EPIVIR-HBV Drug Patent Profile

When do Epivir-hbv patents expire, and what generic alternatives are available?

Epivir-hbv is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in EPIVIR-HBV is lamivudine. There are twenty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the lamivudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epivir-hbv

A generic version of EPIVIR-HBV was approved as lamivudine by APOTEX on December 2^nd, 2011.

Summary for EPIVIR-HBV

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	46
Drug Prices:	Drug price information for EPIVIR-HBV
DailyMed Link:	EPIVIR-HBV at DailyMed

See drug prices for EPIVIR-HBV

Recent Clinical Trials for EPIVIR-HBV

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

Sponsor	Phase
Roswell Park Cancer Institute	Phase 2
Bess Frost, PhD	Phase 1/Phase 2
Owens Medical Research Foundation	Phase 1/Phase 2

See all EPIVIR-HBV clinical trials

US Patents and Regulatory Information for EPIVIR-HBV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998		DISCN	Yes	No
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998		DISCN	Yes	No

Expired US Patents for EPIVIR-HBV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	5,905,082*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	RE39155*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	5,047,407*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	RE39155*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	7,119,202*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	5,532,246*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	7,119,202*PED

EU/EMA Drug Approvals for EPIVIR-HBV

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Lamivudine Teva Pharma B.V.	lamivudine	EMEA/H/C/001111Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.	Authorised	yes	no	no	2009-12-10
Teva B.V.	Lamivudine Teva	lamivudine	EMEA/H/C/001113Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).	Authorised	yes	no	no	2009-10-23
GlaxoSmithKline (Ireland) Limited	Zeffix	lamivudine	EMEA/H/C/000242Zeffix is indicated for the treatment of chronic hepatitis B in adults with:, , , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;, decompensated liver disease in combination with a second agent without cross-resistance to lamivudine., ,	Authorised	no	no	no	1999-07-29
ViiV Healthcare BV	Epivir	lamivudine	EMEA/H/C/000107Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.,	Authorised	no	no	no	1996-08-08

International Patents for EPIVIR-HBV

See the table below for patents covering EPIVIR-HBV around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	9808060	composição farmacêutica, e, uso da lamivudina ou um seu derivado farmaceuticamente aceitável.
Cyprus	2036	Substitued-1,3-oxathiolanes with antiviral properties
Czech Republic	9903403
Czechoslovakia	9104109
South Korea	960007531
China	1044817
Bulgaria	64690

Supplementary Protection Certificates for EPIVIR-HBV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3494972	24C1024	France		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, INCLUANT LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
3494972	2024C/522	Belgium		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, MET INBEGRIP VAN DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
3494972	LUC00346	Luxembourg		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
0382526	19675032	Germany		PRODUCT NAME: LAMIVUDINE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH GEEIGNETEN SALZES; NAT. REGISTRATION NO/DATE: EU/1/96/015/001-002 19960808 FIRST REGISTRATION: CH 53662 53663 19960228
2924034	300981	Netherlands		PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126
0513917	C980018	Netherlands		PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318

Market Dynamics and Financial Trajectory for EPIVIR-HBV

Last updated: December 26, 2025

Executive Summary

EPIVIR-HBV (lamivudine) is a nucleoside analogue antiviral primarily used for the treatment of chronic hepatitis B virus (HBV) infection. It has historically played a significant role in HBV management, but market dynamics are shifting due to the advent of newer therapies, evolving treatment guidelines, and the broader hepatitis B treatment landscape. This analysis dissects the current market environment, forecasted financial trajectory, competitive positioning, regulatory factors, and strategic considerations for stakeholders engaged with EPIVIR-HBV.

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What is EPIVIR-HBV and its Therapeutic Role?

EPIVIR-HBV (lamivudine) is an antiviral medication approved for the treatment of chronic hepatitis B. It inhibits HBV DNA polymerase, reducing viral replication and liver inflammation. Since its FDA approval in 1998, lamivudine became a cornerstone of HBV therapy owing to its efficacy, oral administration, and affordability.

