CRIXIVAN Drug Patent Profile

When do Crixivan patents expire, and what generic alternatives are available?

Crixivan is a drug marketed by Merck Sharp Dohme and is included in one NDA.

The generic ingredient in CRIXIVAN is indinavir sulfate. There are two drug master file entries for this compound. Additional details are available on the indinavir sulfate profile page.

Summary for CRIXIVAN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	11
Patent Applications:	5,101
Drug Prices:	Drug price information for CRIXIVAN
What excipients (inactive ingredients) are in CRIXIVAN?	CRIXIVAN excipients list
DailyMed Link:	CRIXIVAN at DailyMed

See drug prices for CRIXIVAN

Recent Clinical Trials for CRIXIVAN

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

Sponsor	Phase
Oncology Institute of Southern Switzerland	Phase 2
Emory University	Phase 4
National Institutes of Health Clinical Center (CC)	Phase 1

See all CRIXIVAN clinical trials

US Patents and Regulatory Information for CRIXIVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-001	Mar 13, 1996		DISCN	Yes	No
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	Mar 13, 1996		DISCN	Yes	No
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-005	Dec 17, 1998		DISCN	No	No
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-006	Apr 19, 2000		DISCN	No	No

Expired US Patents for CRIXIVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-006	Apr 19, 2000
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-001	Mar 13, 1996
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-005	Dec 17, 1998
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-006	Apr 19, 2000
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	Mar 13, 1996
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-001	Mar 13, 1996
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	Mar 13, 1996

International Patents for CRIXIVAN

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

Country	Patent Number	Title	Estimated Expiration
Canada	2161334
Canada	2211973
European Patent Office	0806957	THERAPIE D'ASSOCIATION POUR L'INFECTION A VIH A L'AIDE DE L'INHIBITEUR INDINAVIR DE LA PROTEASE DE VIH, DE L'INHIBITEUR 3TC DE LA TRANSCRIPTASE INVERSE EN ASSOCIATION AVEC L'AZT. (COMBINATION THERAPY FOR HIV INFECTION USING THE HIV PROTEASE INHIBITOR INDINAVIR ADN THE REVERSE TRANSCRIPTASE INHIBITOR 3TC TOGETHER WITH AZT.)
Hong Kong	1006060
Norway	941696
Portugal	806957
Singapore	64366	Hiv protease inhibitors useful for the treatment of aids

Market Dynamics and Financial Trajectory of Crixivan

Introduction

Crixivan, a protease inhibitor developed by Merck & Co., Inc., was a groundbreaking drug in the treatment of HIV/AIDS. Its development and market performance are insightful for understanding the complexities of the pharmaceutical industry, particularly in the context of innovative treatments for critical diseases.

Development and Approval

Crixivan was the result of Merck's most aggressive research program ever, reflecting the company's commitment to innovation in the pharmaceutical industry. Approved in a record 42 days by the FDA, Crixivan quickly became a crucial component in the treatment regimen for HIV/AIDS patients worldwide[1].

Market Impact

The introduction of Crixivan had a significant impact on the management of HIV/AIDS. By 1997, it contributed to the first decline in AIDS deaths in the history of the epidemic. This drug reached nearly 200,000 people worldwide, demonstrating its widespread adoption and effectiveness[1].

Pricing and Accessibility

Initially, Crixivan had an astronomical price tag, which was a common challenge for many innovative pharmaceuticals. However, the introduction of generic alternatives, such as Inhibisam in Argentina, forced Merck to reduce the price of Crixivan in several developing countries. Inhibisam, a generic version of indinavir, was priced approximately half that of Crixivan when first introduced and eventually cost about 15% less than Crixivan in Argentina[4].

Financial Trajectory

The financial trajectory of Crixivan was influenced by several factors, including its high development costs and the need for pharmaceutical companies to recoup their investments. Merck invested heavily in the development of Crixivan, with the average cost to bring a compound to market estimated at $400 million over 10 to 15 years of clinical trials and regulatory reviews[1].

