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:	2
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	46
Patent Applications:	2,597
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

Pharmacology for EPIVIR-HBV

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-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
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	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	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/001111 Lamivudine 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/001113 Lamivudine 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/000242 Zeffix 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/000107 Epivir 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
Slovenia	0969815
Canada	2254613
Germany	69232387
Czech Republic	9903403
Ireland	73642	Medicaments
Australia	1736192
New Zealand	232421	PURINE OR PYRIMIDINE SUBSTITUTED 1,3-OXATHIOLANE DERIVATIVES; PREPARATORY PROCESS, INTERMEDIATES AND PHARMACEUTICAL COMPOSITIONS

Supplementary Protection Certificates for EPIVIR-HBV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	1990024-0	Sweden		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 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	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
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
0513917	SPC/GB98/019	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318
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

EPIVIR-HBV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EPIVIR-HBV

Introduction to EPIVIR-HBV

EPIVIR-HBV, also known as lamivudine, is a nucleoside analogue used in the treatment of chronic hepatitis B virus (HBV) infection. It is indicated for patients with evidence of hepatitis B viral replication and active liver disease.

Current Market Position

EPIVIR-HBV has been a staple in the treatment of chronic hepatitis B for several years. However, its market position is evolving due to the emergence of newer, more effective antiviral therapies.

Competitive Landscape

The hepatitis B market is highly competitive, with several other antiviral drugs available, such as entecavir, tenofovir, and newer pipeline therapies. Companies like GlaxoSmithKline, Ionis Pharma, Ascletis Pharmaceuticals, and Vir Biotechnology are developing novel treatments that could potentially replace or complement existing therapies like EPIVIR-HBV[1][3][4].

Financial Performance and Market Size

Historical Market Size

The global hepatitis B market, which includes EPIVIR-HBV, has seen significant growth in recent years. In 2022, the chronic hepatitis B market size in the 7MM (the United States, EU-4, the United Kingdom, and Japan) and China was approximately USD 2.4 billion[1].

Revenue Contribution

While specific revenue figures for EPIVIR-HBV are not provided in the latest reports, it is known that the drug has been a significant contributor to the overall hepatitis B market. However, its share is expected to decline as newer therapies gain approval and market acceptance.

Growth Drivers and Challenges

Advancements in Antiviral Therapies

The introduction of new antiviral drugs with higher precision and fewer side effects is a major driver for the hepatitis B market. However, this also poses a challenge for EPIVIR-HBV, as these newer therapies may offer better outcomes and patient compliance[3][4].

Resistance and Side Effects

EPIVIR-HBV faces challenges related to the development of resistance, particularly the YMDD mutation, which can lead to treatment failure and increased liver enzyme levels. This has prompted the need for alternative or combination therapies to manage resistance[2].

Cost-Effectiveness and Economic Impact

Comparison with Other Therapies

Studies have compared the cost-effectiveness of EPIVIR-HBV with other antiviral drugs like entecavir. For instance, entecavir has been shown to offer greater suppression of viral replication but at a higher drug acquisition cost. Despite this, entecavir may provide long-term health and economic benefits by reducing the risk of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma[5].

Future Outlook and Market Projections

Market Growth Rate

The overall hepatitis B market is expected to grow, albeit at a moderate rate. Projections indicate that the market will reach USD 4.9 billion by 2034, with a CAGR of 3.83% from 2024 to 2034[3].

Impact of New Therapies

The emergence of new therapies, such as bepirovirsen (GSK3228836) and VIR-2218, is expected to significantly impact the market. These therapies may capture a substantial share of the market, potentially reducing the market share of EPIVIR-HBV[1].

Regional Dynamics

Major Markets

The United States, Germany, France, the United Kingdom, Italy, Spain, and Japan are key markets for hepatitis B treatments. The United States has the largest patient pool and represents the biggest market for hepatitis B treatment due to increasing prevalence and awareness[3][4].

Distribution Channels

Hospital and Retail Pharmacies

The hospital and retail pharmacies segment currently holds the largest revenue share in the hepatitis B market. This segment is expected to continue dominating due to the high number of patients seeking immediate diagnosis and treatment at hospitals[4].

Key Takeaways

• Market Competition: EPIVIR-HBV faces increasing competition from newer antiviral therapies.
• Resistance and Side Effects: The drug's effectiveness is challenged by the development of resistance and side effects.
• Cost-Effectiveness: Newer therapies like entecavir may offer better long-term health and economic outcomes despite higher costs.
• Future Outlook: The market is expected to grow moderately, but EPIVIR-HBV's share may decline with the introduction of new therapies.

FAQs

Q: What is EPIVIR-HBV used for? A: EPIVIR-HBV is used for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver disease.

Q: What are the major challenges faced by EPIVIR-HBV in the market? A: The major challenges include the development of resistance, particularly the YMDD mutation, and the emergence of newer antiviral therapies with better efficacy and fewer side effects.

Q: How does the cost-effectiveness of EPIVIR-HBV compare to other antiviral drugs? A: EPIVIR-HBV is generally less expensive than newer therapies like entecavir but may offer less effective long-term health outcomes due to resistance issues.

Q: What is the projected growth rate of the hepatitis B market? A: The hepatitis B market is expected to grow at a CAGR of 3.83% from 2024 to 2034.

Q: Which regions are the major markets for hepatitis B treatments? A: The United States, Germany, France, the United Kingdom, Italy, Spain, and Japan are key markets for hepatitis B treatments.

Cited Sources

1. GlobeNewswire: Chronic Hepatitis B Market to Observe Stunning Growth at a CAGR of 13.4% by 2032 | DelveInsight
2. FDA: EPIVIR-HBV Label
3. BioSpace: Hepatitis B Market Estimated to Reach USD 4.9 Billion by 2034
4. Precedence Research: Hepatitis B Market Size To Hit Around USD 6.65 Bn By 2034
5. PMC: Evaluation of the Cost-Effectiveness of Entecavir Versus Lamivudine