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. Fifteen 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
Finished Product Suppliers / Packagers:	1
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
Owens Medical Research Foundation	Phase 1/Phase 2
Bess Frost, PhD	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	RE39155*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	RE39155*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	7,119,202*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	5,047,407*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	5,532,246*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	5,047,407*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
Croatia	P940040	SUBSTITUTED-1,3-OXATHIOLANES WITH ANTIVIRAL PROPERTIES
Hong Kong	51997	Substituted -1,3-oxathiolanes with antiviral properties
African Regional IP Organization (ARIPO)	1141	A pharmaceutical composition comprising lamivudine or its derivatives that can be effectively preserved by parabens.
Australia	1153492
Germany	69232387
United Kingdom	9111902

Supplementary Protection Certificates for EPIVIR-HBV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2924034	2019C/005	Belgium		PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, 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; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
2924034	2019/021	Ireland		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122
2924034	LUC00114	Luxembourg		PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC LA LAMIVUDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC DU TENOFOVIR OU UN DE SES ESTERS, EN PARTICULIER UN ESTER DE DISOPROXIL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SEL DE FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1333 20181126
0382526	SZ 22/1996	Austria		PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE
0382526	SPC/GB96/043	United Kingdom		PRODUCT NAME: LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH 53662 19960228; CH 53663 19960228; UK EU/1/96/015/001 19960808; UK EU/1/96/015/002 19960808
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703

Market Dynamics and Financial Trajectory for EPIVIR-HBV

Last updated: July 28, 2025

Introduction

EPIVIR-HBV, the branded formulation of lamivudine, is a cornerstone antiviral medication targeting chronic hepatitis B virus (HBV) infection. Approved by global regulatory agencies over two decades ago, it plays a vital role in HBV management. Its market trajectory reflects evolving treatment paradigms, patent status, competition, and emerging therapeutic alternatives. This article analyzes the current market landscape, future growth prospects, and financial implications for EPIVIR-HBV within the broader antiviral industry.

Pharmacological Profile and Clinical Role

EPIVIR-HBV is a nucleoside analog reverse transcriptase inhibitor (NRTI) that effectively suppresses HBV DNA, reducing disease progression and associated morbidity. Its favorable safety profile historically established it as a first-line therapy, especially in resource-limited settings. However, the emergence of newer agents with higher resistance barriers and better efficacy has gradually reshaped its clinical positioning.

Market Dynamics

Patent Expiry and Generic Competition

The initial patent of EPIVIR-HBV expired in many jurisdictions, fostering an influx of generic versions. Generic entry typically precipitates price erosion, expanding access but compressing revenue for originators. Nonetheless, the drug’s widespread adoption and long-standing use sustain residual brand-driven markets, especially in regions emphasizing brand trust or limited generic penetration.

Competitive Landscape: Emerging Therapies

The HBV treatment landscape has shifted markedly, with novel agents like tenofovir disoproxil fumarate (TDF), entecavir, and recent entry of agents like tenofovir alafenamide (TAF) offering higher potency and resistance profiles. These improvements have led to a decline in EPIVIR-HBV prescriptions in favor of newer therapies perceived as more effective and safer. Additionally, agents targeting different viral life cycle stages, or combination regimens, threaten to further diminish EPIVIR-HBV’s market share.

Regulatory and Policy Influences

Global health policies prioritizing accessible hepatitis B treatment have increased generic uptake, especially in low- and middle-income countries. International organizations like WHO recommend tenofovir and entecavir over lamivudine due to resistance concerns, affecting EPIVIR-HBV’s market share. Conversely, in countries with fixed formularies or limited regulatory approvals for newer agents, EPIVIR-HBV retains a significant market presence.

Price Sensitivity and Regional Variations

Price elasticity varies geographically. In high-income nations, payers favor newer agents, often leading to low EPIVIR-HBV utilization. Contrastingly, low-income countries often rely on generics, sparing EPIVIR-HBV from immediate obsolescence and providing sustainable, albeit reduced, revenue streams.

Financial Trajectory

Revenue Trends

Historically, EPIVIR-HBV contributed substantial revenues for its patent holder, with peak sales in the early 2000s. After patent expiry, revenues declined sharply, paralleling the global trend of generic penetration. Despite this, ongoing use in certain regions sustains residual revenue, primarily from generic licensing.

Market Share Evolution

The shift towards tenofovir and entecavir globally has led to a steady erosion of EPIVIR-HBV’s market share. Analysts project marked declines over the next decade as newer therapies become standard. However, in specific markets with limited access to generics or alternative therapies, EPIVIR-HBV maintains relevance, providing steady cash flows nonetheless.

