EPIVIR-HBV Drug Patent Profile

Which patents cover Epivir-hbv, and when can generic versions of Epivir-hbv launch?

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

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

International Patents for EPIVIR-HBV

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

Country	Patent Number	Title	Estimated Expiration
Tajikistan	249	1,3-Oxathiolane nucleoside analogues their use
Panama	8449301	COMPOSICIONES FARMACEUTICAS
Greece	3017812
China	1191061
Japan	H06507150
Ireland	73642	Medicaments
Portugal	93094	PROCESSO PARA A PREPARACAO DE 1,3-OXATIOLANOS SUBSTITUIDOS E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM

Supplementary Protection Certificates for EPIVIR-HBV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2924034	SPC/GB19/024	United Kingdom		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL; REGISTERED: UK EU/1/18/1333/001-002 20181122; UK PLGB 5305/0015 20181122
3494972	202440019	Slovenia		PRODUCT NAME: DOLUTEGRAVIR OR ITS PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING SODIUM DOLUTEGRAVIR, AND LAMIVUDINE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1370; DATE OF NATIONAL AUTHORISATION: 20190701; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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
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	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	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703

Overview

Last updated: February 9, 2026

EPIVIR-HBV, containing lamivudine as its active ingredient, is used to treat chronic hepatitis B virus (HBV) infection. It is marketed by GlaxoSmithKline (GSK) as a generic version of the branded drug Epivir HBV. The drug has faced changing market dynamics due to the development of more potent antivirals with fewer resistance issues. This report evaluates the current investment landscape and fundamental factors influencing EPIVIR-HBV.

Market Position and Competition

• Market Size: The global chronic hepatitis B market was valued at approximately $4 billion in 2022, projected to grow at 3.5% CAGR through 2030.[1]
• Reimbursement: High reimbursement rates in developed markets for hepatitis B treatments support steady revenue streams.
• Competitors: Tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) dominate due to higher barriers to resistance and improved safety profiles.
• Generic Impact: As a generic, EPIVIR-HBV faces pricing pressures but benefits from established manufacturing and distribution channels.

Regulatory and Patent Landscape

• Patent Status: GSK's patent for Epivir HBV expired in key markets (e.g., US 2018, EU 2019). Generic versions have entered the market, pressuring prices.
• Regulatory Certifications: EPIVIR-HBV is approved in over 50 countries, with regulatory stability in major markets.
• Potential New Formulations: No recent filings suggest upcoming reformulations or line extensions.

Pricing and Revenue Fundamentals

Parameter	Details
Average Wholesale Price (AWP)	Approx. $70–$100 per 30-day supply in the US
Estimated Annual Revenue (US)	~$150 million (pre-competition decline)
Market Share (generic HBV drugs)	Estimated 20–25% in developed markets
Price Trends	Declined 30–50% over the last five years

Generics have led to significant price erosion, reducing margins. As patent protections have expired or faced legal challenges, revenues have declined accordingly.

R&D and Lifecycle Outlook

• No recent pipeline developments or clinical trials suggest limited innovation or lifecycle extension prospects for EPIVIR-HBV.
• The shift toward TAF, which has a better resistance profile and fewer renal or bone safety issues, diminishes future growth potential for lamivudine-based treatments.
• Resistance development remains a concern, with long-term use of lamivudine (EPIVIR-HBV) associated with high rates of resistance (~70% after 5 years).[2]

Financial Performance and Investment Implications

• Revenue Trends: Sales have plateaued and declined due to generic competition and price erosion.
• Profitability: Margins compressed, with limited room for price increases given competitive pressures.
• Legal Risks: Patent challenges and patent cliffs pose ongoing threats.
• Market Outlook: Weak growth prospects without innovation or reformulation.

Strategic Considerations

• Acquisition or Licensing: High-risk, low-reward due to market saturation and declining revenues.
• Portfolio Diversification: Limited relevance outside HBV treatment, reducing strategic value.
• Investment Timing: Favorable during patent exclusivity; risky post-patent expiration.

Key Takeaways

1. EPIVIR-HBV's market is shrinking due to generic competition and shifts to more advanced antivirals, especially TAF.
2. Revenues have declined sharply, with no significant pipeline or reformulation plans in sight.
3. Resistance issues and safety profile limitations further limit future growth.
4. Legal and patent expiry risks remain minimal but are ongoing concerns.
5. Investment in EPIVIR-HBV is primarily appropriate as a short-term revenue asset during patent protection; long-term prospects are poor.

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FAQs

1. Is EPIVIR-HBV a good investment currently?
No. The drug faces declining revenues due to generic competition, resistance issues, and newer treatments outperforming it.

2. Are there any pipeline opportunities for EPIVIR-HBV?
No. GSK has not announced significant development efforts or reformulations for EPIVIR-HBV.

3. How does resistance impact EPIVIR-HBV’s marketability?
High resistance rates (up to 70% over five years) diminish long-term effectiveness, reducing its relevance compared to newer antivirals.

4. What is the competitive landscape for HBV drugs?
Tenofovir disoproxil fumarate and tenofovir alafenamide dominate, offering better safety profiles and resistance resistance, marginalizing lamivudine-based drugs.

5. What could extend EPIVIR-HBV’s lifecycle?
Potential reformulations or combination therapies, but none are currently in development or market filings.

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References

[1] Market Research Future. "Hepatitis B Virus Market Analysis." 2022.
[2] Dienstag, J. "Long-term Resistance to Lamivudine in Chronic Hepatitis B." Hepatology, 2003.