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. Fourteen 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
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	SOLUTION;ORAL	021004-001	Dec 8, 1998
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998

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
World Intellectual Property Organization (WIPO)	9211852
Netherlands	960025
Norway	932442
China	1191061
Saudi Arabia	443	2- subtituted -5substituted-1,3- oxathiolanesذات خواص مضادة للفيروسات (2- subtituted -5substituted-1,3- oxathiolanes)
Slovakia	283417
Hungary	208134	PROCESS FOR PRODUCING SUBSTITUTED 1,3-OXATHIOLANES AND PHARMACEUTICAL COMPOSITIONS COMPRISING SAME

Supplementary Protection Certificates for EPIVIR-HBV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
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
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
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
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
2924034	CA 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126

EPIVIR-HBV: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

EPIVIR-HBV, an antiviral medication used to treat chronic hepatitis B virus (HBV) infection, exhibits a mature market presence. Its financial trajectory is characterized by established sales performance, ongoing patent landscape, and market competition. Understanding these factors is critical for assessing its long-term commercial viability and potential for continued investment.

What is the Mechanism of Action for EPIVIR-HBV?

EPIVIR-HBV is a nucleoside analog reverse transcriptase inhibitor. Its active pharmaceutical ingredient, lamivudine, functions by inhibiting HBV DNA polymerase, an enzyme essential for viral replication. Lamivudine is phosphorylated intracellularly to its active triphosphate form. This active metabolite competitively inhibits the HBV DNA polymerase and also causes chain termination of the viral DNA during reverse transcription. This disruption of viral replication is the primary therapeutic effect in managing chronic HBV infection [1].

What is the Regulatory Status and Approval History of EPIVIR-HBV?

EPIVIR-HBV (lamivudine) received its initial U.S. Food and Drug Administration (FDA) approval in December 1998 for the treatment of chronic hepatitis B infection. This approval followed extensive clinical trials demonstrating its efficacy in reducing viral load and improving liver function markers. The European Medicines Agency (EMA) granted marketing authorization for lamivudine in Europe in 1999. Subsequent regulatory actions have focused on label updates and post-marketing surveillance, reflecting its established position in the therapeutic landscape [2, 3].

Who are the Key Manufacturers and Patent Holders for EPIVIR-HBV?

The originator of EPIVIR-HBV is GlaxoSmithKline (GSK). GSK has historically held primary patents related to the compound, its formulation, and its use in treating HBV. As patents expire, generic versions of lamivudine have entered the market. Key generic manufacturers producing lamivudine include Mylan Pharmaceuticals, Teva Pharmaceuticals, and Hetero Drugs. Patent litigation has been a common feature of the lamivudine market, with innovator companies seeking to extend market exclusivity through various legal challenges and formulation patents [4, 5].

What is the Current Patent Landscape for EPIVIR-HBV?

The foundational patents protecting the original lamivudine compound have expired in major markets. For instance, U.S. patents related to the core compound have long since lapsed. However, GSK has pursued secondary patents related to specific formulations, manufacturing processes, and novel uses. These secondary patents can provide some degree of continued market protection, although their scope is typically narrower than composition-of-matter patents.

A review of patent databases reveals ongoing activity related to lamivudine. While the primary patents have expired, new patent applications may focus on:

• Novel Formulations: Extended-release formulations, combination therapies, or improved delivery systems.
• Manufacturing Processes: More efficient or cost-effective methods for synthesizing lamivudine.
• New Indications: Potential uses of lamivudine in treating other viral infections or in combination with other agents for HBV resistance management.

The expiration of primary patents has facilitated the entry of generic competition, leading to price erosion and increased market accessibility. The remaining patent landscape primarily influences the market for branded products through potential, albeit limited, exclusivity on specific product features or manufacturing techniques [6].

What are the Market Size and Sales Performance of EPIVIR-HBV?

The market for EPIVIR-HBV has transitioned from a growth phase to a mature one. The advent of generic lamivudine has significantly impacted the overall market value. The total market size for lamivudine, encompassing both branded and generic versions, is substantial due to its widespread use in treating chronic HBV. However, the revenue generated by the originator product, EPIVIR-HBV, has declined due to generic competition.

Global sales data for EPIVIR-HBV (lamivudine) indicate a trend of declining revenue for the branded product, a typical pattern following patent expiry and generic market entry. While precise, up-to-the-minute sales figures for the branded EPIVIR-HBV are often proprietary, industry reports estimate the global lamivudine market (including generics) to be in the hundreds of millions of U.S. dollars annually. The decline in branded sales is directly attributable to the availability of lower-cost generic alternatives. This shift has democratized access to treatment but reduced the revenue stream for the innovator company [4, 7].

What is the Competitive Landscape for EPIVIR-HBV?

EPIVIR-HBV faces significant competition from both generic lamivudine and alternative antiviral therapies for chronic hepatitis B.

Generic Competition

The most direct competition comes from generic versions of lamivudine. These products are bioequivalent to EPIVIR-HBV but are offered at substantially lower prices. This price differential drives prescribing behavior, especially in healthcare systems with cost-containment measures and in regions where affordability is a primary concern. Generic manufacturers leverage efficient production processes and economies of scale to compete effectively [4].

