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. Three 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:	3
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	2
Patent Applications:	782
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	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
Sun Pharm	FOSAMPRENAVIR CALCIUM	fosamprenavir calcium	TABLET;ORAL	204024-001	Nov 20, 2019	AB	RX	No	No
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003		DISCN	Yes	No
Mylan	FOSAMPRENAVIR CALCIUM	fosamprenavir calcium	TABLET;ORAL	204060-001	Apr 15, 2016	AB	RX	No	Yes
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	SUSPENSION;ORAL	022116-001	Jun 14, 2007		DISCN	Yes	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

FOSAMPRENAVIR CALCIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fosamprenavir Calcium

Introduction

Fosamprenavir calcium, marketed under the brand name LEXIVA, is a prodrug of amprenavir, an HIV protease inhibitor used in the treatment of HIV-1 infection. To understand the market dynamics and financial trajectory of this drug, it is essential to delve into its clinical use, market performance, and the broader pharmaceutical landscape.

Clinical Use and Efficacy

Fosamprenavir calcium is indicated for the treatment of HIV infection in adults, often used in combination with other antiretroviral medications. It is rapidly converted to amprenavir by cellular phosphatases, which then inhibits the HIV-1 protease, preventing the processing of viral Gag and Gag-Pol polyprotein precursors[1][2][5].

Comparative Studies

Studies have shown that regimens using LEXIVA plus ritonavir are comparable in efficacy and tolerability to other protease inhibitors like Kaletra (lopinavir/ritonavir). A head-to-head study published in The Lancet demonstrated that LEXIVA/r and lopinavir/r had similar outcomes in terms of viral load suppression and CD4 cell count increases[4].

Market Performance

Launch and Initial Reception

LEXIVA was introduced to the market by GlaxoSmithKline (GSK), and its launch was part of GSK's broader strategy to expand its antiretroviral portfolio. The drug's performance was closely watched, especially given the competitive landscape of HIV treatments.

Sales and Revenue

In the early years following its launch, LEXIVA contributed to GSK's pharmaceutical sales, although the overall impact was moderate compared to other blockbuster drugs. For instance, in 2008, GSK's pharmaceutical turnover declined by 3% in constant exchange rate terms, partly due to generic competition and lower sales of certain patented products. However, the company's sales in emerging markets and vaccines showed significant growth, which somewhat offset the decline in other areas[3].

Financial Trajectory

Revenue Contribution

LEXIVA, as part of GSK's antiretroviral portfolio, contributed to the company's revenue stream. However, its financial impact was not as substantial as some of GSK's other products. The company's overall revenue in 2008 was £24.4 billion, with pharmaceutical sales excluding genericized products growing by 10% in constant exchange rate terms[3].

Cost and Pricing

The pricing of LEXIVA was competitive within the HIV treatment market. The cost-effectiveness of the drug, especially when used in combination with ritonavir, was a key factor in its market positioning. However, the pricing strategy had to balance between ensuring accessibility to patients and maintaining profitability for the company.

Generic Competition

As with many pharmaceutical products, the expiration of patents and the introduction of generic versions posed a significant threat to LEXIVA's market share. Generic versions of fosamprenavir calcium were approved and marketed by companies such as Mylan Pharmaceuticals and Sun Pharmaceutical Industries, which likely impacted the sales and revenue of the branded version[5].

Market Dynamics

Competitive Landscape

The HIV treatment market is highly competitive, with multiple protease inhibitors and other antiretroviral drugs available. LEXIVA had to compete with established brands like Kaletra and newer entrants in the market. The competitive landscape influenced pricing, marketing strategies, and the overall market share of LEXIVA.

Regulatory Environment

Regulatory approvals and guidelines played a crucial role in the market dynamics of LEXIVA. The drug's approval by regulatory bodies such as the FDA was critical for its market entry. Additionally, guidelines from health organizations on the use of antiretroviral therapies affected the prescribing patterns and market demand for LEXIVA[1][2].

Patient and Prescriber Preferences

Patient and prescriber preferences, including factors such as efficacy, tolerability, and convenience of dosing, influenced the market dynamics. LEXIVA's once-daily dosing option, when combined with ritonavir, was a significant selling point, enhancing patient compliance and preference[4].

Challenges and Opportunities

Generic Competition and Patent Expiration

The expiration of patents for LEXIVA and the subsequent entry of generic versions presented significant challenges to maintaining market share and revenue. However, this also created opportunities for GSK to focus on other strategic priorities and invest in new product development.

Emerging Markets

GSK's strategy to expand sales in emerging markets provided an opportunity for LEXIVA to reach a broader patient population. The growth in these markets helped offset declines in other regions and contributed to the overall financial trajectory of the drug[3].

Key Takeaways

• Clinical Efficacy: LEXIVA demonstrated comparable efficacy to other protease inhibitors in clinical studies.
• Market Performance: The drug contributed to GSK's pharmaceutical sales but faced challenges from generic competition and a competitive market.
• Financial Trajectory: Revenue from LEXIVA was part of GSK's broader pharmaceutical sales, which showed mixed performance due to various market and competitive factors.
• Market Dynamics: The competitive landscape, regulatory environment, and patient preferences significantly influenced the market dynamics of LEXIVA.
• Challenges and Opportunities: Generic competition posed a challenge, while emerging markets provided growth opportunities.

FAQs

What is fosamprenavir calcium used for?

Fosamprenavir calcium, marketed as LEXIVA, is used for the treatment of HIV-1 infection in adults, often in combination with other antiretroviral medications.

How does fosamprenavir calcium work?

Fosamprenavir calcium is rapidly converted to amprenavir by cellular phosphatases, which then inhibits the HIV-1 protease, preventing the processing of viral Gag and Gag-Pol polyprotein precursors.

What are the common dosing regimens for LEXIVA?

LEXIVA can be administered in various regimens, including 700 mg twice daily or 1,400 mg once daily, often in combination with ritonavir.

How does LEXIVA compare to other HIV protease inhibitors?

Studies have shown that LEXIVA plus ritonavir is comparable in efficacy and tolerability to other protease inhibitors like Kaletra.

What impact did generic competition have on LEXIVA's market share?

The introduction of generic versions of fosamprenavir calcium significantly impacted the market share and revenue of the branded version, as generic drugs are generally more affordable and can capture a substantial portion of the market.

Cited Sources

1. FDA Label: LEXIVA™ (fosamprenavir calcium) Tablets - [Access Data FDA][1]
2. FDA Label: LEXIVA - accessdata.fda.gov - [Access Data FDA][2]
3. GSK Annual Report 2008 - [GSK][3]
4. Head-to-Head Study Comparing LEXIVA(R) (fosamprenavir calcium) to Kaletra - [Vertex Pharmaceuticals][4]
5. Fosamprenavir: Uses, Interactions, Mechanism of Action - DrugBank - [DrugBank][5]