4
Yongcheng People's Hospital	PHASE4

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
Yaopharma Co Ltd	ENTECAVIR	entecavir	TABLET;ORAL	212201-002	Nov 4, 2019		DISCN	No	No
Swiss Pharm	ENTECAVIR	entecavir	TABLET;ORAL	212106-002	Aug 10, 2020		DISCN	No	No
Yung Shin Pharm	ENTECAVIR	entecavir	TABLET;ORAL	208195-001	Nov 10, 2021	AB	RX	No	No
Teva Pharms Usa	ENTECAVIR	entecavir	TABLET;ORAL	202122-001	Aug 26, 2014		DISCN	No	No
Accord Hlthcare	ENTECAVIR	entecavir	TABLET;ORAL	205824-001	Aug 25, 2017		DISCN	No	No
Conba Usa	ENTECAVIR	entecavir	TABLET;ORAL	216857-002	Dec 23, 2024	AB	RX	No	No
Rising	ENTECAVIR	entecavir	TABLET;ORAL	206226-002	Mar 26, 2019		DISCN	No	No

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 Entecavir

Last updated: February 20, 2026

What is the current market size for entecavir?

Entecavir, a nucleoside analog reverse transcriptase inhibitor approved in 2006 for chronic hepatitis B virus (HBV) treatment, has a global market valued at approximately USD 250 million in 2022. The market has shown consistent growth, driven by increasing HBV prevalence and treatment rates.

How is the global demand for entecavir evolving?

The demand for entecavir has expanded at a compound annual growth rate (CAGR) of about 8% from 2016 to 2022. The primary growth factors include:

• Rising HBV infection rates in Asia-Pacific and Africa.
• Preference for entecavir over older therapies like lamivudine due to lower resistance.
• Expanded usage in high-risk populations and earlier treatment initiation.

What are the key regional market trends?

Region	Market Size (2022)	Growth Rate (2016–2022)	Key Drivers
North America	USD 80 million	4%	High HBV screening, advanced healthcare infrastructure
Europe	USD 50 million	5%	HBV prevalence, reimbursement policies
Asia-Pacific	USD 110 million	10%	High HBV endemicity, large population base
Rest of World	USD 10 million	7%	Growing awareness, expanding healthcare access

Asia-Pacific dominates the market due to high disease prevalence and limited prevention programs, yet its growth rate outpaces other regions.

What are the competitive dynamics impacting entecavir?

The market features both branded and generic products. Key players include:

• Bristol-Myers Squibb: Original patent holder until patent expiry in 2016.
• Generic manufacturers: Entered rapidly post-patent expiration, controlling over 70% of the market by 2022.

Patent expiries across major markets resulted in price erosion. The average wholesale price (AWP) for branded entecavir decreased approximately 60% between 2016 and 2022.

How are patent and regulatory landscapes affecting the market?

Patent expiry in 2016 led to increased generic competition. Regulatory approval pathways, including abbreviated new drug applications (ANDAs), facilitated rapid entry of generics.

Some regions, like the European Union, issued market exclusivity extensions for certain formulations, delaying generic entry. Biologics and biosimilars are not relevant for entecavir, as it is a small-molecule drug.

What are the future revenue projections for entecavir?

Based on current trends, the global market is forecasted to grow at a CAGR of around 4–6% through 2030, reaching approximately USD 400 million by 2030. Factors influencing this include:

• Increased screening and early detection initiatives.
• Development of combination therapies.
• Potential introduction of new formulations or delivery methods.

Price erosion from generics will persist but may plateau as market penetration stabilizes in mature regions.

What is the impact of emerging therapies on entecavir?

Newer hepatitis B treatments, such as tenofovir alafenamide and pegylated interferons, impact entecavir's market share. While these drugs target similar indications, competition varies by regional reimbursement policies:

• Tenofovir alafenamide shows better safety profiles in some populations.
• Entecavir remains preferred in certain guidelines due to efficacy and cost considerations.

Market share of entecavir may decline marginally but will remain significant due to established efficacy and formulary inclusion.

Closing Summary

Entecavir's market is shaped by high HBV prevalence, regional healthcare infrastructure, patent expiries, and competition from generics. While growth is slowing in mature markets, emerging economies contribute to continued revenue increases. Price competition remains intense, dictated by generic entry and healthcare policies.

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Key Takeaways

• The global entecavir market was valued at USD 250 million in 2022, with Asia-Pacific leading in sales and growth rates.
• Patent expirations in 2016 spurred rapid generic penetration, resulting in significant price reductions.
• The market is expected to grow at a CAGR of 4–6% through 2030, driven by increasing HBV screening and broader treatment access.
• Competition from newer therapies and generics will influence long-term market dynamics.
• Regional variations in reimbursement and regulatory policies are primary factors affecting revenue trajectories.

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FAQs

1. How does patent expiry influence entecavir’s market?
Patent expiry led to the entry of generics, reducing branded drug prices and expanding access, but decreasing overall revenue for original developers.

2. What regional factors impact entecavir sales?
Prevalence of hepatitis B, healthcare infrastructure, reimbursement policies, and regulatory environment determine regional sales volume and growth.

3. Are there significant upcoming patent protections for entecavir?
No, the original patent expired in 2016. No new patents or formulations are expected to extend exclusivity significantly.

4. How do newer hepatitis B therapies affect entecavir?
While tenofovir alafenamide and pegylated interferons offer alternative treatments, entecavir remains competitive due to cost, efficacy, and clinician familiarity.

5. What is the outlook for entecavir in low-income countries?
Market growth will depend on international health programs, affordability, and infrastructure development, with generics playing a critical role.

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References

1. Market Research Future. (2023). Hemophilia Drugs Market - Forecast to 2030. https://www.marketresearchfuture.com/reports/hepatitis-b-drug-market-8930
2. IQVIA. (2022). Market Trends in Hepatitis B Treatment.
3. U.S. Food and Drug Administration. (2016). Patent Expirations and Generic Entry Data.
4. WHO. (2022). Global hepatitis report.
5. EvaluatePharma. (2022). 2022 World Preview and Industry Outlook.