EPIVIR Drug Patent Profile

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

Epivir is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs.

The generic ingredient in EPIVIR 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

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

Summary for EPIVIR

US Patents:	0
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	46
Patent Applications:	480
Drug Prices:	Drug price information for EPIVIR
What excipients (inactive ingredients) are in EPIVIR?	EPIVIR excipients list
DailyMed Link:	EPIVIR at DailyMed

See drug prices for EPIVIR

Recent Clinical Trials for EPIVIR

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 clinical trials

Pharmacology for EPIVIR

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

US Patents and Regulatory Information for EPIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	AA	RX	Yes	Yes
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998		DISCN	Yes	No
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	AB	RX	Yes	No
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	AB	RX	Yes	Yes
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998		DISCN	Yes	No

Expired US Patents for EPIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995

EU/EMA Drug Approvals for EPIVIR

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

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

Country	Patent Number	Title	Estimated Expiration
Poland	293181
Croatia	P940040	SUBSTITUTED-1,3-OXATHIOLANES WITH ANTIVIRAL PROPERTIES
Hong Kong	51997	Substituted -1,3-oxathiolanes with antiviral properties
African Regional IP Organization (ARIPO)	9200395
World Intellectual Property Organization (WIPO)	9414802
Croatia	P940041	1,3-OXATHIOLANE NUCLEOSIDE ANALOGUES
Canada	1339609	DERIVES DE SUBSTITUTION EN 2 ET EN 4 DE 1,3-DIOXOLANES; SYNTHESE ET UTILISATION (2-SUBSTITUTED-4-SUBSTITUTED-1, 3-DIOXOLANES, SYNTHESIS AND USE THEREOF)

Supplementary Protection Certificates for EPIVIR

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
2924034	CR 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EPIVIR

Last updated: July 28, 2025

Introduction

EPIVIR (lamivudine) remains a cornerstone in the management of HIV and hepatitis B virus (HBV) infections. Its global market trajectory has been shaped by advancements in antiviral therapies, evolving regulatory landscapes, patent expirations, and emerging competition. This analysis evaluates the current market dynamics and projective financial trajectory of EPIVIR, emphasizing key factors influencing its market position and revenue streams over the near to mid-term.

Historical Market Context

Launched in the early 1990s, EPIVIR introduced a highly effective nucleoside reverse transcriptase inhibitor (NRTI) for HIV therapy. Over time, it gained inclusion in first-line treatment regimens thanks to its efficacy and safety profile. Its broad-spectrum activity against HBV further expanded its therapeutic scope, facilitating market penetration across multiple indications [1].

The patent protections for EPIVIR extended significant market exclusivity, allowing for premium pricing. However, as patents expired, generic versions entered global markets, precipitating a notable decline in branded sales. The introduction of newer, potent, and combination therapies further eroded its market share in HIV, with competitors offering fixed-dose combinations (FDCs) that integrated lamivudine with other agents.

Market Dynamics

1. Patent Expiry and Generic Competition

EPIVIR’s patent expiry in key markets—most notably the United States in 2008 and Europe in 2010—marked a significant shift in its market landscape. Generic manufacturers rapidly introduced bioequivalent versions, resulting in substantial price reductions—up to 80%—and increased access in low- and middle-income regions.

The influx of generics caused a sharp decline in revenues for branded EPIVIR. This trend underscores a broader pattern where patent cliffs diminish exclusivity, compelling branded manufacturers to diversify or innovate to retain profitability.

2. Growing Adoption of Fixed-Dose Combinations

Recent trends favor FDCs that incorporate lamivudine alongside other antiretrovirals such as tenofovir and emtricitabine. These products enhance patient adherence, simplify treatment regimens, and are often favored by clinicians and payers. Consequently, sales of standalone EPIVIR tablets decline further as FDCs supplant monotherapy approaches in HIV management.

3. Shifts in Treatment Guidelines and Emerging Competitors

Global treatment guidelines now prioritize drugs with higher genetic barriers to resistance and improved safety profiles. Drugs like tenofovir alafenamide (TAF) and bictegravir have gained prominence, reducing EPIVIR’s prescription volume.

Additionally, newer agents demonstrate less toxicity and better tolerability, influencing prescriber preferences away from lamivudine. This shifting landscape further constrains EPIVIR’s market share, especially in high-income countries where regulatory adoption aligns with cutting-edge therapies.

4. Expansion in Low- and Middle-Income Markets

Despite declining in high-income regions, EPIVIR maintains relevance in low- and middle-income markets due to its affordability and fixed-dose formulations. WHO prequalification and inclusion in essential medicines lists sustain demand. Generic manufacturers’ affordability strategies and international procurement agencies (e.g., Global Fund) facilitate continued volume sales.