Key Specifications

Attribute	Details
Formulation	100 mg oral tablets
Mechanism of Action	Inhibits HBV DNA polymerase
Approved for	Chronic hepatitis B
Standard Dose	100 mg once daily
Treatment Duration	Long-term, often indefinite
Resistance Profile	High resistance rates (~70% after 5 years)

Source: [1], [2]

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Market Dynamics: Current Scenario

Market Penetration and Legacy Use

• Established Patient Base: Since 1998, millions of patients globally have been treated with lamivudine, forming a significant legacy cohort.
• Cost-Effectiveness: Affordable pricing positions EPIVIR-HBV as an attractive option in low- and middle-income countries (LMICs).
• Generic Availability: Patent expirations have led to multiple generics, further lowering prices and increasing accessibility.

Key Market Drivers

Driver	Impact
Global HBV Burden	Over 296 million people live with chronic HBV (WHO [3])
Cost-sensitive Healthcare Markets	High demand for low-cost, effective antivirals
Healthcare Infrastructure in LMICs	Facilitates widespread lamivudine use
Existing Clinical Guidelines	Inclusion as first-line or alternative therapy in various guidelines (e.g., WHO, AASLD)

Market Challenges

Challenge	Impact
Resistance Development	High resistance rates diminish long-term utility
Availability of Better Alternatives	Nucleos(t)ide analogs with higher barrier to resistance (e.g., entecavir, tenofovir) diminish EPIVIR-HBV attractiveness
Regulatory Shifts	Preference for newer, more potent agents in developed markets
Therapeutic Paradigm Changes	Shift toward finite, tailored therapy regimens

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Emerging Trends and Future Outlook

Resistance and Long-Term Efficacy

Resistance emergence (particularly YMDD mutations) limits lamivudine’s durability. Studies indicate ~70% resistance after five years of treatment [4].

Transition to Higher Barrier Drugs

Entecavir and tenofovir disoproxil fumarate (TDF) have become front-runners due to superior resistance profiles:

• Entecavir: Resistance rate <1% after 5 years [5]
• TDF: Minimal resistance reported [6]

Market Transition Dynamics

Trend	Implication
Declining Use in Developed Markets	Shift toward tenofovir and entecavir reduces EPIVIR-HBV prescriptions
Continued Use in LMICs	Remains a first-line due to low cost and established supply chain
Patent and Regulatory Landscape	Generics dominate in many regions; some markets may see regulatory obsolescence

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Financial Trajectory: Revenue and Market Projections

Historical Revenue Data

Year	Revenue (USD Millions)	Key Notes
2010	~$250	Predominantly in LMIC markets
2015	~$150	Decline attributed to newer agents' emergence
2020	<$50	Further declines as market shifts toward tenofovir and entecavir

Forecasted Market Trends (2023–2030)

Factor	Estimated Impact	Projections
Market shift toward TDF and entecavir	Continued decline in EPIVIR-HBV prescriptions	Decline of 50–60% over the next 5–7 years
Global HBV Treatment Expansion in LMICs	Sustained demand in underserved markets	Stable or modest declines; 3–5% CAGR residual
Generic Market Penetration	Price erosion and volume increase	Revenue plateau or slight growth in specific regions
New Therapeutic Developments	Competition from novel agents (e.g., capsid inhibitors)	Further market share erosion

Revenue Projections Summary

Year	Expected Revenue (USD Millions)	Notes
2023	~$25–30	Continued presence primarily in LMICs
2025	~$20–25	Market share reduction persists
2030	<$15	Potential further decline amid market evolution

Sources: Market Intelligence Reports (e.g., GlobalData, IQVIA), 2022–2023 projections

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Regulatory and Policy Influences

WHO Guidelines and National Policies

• WHO (Global Viral Hepatitis Strategy 2016–2021): Recommends tenofovir or entecavir over lamivudine due to higher resistance barriers [7].
• National Treatment Guidelines: Vary, with many shifting towards newer agents.
• Patent Status: Many regions permit generics, accelerating downward price trends.

Patent and Market Exclusivity

• Patent Expiry: Multiple formulations have no active patent protection, facilitating generic manufacturing.
• Regulatory Barriers: Varying approval processes influence market penetration in different countries.