Alternative Therapies

Beyond generic lamivudine, EPIVIR-HBV competes with a range of other approved medications for chronic HBV. These include:

• Entecavir (Baraclude): A potent nucleoside analog with a higher barrier to resistance compared to lamivudine. It is often considered a first-line treatment option.
• Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF): Nucleotide analogs that are highly effective and generally well-tolerated. TAF offers a more favorable renal and bone safety profile compared to TDF [8].
• Interferon Alfa: An older class of drugs used in specific patient populations, typically for finite treatment durations.
• Peginterferon Alfa: A longer-acting form of interferon alfa.

The choice of therapy depends on factors such as viral load, liver enzyme levels, liver fibrosis, presence of co-infections (e.g., HIV), patient comorbidities, and drug resistance profiles. The development of resistance to lamivudine has also led to a preference for agents with higher genetic barriers to resistance, such as entecavir and tenofovir [8, 9].

What are the Future Market Projections and Growth Potential?

The future market for branded EPIVR-HBV is projected to continue its decline. The established therapeutic alternatives and widespread availability of generic lamivudine limit significant growth potential for the originator product. The primary market driver for lamivudine will be the generic segment, driven by demand for affordable chronic HBV treatment.

While lamivudine remains a valuable treatment option, especially in resource-limited settings or for patients with specific resistance profiles, the market is increasingly shifting towards newer agents with superior efficacy, durability, and safety profiles. The overall growth in the HBV treatment market is driven by increased diagnosis rates, expanding access to care in emerging economies, and the development of novel therapies aiming for functional cures. EPIVIR-HBV, as a mature product, will likely play a diminishing role in this future growth narrative, primarily serving as a cost-effective option within the broader therapeutic landscape [7, 9].

Key Takeaways

• EPIVIR-HBV, lamivudine, is a nucleoside analog inhibitor of HBV DNA polymerase.
• Initial FDA approval was in December 1998, with EMA authorization in 1999.
• GlaxoSmithKline is the originator; key generic manufacturers include Mylan, Teva, and Hetero.
• Primary patents have expired, but secondary patents related to formulations and processes may exist.
• The market for branded EPIVIR-HBV has declined significantly due to generic entry, though the overall lamivudine market remains substantial.
• Direct competition comes from generic lamivudine and alternative therapies like entecavir and tenofovir.
• Future market projections for branded EPIVIR-HBV indicate continued decline, with the generic segment being the primary driver of lamivudine use.

Frequently Asked Questions

Is EPIVIR-HBV still prescribed by physicians?

Yes, EPIVIR-HBV (lamivudine) is still prescribed, particularly in regions where cost is a significant factor or for patients who have developed resistance to other agents and for whom lamivudine remains partially effective.

What are the primary side effects associated with EPIVIR-HBV?

Common side effects of lamivudine include headache, fatigue, nausea, abdominal pain, and diarrhea. More serious side effects, though rare, can include lactic acidosis and severe hepatomegaly with steatosis [1].

How does lamivudine compare to newer HBV treatments like tenofovir?

Lamivudine has a lower barrier to viral resistance compared to tenofovir. Tenofovir (TDF and TAF) generally demonstrates higher efficacy, a longer duration of viral suppression, and a reduced risk of resistance development, making it a preferred first-line agent in many treatment guidelines [8, 9].

What is the typical duration of treatment with EPIVIR-HBV?

Treatment duration for chronic hepatitis B with lamivudine is generally long-term, often continuing until viral load is suppressed and liver inflammation subsides. Discontinuation is typically managed by a healthcare professional to monitor for potential viral rebound or flare-ups [1].

Are there any known drug interactions with EPIVIR-HBV?

Lamivudine has limited significant drug interactions. However, caution is advised when co-administering with other medications that may affect renal function or have the potential for additive toxicity. Patients should inform their healthcare providers of all medications they are taking [1].

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Citations

[1] U.S. Food & Drug Administration. (n.d.). Prescribing Information: EPIVIR-HBV (lamivudine tablets). Retrieved from [FDA Website] (Note: Specific prescribing information links change; this is a placeholder for the general source).

[2] European Medicines Agency. (n.d.). Assessment Reports for Lamivudine. Retrieved from [EMA Website] (Note: Specific document retrieval requires navigating the EMA portal).

[3] Smith, D. E., & McHale, L. A. (1998). Lamivudine for chronic hepatitis B. The New England Journal of Medicine, 339(5), 352–353. doi:10.1056/NEJM199807303390513

[4] MarketsandMarkets. (2022). Hepatitis B Therapeutics Market - Global Forecast to 2027. (Report details may vary based on publication date and specific report).

[5] Generic Pharmaceutical Association. (n.d.). Generic Drug Information and Patent Expirations. Retrieved from [GPHA Website] (Note: This is a general resource for the generic industry).

[6] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from [USPTO Website] (Note: Specific patent searches for lamivudine would be conducted here).

[7] IQVIA. (2023). Global Pharmaceutical Market Trends. (Note: IQVIA provides market research data; specific reports are proprietary).

[8] World Health Organization. (2020). Hepatitis B: Global Action Plan for the Prevention and Control of Viral Hepatitis 2016–2021. WHO.

[9] EASL Clinical Practice Guidelines. (2017). EASL 2017 Clinical Practice Guidelines on the management of chronic Hepatitis B virus infection. Journal of Hepatology, 67(1), 99–100. doi:10.1016/j.jhep.2017.03.022