LEXIVA Drug Patent Profile

When do Lexiva patents expire, and when can generic versions of Lexiva launch?

Lexiva is a drug marketed by Viiv Hlthcare and is included in two NDAs.

The generic ingredient in LEXIVA is fosamprenavir calcium. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lexiva

A generic version of LEXIVA was approved as fosamprenavir calcium by MYLAN on April 15^th, 2016.

Summary for LEXIVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	12
Patent Applications:	427
Drug Prices:	Drug price information for LEXIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEXIVA
What excipients (inactive ingredients) are in LEXIVA?	LEXIVA excipients list
DailyMed Link:	LEXIVA at DailyMed

See drug prices for LEXIVA

Recent Clinical Trials for LEXIVA

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

Sponsor	Phase
Medical College of Wisconsin	Phase 3
GlaxoSmithKline	Phase 1
ViiV Healthcare	Phase 1

See all LEXIVA clinical trials

Pharmacology for LEXIVA

Drug Class	Protease Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors P-Glycoprotein Inducers

Paragraph IV (Patent) Challenges for LEXIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEXIVA	Tablets	fosamprenavir calcium	700 mg	021548	1	2012-01-18

US Patents and Regulatory Information for LEXIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	SUSPENSION;ORAL	022116-001	Jun 14, 2007		DISCN	Yes	No
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003		DISCN	Yes	No

Expired US Patents for LEXIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	SUSPENSION;ORAL	022116-001	Jun 14, 2007
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003

International Patents for LEXIVA

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	9815567
Austria	229964
New Zealand	505776	Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors

Supplementary Protection Certificates for LEXIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	300339	Netherlands		300339, 20180310, EXPIRES: 20190711
0933372	91426	Luxembourg		91426, EXPIRES: 20190712
0933372	SPC012/2008	Ireland		SPC012/2008: 20091119, EXPIRES: 20190711

LEXIVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LEXIVA

Introduction

LEXIVA, also known as fosamprenavir calcium, is a protease inhibitor used in the treatment of HIV infection. Developed by Vertex Pharmaceuticals and marketed by GlaxoSmithKline (GSK), LEXIVA has been a significant player in the HIV drugs market. Here, we will delve into the market dynamics and financial trajectory of LEXIVA.

Market Context of HIV Drugs

The global HIV drugs market is projected to grow significantly, driven by increasing demand, government initiatives, and rising cases of HIV. As of 2022, 39 million people globally were living with HIV, with 1.3 million new infections and 630,000 AIDS-related deaths reported[1].

LEXIVA's Position in the Market

LEXIVA is part of the broader class of protease inhibitors, which are crucial in the treatment of HIV. The drug's effectiveness is evident from clinical trials, where it has shown significant viral load reduction and CD4+ cell count increase in patients[4].

Clinical Efficacy

Studies such as APV30001 and APV30002 have demonstrated LEXIVA's efficacy when used in combination with other antiretroviral drugs. For instance, in the APV30001 study, LEXIVA plus ritonavir showed comparable results to nelfinavir in reducing viral loads and increasing CD4+ cell counts[4].

Financial Performance

Revenue Contribution

LEXIVA has contributed to GSK's revenue, particularly within the HIV segment. In 2014, ViiV Healthcare, a joint venture between GSK and other pharmaceutical companies, reported a 15% growth in sales, with products like Tivicay and Triumeq reaching £339 million. While specific figures for LEXIVA are not isolated, it is part of this growing segment[3].

Market Share and Distribution

The HIV drugs market is dominated by hospital pharmacies, but online pharmacies are expected to grow at the highest CAGR due to convenience and heavy discounts. LEXIVA, being a prescription drug, is primarily distributed through hospital pharmacies and retail pharmacies, with a growing presence in online channels[1].

Regional Performance

North America

North America, particularly the U.S., has been a key market for LEXIVA due to the robust healthcare infrastructure and high healthcare expenditure. GSK's strong presence in this region, along with other major players, has driven the sales of HIV drugs, including LEXIVA[1].

Emerging Markets

Asia-Pacific, with its large population base and increasing purchasing power, is expected to grow at the highest rate. While LEXIVA's specific performance in these markets is not detailed, GSK's overall strategy includes expanding in emerging markets, which could benefit LEXIVA's sales[1].

Competitive Landscape

The HIV drugs market is highly competitive, with several major players including AbbVie Inc., Bristol-Myers Squibb Company, Gilead Sciences, Inc., Johnson & Johnson, and Merck & Co., Inc. LEXIVA competes within this landscape, leveraging GSK's extensive distribution network and marketing capabilities[1].

Research and Development

GSK has a strong R&D pipeline, which includes several HIV drugs. The company's focus on innovation and its ability to launch new products, such as Tivicay and Triumeq, have been crucial in maintaining market share. LEXIVA benefits from being part of this innovative ecosystem, with ongoing research aimed at improving treatment options for HIV patients[3].

Financial Strategy and Cost Control

GSK's financial strategy involves maintaining an efficient balance sheet, investing in strategic priorities, and improving financial efficiencies. The company has delivered significant cost savings through restructuring initiatives, which helps in supporting the development and marketing of drugs like LEXIVA[3].

Key Takeaways

• Market Growth: The HIV drugs market, including LEXIVA, is expected to grow at a CAGR of 4.5% from 2023 to 2032.
• Clinical Efficacy: LEXIVA has shown significant efficacy in clinical trials, making it a valuable treatment option.
• Revenue Contribution: LEXIVA contributes to GSK's revenue within the HIV segment, although specific figures are not isolated.
• Regional Performance: North America is a key market, with emerging markets offering significant growth potential.
• Competitive Landscape: LEXIVA competes in a highly competitive market, leveraging GSK's strengths in distribution and marketing.

Future Outlook

The future outlook for LEXIVA is positive, driven by the growing demand for HIV drugs, advancements in treatment options, and GSK's strategic focus on innovation and cost control. As the global healthcare landscape evolves, LEXIVA is poised to remain a significant player in the HIV treatment market.

FAQs

What is LEXIVA used for?

LEXIVA, or fosamprenavir calcium, is used in the treatment of HIV infection. It is a protease inhibitor that helps reduce the viral load and increase CD4+ cell counts in patients.

Who markets LEXIVA?

LEXIVA is marketed by GlaxoSmithKline (GSK) in collaboration with Vertex Pharmaceuticals, which developed the drug.

How does LEXIVA perform in clinical trials?

LEXIVA has shown significant efficacy in clinical trials, demonstrating comparable results to other protease inhibitors like nelfinavir in reducing viral loads and increasing CD4+ cell counts.

What is the market outlook for LEXIVA?

The market outlook for LEXIVA is positive, with the global HIV drugs market expected to grow at a CAGR of 4.5% from 2023 to 2032. North America and emerging markets are key regions for growth.

How does GSK support the development and marketing of LEXIVA?

GSK supports the development and marketing of LEXIVA through its strong R&D pipeline, efficient financial strategies, and extensive distribution network.

Sources

1. Allied Market Research - HIV Drugs Market Size, Share and Growth Analysis | Report, 2032
2. GSK Annual Report 2008 - [PDF] GSK Annual Report 2008
3. GSK Strategic Report 2014 - [PDF] Strategic Report 2014 - GSK
4. FDA Label for LEXIVA - [PDF] LEXIVA™ - accessdata.fda.gov
5. Vertex Pharmaceuticals - [PDF] 8000000 Shares VERTEX PHARMACEUTICALS INCORPORATED