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. Two 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
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	1,254
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

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
Denmark	0933372
Japan	3736964
Denmark	1098898
Germany	69838903

Supplementary Protection Certificates for LEXIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	SPC/GB08/018	United Kingdom		PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
0933372	324	Finland
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712

Market Dynamics and Financial Trajectory for Lexiva (Fosamprenavir)

Last updated: December 30, 2025

Executive Summary

Lexiva (fosamprenavir) is an antiretroviral medication developed by GlaxoSmithKline (GSK) for the treatment of HIV-1 infection. Approved by the U.S. FDA in 2003, Lexiva holds a significant position in the complex landscape of HIV therapy. This analysis explores market dynamics and financial trajectories that influence Lexiva's commercial performance, considering factors such as competitive landscape, patent expiry implications, clinical positioning, regulatory shifts, and emerging market trends. Strategic insights reveal that while Lexiva retains niche prominence due to its efficacy and tolerability profile, evolving treatment standards and aggressive generic competition present formidable challenges to its sustained financial trajectory.

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What Are the Core Market Dynamics Influencing Lexiva?

1. Competitive Landscape: What Are Key Players and Alternative Therapies?

a. Major competitors and alternative drugs

Drug Name	Class	Approved Indications	Market Share (Approximate)	Key Strengths
Darunavir (Prezista)	Protease inhibitor	HIV-1, resistant strains	35-40%	High barrier to resistance, favorable tolerability
Atazanavir (Reyataz)	Protease inhibitor	HIV-1, once daily dosing	15-20%	Once-daily regimens, fewer lipid effects
Integrase inhibitors	INSTIs (e.g., Dolutegravir, Raltegravir)	HIV-1	45-50% (combined)	Higher efficacy, simpler regimens, resistance barriers

Implication: Lexiva's market share (~2-5%) diminishes as integrase inhibitors dominate due to their superior efficacy, tolerability, and dosing convenience.

b. Position within the therapy regimen

Lexiva was initially positioned as a second-line protease inhibitor. The evolution toward regimens centered on integrase strand transfer inhibitors (INSTIs) limits Lexiva's appeal as a first-line agent. Its role now predominantly involves salvage therapy or specific resistance cases.

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2. Patent Expiry and Generic Competition: When and How Do They Impact the Market?

Lexiva's active component, fosamprenavir, was granted patent protection until approximately 2020, with some extension considerations:

Patent Expiry	Status	Impact
Primary patent: 2020	Faced market entry of generics	Sharp decline in sales post-patent expiry
Secondary patents (formulations, methods)	Limited, with some expirations	Slight prolongation of exclusivity
Data exclusivity (US: 5 years)	Ended by 2008–2012	Reduced barriers to generic entry

Outcome: Post-2020, generic fosamprenavir became available, exerting downward pressure on Lexiva's pricing and sales volume.

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3. Clinical Positioning and Therapeutic Shifts: How Do They Influence Market Dynamics?

a. Evolving treatment guidelines

• 2016 NIH Guidelines: Emphasize INSTIs as preferred agents.
• Protease inhibitors (PIs): Recommended primarily for treatment-experienced or resistance cases.
• Lexiva's niche: Salvage therapy with a favorable safety profile when resistance to other PIs exists.

b. Tolerability and safety profile

• Reduced gastrointestinal side effects relative to earlier PIs.
• Less impact on lipid profiles than ritonavir-boosted regimens.
• Nevertheless, newer agents offer greater convenience, diminishing Lexiva’s relative appeal.

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4. Regulatory and Policy Shifts: How Do They Shape Market Trajectory?

a. Pricing and reimbursement policies

• Increased pressure to reduce drug prices, especially for older branded drugs.
• Favoring generics in public procurement and insurance formularies.

b. Global access initiatives

• Increased procurement of INSTI-based regimens globally.
• Limited inclusion of Lexiva in many low- and middle-income country (LMIC) formulations.

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5. Emerging Market Trends: What Is the Future Outlook?