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Competitive Landscape

Product	Type	Resistance Profile	Cost	Application Scope
Lamivudine (EPIVIR-HBV)	Nucleoside analogue	High (~70% after 5 years)	Low	Global, especially LMICs
Entecavir	Nucleoside analogue	<1% resistance after 5 years	Moderate to high	Developed markets, some LMICs
Tenofovir (TDF)	Nucleotide analogue	Very low resistance, broad activity	Moderate	Global, HIV co-infection contexts
Telbivudine	Nucleoside analogue	Higher resistance than entecavir	Moderate	Limited, specific markets

Note: Lamivudine's price advantage is offset by resistance issues, leading to declining use in favor of higher barrier drugs.

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Deep-Dive Comparison: EPIVIR-HBV vs. Competitors

Attribute	EPIVIR-HBV	Entecavir	Tenofovir Disoproxil Fumarate
Resistance Rate (5 Years)	~70%	<1%	<1%
Cost per Treatment (Annual)	<$50 (generic)	~$250–$500 (brand)	~$300–$500
Dosing Frequency	Once daily	Once daily	Once daily
Side Effect Profile	Mild, but lactic acidosis rare	Low, well tolerated	Potential renal toxicity
Long-Term Outcomes	High resistance limits efficacy	Superior durability	Highly effective, resistance minimal

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Key Considerations for Stakeholders

• Manufacturers: Focus on markets where generic proliferation sustains revenue; consider lifecycle management strategies.
• Healthcare Providers: Balance cost savings with resistance risks; adhere to evolving treatment guidelines.
• Policy Makers: Promote access through generics but also encourage transitioning to high barrier therapies.
• Investors: Anticipate steady decline in revenue in developed markets but sustained low-cost demand in LMICs.

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FAQs

1. Will EPIVIR-HBV remain relevant in the HBV therapeutic landscape?
While still used in certain low-resource settings, its relevance diminishes in high-income countries due to resistance concerns and established preference for tenofovir and entecavir.

2. How significant is resistance development in determining lamivudine’s market decline?
Extremely significant; approximately 70% of patients develop YMDD mutations after five years, undermining long-term efficacy.

3. Are there new formulations or combination therapies involving lamivudine?
Limited; current research focuses on agents with a higher barrier to resistance. Lamivudine mainly persists as a component of existing combination regimens in certain settings.

4. What is the geographical variation in EPIVIR-HBV usage?
Most prevalent in LMICs, where affordable generics enable continued use; declining in high-income regions due to guideline shifts.

5. Can EPIVIR-HBV usage pick up with new indications?
Unlikely; the current focus is on more advanced therapies. No significant expansion of indications is anticipated given resistance issues and competition.

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Key Takeaways

• Declining Revenue: EPIVIR-HBV’s market revenue is contracting due to resistance issues and the availability of superior alternatives.
• Sustained Market in LMICs: Cost advantages and generics ensure continued, albeit reduced, use primarily in resource-limited settings.
• Resistance is the Major Limiting Factor: High resistance rates diminish long-term viability, prompting shifts toward tenofovir and entecavir.
• Policy Evolution: Global guidelines increasingly favor higher barrier drugs, accelerating the phase-out of lamivudine.
• Market Strategy Implication: Stakeholders should pivot focus toward portfolio diversification, especially in therapeutic agents with higher resistance barriers.

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References

[1] World Health Organization. (2017). Hepatitis B Fact Sheet.

[2] Lok, A.S., & McMahon, B.J. (2009). Chronic Hepatitis B: Update 2009. Hepatology, 50(3), 661-662.

[3] World Health Organization. (2022). Global Hepatitis Report 2022.

[4] Wong, D.K., et al. (2004). Antiviral resistance mutation YMDD sequences in lamivudine-treated patients. J. Hepatol, 40(2), 228–234.

[5] European Association for the Study of the Liver. (2017). EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection.

[6] Marcellin, P., et al. (2008). Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med, 359(23), 2442-2455.

[7] World Health Organization. (2016). Global Viral Hepatitis Strategy 2016–2021.

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This comprehensive review provides critical insights for pharmaceutical stakeholders, healthcare providers, and policymakers aiming to navigate the evolving landscape of HBV therapeutics.