Revenue and Sales

Despite the high costs, Crixivan generated significant revenue for Merck. The drug's success was part of a broader trend where innovative treatments for chronic and life-threatening conditions could achieve substantial sales. However, the revenue was also subject to market dynamics, including competition from generics and changes in government policies and healthcare expenditure[1].

Government Expenditure and Pricing Pressures

Government expenditure on HIV medications, including Crixivan, has been a critical factor in its financial trajectory. In many countries, government policies and pricing controls can significantly impact the revenue of pharmaceutical companies. For instance, the need for rapid FDA approvals and the protection of patents were emphasized by Merck's CEO, Raymond V. Gilmartin, as essential for maintaining innovation and profitability in the industry[1].

Market Competition and Generic Alternatives

The introduction of generic alternatives like Inhibisam in Argentina marked a significant shift in the market dynamics for Crixivan. Generic drugs can dramatically reduce the cost of treatment, making it more accessible but also reducing the revenue for the original drug. This competition forced Merck to adjust its pricing strategy, particularly in developing countries[4].

Global Market Trends

The success of Crixivan and other innovative drugs is heavily dependent on developed markets. According to IQVIA, 86% of the first five years' sales of new chemical entities (NCEs) come from developed markets like the US, Japan, Germany, France, Italy, Spain, and the UK. This concentration of sales in a few markets can concentrate risk but also highlights the importance of these markets for the financial success of new drugs[3].

Impact of Regulatory and Policy Changes

Regulatory and policy changes can significantly impact the financial trajectory of drugs like Crixivan. Speedy FDA approvals, protection of patents, and support for basic biomedical research are crucial for maintaining innovation and profitability. However, changes in healthcare policies and pricing controls can affect the revenue and profitability of pharmaceutical companies[1].

Conclusion on Market Dynamics

The market dynamics and financial trajectory of Crixivan illustrate the complex interplay between innovation, pricing, accessibility, and regulatory policies in the pharmaceutical industry. The success of such drugs depends on a balance between recouping significant development costs and ensuring accessibility to patients, particularly in the context of life-threatening diseases like HIV/AIDS.

Key Takeaways

• Innovation and Development Costs: Crixivan's development was part of Merck's most aggressive research program, highlighting the significant costs involved in bringing innovative treatments to market.
• Market Impact: Crixivan contributed to the first decline in AIDS deaths in 1997, demonstrating its clinical effectiveness.
• Pricing and Accessibility: The drug's high initial price was later reduced due to competition from generics and market pressures.
• Financial Trajectory: The revenue from Crixivan was influenced by its high development costs, market competition, and regulatory policies.
• Global Market Trends: The success of Crixivan and similar drugs is heavily dependent on developed markets.
• Regulatory and Policy Changes: Speedy FDA approvals and patent protection are crucial for the financial success of innovative drugs.

FAQs

What was the impact of Crixivan on the treatment of HIV/AIDS?

Crixivan was a groundbreaking drug that contributed to the first decline in AIDS deaths in 1997, reaching nearly 200,000 people worldwide and significantly improving the management of HIV/AIDS.

How did the introduction of generic alternatives affect Crixivan?

The introduction of generic alternatives like Inhibisam in Argentina reduced the price of Crixivan, making it more accessible but also reducing Merck's revenue from the drug.

What are the key factors influencing the financial trajectory of Crixivan?

The financial trajectory of Crixivan was influenced by its high development costs, market competition, regulatory policies, and government expenditure on HIV medications.

Why are developed markets crucial for the success of drugs like Crixivan?

Developed markets account for 86% of the first five years' sales of new chemical entities, making them critical for the financial success of innovative drugs like Crixivan.

How do regulatory and policy changes affect the financial success of pharmaceutical companies?

Regulatory and policy changes, such as speedy FDA approvals and patent protection, are essential for maintaining innovation and profitability in the pharmaceutical industry.

Sources

1. MIT News: "Merck CEO tells story of AIDS drug | MIT News"
2. PBS: "Human Immunodeficiency Virus (HIV) - PBS"
3. IQVIA: "Launch Excellence V - IQVIA"
4. Aidsmap: "Argentinian generic indinavir compares well with Crixivan - Aidsmap"