5. Regulatory and Patent Strategies

Strategies such as patent evergreening and regulatory exclusivities in some jurisdictions temporarily delay generic entry. However, in many regions, patent expirations have opened the market for permutations and biosimilars, intensifying price competition.

Financial Trajectory Analysis

1. Revenue Trends Post-Patent Expiry

Historical data indicates a steep decline in branded EPIVIR revenues following patent expiration. Pfizer, the original manufacturer, saw its HIV franchise's share diminish substantially as generics flooded the market. The revenue drop was compounded by the transition towards combination therapies, reducing standalone lamivudine sales.

2. Current Revenue Sources

Today, EPIVIR’s primary revenue derives from volume sales in low-to-middle income countries and prophylactic usage related to HBV. The product’s role in multidrug regimens is largely replaced by newer agents; however, its affordability makes it a mainstay in treatment programs with budget constraints.

3. Impact of Competition and Market Saturation

The proliferation of generic lamivudine products has driven prices down globally. This commoditization shrinks profit margins and challenges the sustainability of branded sales, demanding strategic diversification from manufacturers.

4. Future Outlook: Sales and Market Share Projection

Projections suggest a continued decline in standalone EPIVIR revenue over the next 5-7 years, driven by:

• The dominance of combination drugs with newer agents.
• Increasing uptake of integrase inhibitor-based regimens.
• Further patent expirations and generic entry in new markets.

However, in specific niches—such as HBV monotherapy in resource-limited settings—EPIVIR is poised to sustain stable volume sales, albeit at lower revenue levels.

5. Licensing and Reformulation Opportunities

Companies may explore formulations, such as pediatric versions or fixed-dose combinations, to extend product lifecycle and revenue. Licensing agreements with generic firms could maximize market penetration while maintaining controlled royalties for innovator firms.

Implications for Stakeholders

• Pharmaceutical Companies: Strategies must emphasize diversification through innovating new antivirals, developing combination formulations, or expanding into diagnostic and preventative markets to compensate for declining EPIVIR revenues.

• Investors: A cautious outlook is warranted for brands suffering from patent expiration effects, with a focus on pipeline strength and emerging portfolio assets for sustained growth.

• Healthcare Payers: Price sensitivity and generic availability will continue to pressure margins; procurement strategies favor low-cost generics in epidemic-prone regions.

• Regulatory Bodies: Guidelines shifting toward newer agents may continue constricting EPIVIR’s market access unless repurposed for niche indications or reformulations.

Conclusion

The market dynamics for EPIVIR have undergone profound transformation from monopoly-driven profitability to a generic, volume-driven landscape. While its role in global HIV and HBV treatment remains significant in certain contexts, the financial trajectory points toward a gradual decline in branded revenues. Stakeholders must adapt through innovation, strategic alliances, and emphasizing underserved markets to mitigate the impacts of patent expirations and fierce competition.

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Key Takeaways

• Patent expiration and generic competition have profoundly diminished branded EPIVIR revenues, shifting reliance toward volume-based sales, predominantly in resource-limited regions.
• The rise of fixed-dose combination therapies and newer antivirals has relegated standalone lamivudine to a niche role, affecting its financial prospects.
• Market diversification, through reformulations or broader HIV/HBV treatment portfolios, is essential to sustain returns.
• Emerging global health initiatives continue to support EPIVIR in underserved markets, underpinning stable volume sales despite declining revenue margins.
• Future success hinges on strategic innovation and market adaptation to evolving treatment standards and competitive pressures.

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FAQs

Q1: Will EPIVIR regain market dominance with new formulations?
Unlikely, given the preference for newer agents with improved safety and resistance profiles. Reformulations may sustain niche demand but are insufficient to restore dominant market position.

Q2: How do patent expirations impact EPIVIR's pricing?
Expirations lead to increased generic entries, drastically reducing prices and profit margins for branded versions.

Q3: What are the primary markets for EPIVIR today?
Low- and middle-income countries continue to represent primary markets due to affordability and procurement via international agencies.

Q4: Is EPIVIR still a viable treatment option in high-income countries?
In most high-income regions, EPIVIR is phased out in favor of newer, more effective drugs in favor of combination therapies with higher barriers to resistance.

Q5: What is the outlook for EPIVIR in HBV treatment?
It maintains relevance, especially where cost constraints limit access to newer agents, ensuring steady but modest demand.

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Sources:

[1] World Health Organization. (2020). Guidelines on hepatitis B and C testing.
[2] IMS Health. (2018). Global HIV & Hepatitis Market Analysis.
[3] Pfizer Annual Reports. (2008–2022).
[4] Global Data. (2022). Antiviral Market Trends.