Trend	Implication for Lexiva	Outlook
Growth of Generic HIV drugs	Intensifies price competition	Short to medium term: declining sales
Focus on Treatment Simplification	Favor single-pill, once-daily regimens	Reduces Lexiva’s appeal unless repositioned
Advances in Long-acting injectables	Changes administration routes	Potentially marginalizes oral regimens like Lexiva
Patent expirations & biosimilars	Further price erosion	Accelerates decline in revenue

Projection: Lexiva’s commercial viability is expected to diminish further post-2025, unless positioning shifts toward niche markets.

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Financial Trajectory of Lexiva

Historical Revenue and Market Share Trends

Year	Estimated Global Sales (USD millions)	Notes
2003	~$300	Launch years, modest growth due to limited competition
2010	~$250	Entry of newer PIs and INSTIs, slight decline
2015	~$150	Increased competition, beginning generic threats
2020	<$50	Patent expiry, aggressive generic entry, market shrinkage
2022	<$20	Largely phased out in developed markets, niche use persists

Factors Driving Revenue Trend:

• Patent loss: Sharp decline post-2020.
• Generic competition: Cost advantages cut into sales.
• Market shifts: Preference toward newer agents.

Forecast for the Next 5 Years

Year	Projected Sales (USD millions)	Assumptions
2023	<$10	Reserved for salvage therapy or formulary niches
2024	~$5	Marginal market, dependent on regional policies
2025	<$2	Near-total market exit, focus on legacy stock management

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Comparison with Key Competitors and Market Trends

Aspect	Lexiva	Darunavir (Prezista)	Dolutegravir (Tivicay)	Atazanavir (Reyataz)
Age of drug	Launched 2003	Launched 2006	Launched 2013	Launched 2003
Patent expiration	2020 (patent), 2012 (formulations)	2021	2028	2020
Main market focus	Salvage, resistance cases	First-line, resistance	First-line, high barrier resistance	First-line, once daily
Market share (2022)	<1%	~5-8%	~45-50% (combined INSTIs)	~8-10%
Pricing trend	Declining rapidly	Stable, now generic entry	Decreasing with generics	Decreasing post-patent

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Key Challenges and Opportunities

Challenge	Opportunity
Patent expiry and generic competition	Repositioning for niche or resistant cases
Transition toward INSTIs	Developing combination therapies involving Lexiva
Regulatory constraints on older drugs	Innovation in formulations or delivery systems

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Key Takeaways

• Lexiva's market presence has diminished significantly due to patent expiry and the ascendancy of INSTI-based regimens.
• The drug's niche application remains limited primarily to salvage therapy or cases with specific resistance profiles.
• Patent cliff and generic competition have led to a steep decline in revenue, with projections indicating near-market exit by 2025.
• The evolving landscape favors newer, more convenient, and highly effective therapies, reducing Lexiva's strategic value.
• Companies must explore repositioning or niche marketing strategies to optimize residual value.

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FAQs

1. Will Lexiva regain market share in the future?

No. Given the dominance of INSTIs and the availability of cheaper generics, Lexiva's resurgence is unlikely. Its role remains confined to specific resistance cases in salvage therapy.

2. How does the patent expiry impact Lexiva's profitability?

Patent expiry opened the market to generic fosamprenavir, drastically reducing prices and sales volume, leading to a substantial decline in revenue and profitability.

3. Are there any ongoing efforts to develop new formulations of Lexiva?

Currently, no significant efforts are underway, as the focus shifts toward newer agents with improved efficacy and safety profiles.

4. Which markets might still sustain Lexiva sales?

Limited to markets with delayed generic entry or specific formulary preferences, such as some low-income countries with limited access to newer agents.

5. What strategic moves can pharmaceutical companies pursue with drugs like Lexiva?

Options include orphan or niche indications, combination formulations, or repurposing within broader antiviral regimens—though these are increasingly challenging given current treatment paradigms.

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Sources

[1] U.S. Food and Drug Administration (FDA). “FDA Approvals for Fosamprenavir,” 2003.
[2] IMS Health Data, 2022. “Global HIV Market Shares and Revenue Estimates.”
[3] NIH Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents, 2016.
[4] MarketWatch, “HIV Drug Market Trends,” 2022.
[5] Patent and Exclusivity Data, US Patent Office, 2022.

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Disclaimer: This report is intended for informational purposes for business professionals and does not serve as investment or clinical guidance.