FOSAMPRENAVIR CALCIUM - Generic Drug Details

What are the generic sources for fosamprenavir calcium and what is the scope of patent protection?

Fosamprenavir calcium is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Mylan, and Sun Pharm, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for fosamprenavir calcium. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for FOSAMPRENAVIR CALCIUM

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOSAMPRENAVIR CALCIUM
What excipients (inactive ingredients) are in FOSAMPRENAVIR CALCIUM?	FOSAMPRENAVIR CALCIUM excipients list
DailyMed Link:	FOSAMPRENAVIR CALCIUM at DailyMed

Recent Clinical Trials for FOSAMPRENAVIR CALCIUM

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2/Phase 3

See all FOSAMPRENAVIR CALCIUM clinical trials

Generic filers with tentative approvals for FOSAMPRENAVIR CALCIUM

Applicant	Application No.	Strength	Dosage Form
		700MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FOSAMPRENAVIR CALCIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for FOSAMPRENAVIR CALCIUM

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for FOSAMPRENAVIR CALCIUM

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 FOSAMPRENAVIR CALCIUM

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	TABLET;ORAL	021548-001	Oct 20, 2003		DISCN	Yes	No
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	SUSPENSION;ORAL	022116-001	Jun 14, 2007		DISCN	Yes	No
Sun Pharm	FOSAMPRENAVIR CALCIUM	fosamprenavir calcium	TABLET;ORAL	204024-001	Nov 20, 2019	AB	RX	No	No

Expired US Patents for FOSAMPRENAVIR CALCIUM

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

Market Dynamics and Financial Trajectory for Fosamprenavir Calcium

Last updated: July 27, 2025

Introduction

Fosamprenavir calcium, an antiretroviral prodrug of amprenavir, has played a pivotal role in the management of HIV/AIDS since its approval. Market dynamics surrounding this pharmaceutical compound are influenced by a complex interplay of clinical efficacy, regulatory landscapes, competitive environment, and evolving global healthcare needs. This analysis delves into the factors shaping Fosamprenavir calcium’s market trajectory, assesses its current financial outlook, and explores future growth opportunities within the broader context of antiretroviral therapies.

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Pharmacological Profile and Clinical Significance

Fosamprenavir calcium is a prodrug designed to improve pharmacokinetics and bioavailability of amprenavir—a protease inhibitor (PI). It is administered orally and used in combination therapies to suppress HIV replication. Its efficacy in reducing viral load and delaying disease progression has firmly established its utility in antiretroviral regimens, especially prior to the advent of newer agents with better resistance profiles.

Despite its clinical benefits, Fosamprenavir’s market penetration has historically been influenced by the emergence of newer drugs, such as integrase strand transfer inhibitors (INSTIs) and fixed-dose combination therapies that offer simplified regimens, improved tolerability, and fewer drug interactions.

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Market Dynamics

1. Competitive Landscape and Drug Pipeline

The landscape for HIV treatment has shifted considerably, with several newer agents surpassing Fosamprenavir calcium in efficacy, safety, and convenience. The dominance of drugs like Dolutegravir (DTG) and Bictegravir (BIC), which are available in fixed-dose combinations, has led to the decline in Fosamprenavir’s prescribing rates.

However, Fosamprenavir retains niche utility, particularly in patients with resistance to other PIs or intolerances to newer agents. Its position in therapeutic regimens is also influenced by the availability of generics, which significantly reduces treatment costs and enhances access in resource-limited settings.

2. Patent Expires and Generic Competition

Patent expirations for Fosamprenavir have opened pathways for generic manufacturers, dramatically impacting market prices and sales volume. Generic versions have increased accessibility in low- and middle-income countries, bolstering its use in global HIV programs driven by organizations such as WHO and the Global Fund.

The entry of cost-effective generics has intensified price competition, leading to margin compression for branded formulations and influencing the strategic focus of pharmaceutical companies. The shift toward generics has been pivotal in expanding treatment coverage but challenges the profitability of branded Fosamprenavir formulations.

3. Regulatory Environment

Regulatory agencies such as the FDA, EMA, and WHO maintain rigorous standards for approval, quality, and safety. While Fosamprenavir remains approved in various regions, some approvals have been withdrawn or restricted based on evolving safety profiles or advances in treatment guidelines.

Regulatory support for expanding indications or new formulations remains limited, given the drug’s phase-out in favor of newer agents. Conversely, approvals for generic formulations facilitate market entry but also entail compliance costs.

4. Global Healthcare Trends

The global HIV/AIDS burden continues predominantly in sub-Saharan Africa and parts of Asia, where affordable generic drugs are essential. Initiatives such as PEPFAR and the Global Fund have facilitated widespread access to antiretrovirals, including Fosamprenavir generics. However, in high-income countries, the focus has shifted toward drugs with simplified dosing and improved tolerability, diminishing Fosamprenavir’s market share.

