EPZICOM Drug Patent Profile

Which patents cover Epzicom, and what generic alternatives are available?

Epzicom is a drug marketed by Viiv Hlthcare and is included in one NDA.

The generic ingredient in EPZICOM is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epzicom

A generic version of EPZICOM was approved as abacavir sulfate; lamivudine by CHARTWELL RX on March 28^th, 2017.

Summary for EPZICOM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	21
Patent Applications:	2,329
Drug Prices:	Drug price information for EPZICOM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPZICOM
What excipients (inactive ingredients) are in EPZICOM?	EPZICOM excipients list
DailyMed Link:	EPZICOM at DailyMed

See drug prices for EPZICOM

Recent Clinical Trials for EPZICOM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3
AIDS Clinical Trials Group	Phase 3
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3

See all EPZICOM clinical trials

Pharmacology for EPZICOM

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for EPZICOM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPZICOM	Tablets	abacavir sulfate; lamivudine	600 mg/300 mg	021652	1	2007-09-27

US Patents and Regulatory Information for EPZICOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004		DISCN	Yes	No

Expired US Patents for EPZICOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004

International Patents for EPZICOM

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

Country	Patent Number	Title	Estimated Expiration
Japan	2875814
Denmark	0817637
Canada	2289753	HEMISULFATE DE NUCLEOSIDE CARBOCYCLIQUE ET UTILISATION CONNEXE POUR TRAITER DES INFECTIONS VIRALES (CARBOCYCLIC NUCLEOSIDE HEMISULFATE AND ITS USE IN TREATING VIRAL INFECTIONS)
China	1326743

Supplementary Protection Certificates for EPZICOM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	SPC/GB05/027	United Kingdom		SPC/GB05/027: 20050922, EXPIRES: 20191216
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
0817637	91171	Luxembourg		91171, EXPIRES: 20191217
0434450	1999C0033	Belgium		PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628

EPZICOM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Epzicom

Introduction

Epzicom, a dual NRTI (nucleoside reverse transcriptase inhibitor) combination pill, was approved in the U.S. in August 2004 by GlaxoSmithKline (GSK). This drug has been a significant player in the HIV treatment market, although its market dynamics and financial trajectory have evolved over the years.

Approval and Initial Market Impact

Epzicom, which combines abacavir and lamivudine, was one of the first dual NRTI combination pills to be approved, along with Gilead's Truvada. These approvals marked a significant advancement in HIV treatment, offering patients a more convenient and potentially more effective treatment option compared to multiple pills[1].

Market Competition

Since its approval, Epzicom has faced intense competition in the HIV market. The market is dominated by several key players, including Gilead Sciences, which has been particularly successful with its own combination therapies like Truvada and later Biktarvy. Biktarvy, for instance, has seen remarkable success and is forecasted to achieve significant sales, potentially reaching $7.674 billion by 2024[1].

Sales Performance

While Epzicom has contributed to GSK's revenue, its sales have not matched the levels of some of its competitors. GSK's overall pharmaceutical sales have been influenced by various factors, including the performance of other therapeutic areas such as respiratory and oncology. In 2013, for example, GSK reported a broadly-based sales performance, but the specific sales figures for Epzicom were not highlighted as a major contributor to this growth[3].

Regional Market Dynamics

The HIV drugs market is geographically diverse, with North America being a major market due to the presence of robust healthcare infrastructure and high healthcare expenditure. However, Epzicom's market share in this region has been challenged by other drugs, particularly those from Gilead Sciences. The Asia-Pacific region, with its large population and increasing healthcare expenditure, is also a significant market, but Epzicom's presence here has been less prominent compared to other regions[4].

Distribution Channels

The distribution of HIV drugs, including Epzicom, is primarily through hospital pharmacies, which dominated the market in 2022. However, online pharmacies are expected to witness the highest growth rate during the forecast period due to convenience, improvements in logistics, and ease of payment options. This shift could impact the sales dynamics of Epzicom and other HIV drugs[4].

Financial Performance of GSK

GSK's financial performance has been influenced by its overall portfolio of drugs, including Epzicom. In 2013, GSK reported a turnover of £26.5 billion, with core earnings per share up 4% to 112.2p. While Epzicom contributed to these figures, it was not a standout performer compared to other therapeutic areas. GSK has continued to focus on restructuring and simplifying its business to reduce costs and invest in growth markets and new product launches[3].

Future Outlook

The global HIV drugs market is expected to grow at a CAGR of 4.5% from 2023 to 2032, reaching $51.1 billion by 2032. However, Epzicom's share in this growing market is likely to be overshadowed by newer and more advanced therapies. The rise in cases of HIV, increased awareness and diagnosis, and advancements in HIV drugs will drive the demand, but Epzicom may not be at the forefront of this growth due to the dominance of other drugs[4].

Key Takeaways

• Market Competition: Epzicom faces significant competition from other HIV combination therapies, particularly from Gilead Sciences.
• Regional Dynamics: North America is a major market, but Epzicom's presence is less prominent here compared to other regions.
• Distribution Channels: Hospital pharmacies dominate, but online pharmacies are expected to grow significantly.
• Financial Performance: Epzicom contributes to GSK's revenue but is not a standout performer.
• Future Outlook: The HIV drugs market is growing, but Epzicom's share is likely to be overshadowed by newer therapies.

FAQs

1. What is Epzicom and when was it approved? Epzicom is a dual NRTI combination pill containing abacavir and lamivudine, approved in the U.S. in August 2004.

2. How does Epzicom compare to other HIV drugs in the market? Epzicom faces significant competition from other HIV combination therapies, particularly from Gilead Sciences' drugs like Truvada and Biktarvy.

3. What are the key distribution channels for HIV drugs like Epzicom? Hospital pharmacies currently dominate the market, but online pharmacies are expected to witness the highest growth rate due to convenience and logistical improvements.

4. How has GSK's financial performance been influenced by Epzicom? Epzicom contributes to GSK's revenue, but it is not a standout performer compared to other therapeutic areas.

5. What is the future outlook for the HIV drugs market and Epzicom's place in it? The HIV drugs market is expected to grow, but Epzicom's share is likely to be overshadowed by newer and more advanced therapies.

Sources

1. Clarivate: Biktarvy, the booming blockbuster, drives HIV market | Clarivate
2. PR Newswire: Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results and Provides 2024 Financial Guidance
3. GSK: Annual Report 2013 | GSK
4. Allied Market Research: HIV Drugs Market Size, Share and Growth Analysis | Report, 2032