Pricing and Cost Advantages

Generic availability has significantly reduced prices, making EPIVIR-HBV attractive for large-scale chronic hepatitis B programs. This dynamic supports sustained volume sales, offsetting lower per-unit revenue, particularly in low-resource settings.

Patent Strategy and Brand Management

Limited patent protections or secondary patents can influence the financial trajectory. Companies may pursue patent extensions or combination formulations to maintain market exclusivity, thus stabilizing revenues temporarily. However, widespread patent expirations remain a critical factor constraining profit margins.

Impact of Patent Litigation and Regulatory Changes

Legal disputes over patent rights and regulatory policies promoting generic substitution modify the financial landscape. Countries implementing compulsory licensing further diminish revenue potential, especially in the context of public health initiatives.

Future Outlook

Potential for Formulation and Combination Therapy Development

Strategies focusing on combination therapies or novel delivery systems could rejuvenate interest. For example, fixed-dose combinations including lamivudine with other antivirals could offer simplified regimens, potentially extending EPIVIR-HBV’s market viability in niche segments.

Role in Early Treatment and Resistance Management

EPIVIR-HBV’s low resistance barrier compared to newer agents limits its use in monotherapy for long-term management. Nonetheless, it remains valuable in certain contexts, including short-term settings and as part of combination strategies.

Emerging Innovative Therapies

The pipeline of novel agents such as capsid assembly inhibitors, siRNA-based therapies, and immune modulators may eventually eclipse lamivudine derivatives globally. Their development could further diminish EPIVIR-HBV’s market share unless it finds a niche in combination therapy or specific patient populations.

Market Opportunities in Low-resource Settings

Despite global shifts, the low-cost nature of generics ensures continued demand in developing economies. Governments and NGOs prioritize affordable treatments, bolstering EPIVIR-HBV’s long-term prospects in these regions.

Key Takeaways

• Declining Market Share: The expiration of EPIVIR-HBV’s patents and the advent of superior antivirals have led to a significant decline in its market share globally, though residual demand persists in specific regions.

• Price-driven Market Sustainability: Generic competition has reduced prices, allowing large-scale public health programs to sustain high-volume sales, especially in resource-limited settings.

• Competitive Threats: Newer agents like tenofovir and entecavir are preferred due to higher efficacy and resistance profiles, further constraining EPIVIR-HBV’s growth.

• Strategic Opportunities: Formulation innovations and niche applications could provide temporary market extensions, but the long-term outlook hinges on disruptor therapies entering the market.

• Regional Variations: Market dynamics are highly regional, with high-income countries favoring newer therapies, and low-income nations relying heavily on affordable generics, supporting EPIVIR-HBV’s ongoing relevance.

Conclusion

EPIVIR-HBV’s financial trajectory reflects a classical lifecycle pattern of early dominance followed by gradual decline due to patent expirations and evolving therapeutic standards. While global revenues diminish, the drug continues to serve vital roles in specific markets. Stakeholders must navigate patent landscapes, regulatory environments, and competitive innovations to optimize value extraction. Long-term success depends on strategic positioning within niche markets and potential adaptations to therapeutic advancements.

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FAQs

1. Will EPIVIR-HBV regain prominence with new formulations?
Current evidence suggests that formulation reforms alone are unlikely to restore its prominence. The fundamental challenges stem from competition with higher-efficacy, resistance-resistant agents and shifting treatment guidelines favoring newer therapies.

2. How does patent expiration influence EPIVIR-HBV's market dynamics?
Patent expiry accelerates generic entry, leading to price reductions and volume-driven sales in resource-limited markets, but diminishes income from brand-specific sales, challenging profitability for originators.

3. Are there health policy initiatives favoring EPIVIR-HBV over newer drugs?
In many developing countries, procurement policies favor low-cost generics, including EPIVIR-HBV, supporting its use despite the availability of newer drugs elsewhere.

4. What role might EPIVIR-HBV play in combination therapy?
While primarily replaced as monotherapy, EPIVIR-HBV could be integrated into combination regimens, especially where cost constraints limit access to newer agents, though resistance issues may limit this role.

5. What is the outlook for EPIVIR-HBV in the next decade?
Its market is expected to contract further globally; however, in niche markets and public health programs in developing countries, it will likely remain in use, supported by affordability and infrastructure factors.

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References

[1] World Health Organization. (2017). Guidelines for the Prevention, Care and Treatment of Persons with Chronic Hepatitis B Infection.
[2] Kundu, S. et al. (2020). "Global Market Trends in HBV Therapeutics." Pharmaceutical Business Review.
[3] U.S. Food & Drug Administration. (2005). Lamivudine FDA Approval Documents.
[4] IMS Health. (2019). Global Antiviral Market Report.
[5] WHO. (2022). Global Health Observatory (GHO) Data on Hepatitis B.