5. Clinical and Economic Shifts

The continuous evolution of HIV treatment guidelines favor integrase inhibitors due to their potency, tolerability, and minimal resistance issues. Consequently, Fosamprenavir’s role has diminished in developed markets but persists as a secondary or salvage therapy option.

Economically, the decline in branded sales coupled with the rapid proliferation of generics has reduced revenue streams for manufacturers. However, the global demand in resource-constrained regions sustains a baseline level of sales, especially through licensed generics.

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Financial Trajectory Analysis

1. Historical Revenue Trends

Historically, Fosamprenavir generated significant revenues during its patent-protected phase, driven by sales in North America, Europe, and select emerging markets. Post-patent expiry, revenues have declined sharply, reflecting increased generic competition and reduced prescribing in developed regions.

2. Current Market Performance

The current financial outlook indicates a stabilized, yet downward-trending revenue profile. For example, in the United States and Europe, sales have dwindled to niche markets, primarily in salvage therapy cases. The primary revenue contributor now shifts to emerging markets where generics are dominant.

3. Key Revenue Sources and Cost Dynamics

• Revenue: Largely derived from licensing agreements for generic formulations and residual branded sales.
• Cost of Goods Sold (COGS): Reduced due to generic manufacturing efficiencies.
• Research & Development (R&D): Minimal allocation, given the drug’s age and limited pipeline prospects.
• Regulatory & Marketing: Low to negligible, aligned with its mature status.

4. Future Market Projection

The future financial prospects for Fosamprenavir calcium hinge on several factors:

• Global HIV Treatment Trends: As the industry shifts towards newer agents, Fosamprenavir’s role will diminish unless significant new indications or formulations emerge.
• Generic Market Expansion: Continued growth in low-income settings will sustain baseline revenues.
• Potential New Formulations: Opportunities are limited; however, formulations promising improved tolerability could temporarily bolster usage.
• Strategic Collaborations: Licensing or co-marketing agreements could optimize returns in targeted markets.

Overall, the trajectory suggests a gradual decline in revenue, stabilizing at lower levels dictated by generic demand in resource-limited settings.

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Strategic Implications for Stakeholders

Manufacturers should reassess investment strategies, focusing on niche applications, developing combination therapies, or pivoting toward newer antiretrovirals. Policymakers and healthcare providers should prioritize access to generics to maximize treatment coverage, especially in underserved regions.

Investors evaluating Fosamprenavir calcium should consider the implications of patent expiries, competitive dynamics, and the shifting landscape favoring novel agents. Market opportunities mainly exist in supporting therapies, generic supply chains, and global HIV/AIDS mitigation programs.

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Key Takeaways

• Fosamprenavir calcium’s market share has declined in developed markets due to the advent of newer, more manageable antiretrovirals, notably integrase inhibitors.
• Patent expirations and the proliferation of generic formulations have expanded access in resource-limited settings, reducing manufacturing costs and maintaining a baseline revenue stream.
• The drug’s future financial trajectory will trend downward, with revenues primarily sustained by generic consumption in emerging economies.
• Strategic focus for stakeholders should include niche applications, cost-effective generic manufacturing, and potential specialized formulations to extend market relevance.
• The evolving landscape underscores the importance of continuous innovation for maintaining competitiveness and addressing unmet needs within HIV treatment paradigms.

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FAQs

1. Why has Fosamprenavir calcium declined in prominence within HIV treatment regimens?
Its decline stems from the availability of newer drugs with better tolerability, simplified dosing, and lower resistance profiles, such as integrase inhibitors. The emergence of these agents has shifted prescribing practices away from Fosamprenavir.

2. What impact has patent expiry had on Fosamprenavir’s market?
Patent expiry facilitated the entry of generic competitors, drastically reducing prices, expanding access in developing countries, and leading to a decline in branded sales and revenue in developed markets.

3. Are there future opportunities for Fosamprenavir calcium in HIV therapy?
Limited, unless new formulations or indications enhance its appeal. Its role is expected to remain niche, primarily driven by generic supply and salvage therapy needs.

4. How do global health initiatives influence Fosamprenavir’s market?
Programs like PEPFAR and the Global Fund promote generic drug use in low-income countries, sustaining demand for Fosamprenavir generics and increasing treatment coverage where cost is a key barrier.

5. What strategic considerations should pharmaceutical companies adopt regarding Fosamprenavir?
Focus on niche markets, optimize generic manufacturing, and explore combination therapies or formulations that improve patient compliance, acknowledging its declining role in the face of newer agents.

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References

[1] US Food and Drug Administration. Fosamprenavir calcium product labeling.
[2] World Health Organization. Antiretroviral drugs for treating HIV infection. 2022.
[3] IQVIA. Global HIV/AIDS drug market analysis, 2021.
[4] Global Fund. Procurement guidelines for antiretroviral medicines, 2023.
[5] MarketWatch. HIV antiretroviral drug market trends and forecasts, 2022.