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:	59
Clinical Trials:	11
Patent Applications:	4,606
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	020685-006	Apr 19, 2000		DISCN	No	No
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

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	020685-001	Mar 13, 1996
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	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	020685-005	Dec 17, 1998
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
Hungary	9502860
Croatia	P940286
Poland	182742
Australia	711176
South Africa	9208563
Yugoslavia	15994
Bulgaria	98745

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CRIXIVAN

Last updated: July 27, 2025

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Introduction

CRIXIVAN (indinavir sulfate) is an antiretroviral medication historically pivotal in the management of HIV/AIDS. Developed by Merck & Co., it marked a major milestone as one of the first protease inhibitors approved for clinical use in 1996. The drug's market dynamics and financial trajectory reflect broader trends in HIV treatment, patent landscapes, and evolving therapeutic innovations.

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Market Evolution and Historical Significance

CRIXIVAN’s entry into the market coincided with a transformative period in HIV therapy, introducing protease inhibitors as a cornerstone of highly active antiretroviral therapy (HAART). Its initial success was driven by its efficacy in reducing viral loads and improving patient outcomes, which significantly increased demand and revenue for Merck.

However, the market landscape rapidly evolved due to the advent of newer antiretrovirals with enhanced tolerability, simplified dosing, and resistance profiles. Consequently, CRIXIVAN transitioned from a frontline most-prescribed agent to a secondary or backup option within combination regimens. Regulatory agencies globally, including FDA and EMA, confirmed its positioning as a treatment option, although its market share dwindled with innovation.

Patent Expiry and Generic Competition

The expiration of CRIXIVAN’s primary patent in 2010 marked a pivotal point in its financial trajectory. Patent cliffs historically precipitate substantial revenue declines owing to the entry of generic competitors. Following patent expiry, generic versions flooded markets primarily in North America, Europe, and emerging economies, significantly reducing prices.

Merck, the patent owner, responded by licensing and forming strategic alliances for generic manufacturing, which prolonged availability and stabilized revenues in specific markets, especially in regions with limited generic access initially. Nonetheless, the surge in generic competition led to an estimated 80-90% decline in price, dramatically impacting profit margins.

Market Size and Current Position

Despite declining revenues from its original indication, CRIXIVAN remains relevant within certain contexts:

• Niche Use Cases: In specific treatment regimens, particularly in resource-limited settings, generic formulations provide affordable options.
• Drug Resistance Management: For patients with resistance to more recent protease inhibitors, CRIXIVAN occasionally retains clinical relevance.
• Treatment of HIV in Developing Countries: WHO guidelines incorporate older protease inhibitors like indinavir where newer drugs are unavailable or infeasible.

The global HIV market is worth approximately $25 billion as of 2023, with growth driven by increasing global HIV prevalence, improved diagnosis, and expanded access to treatment. CRIXIVAN’s contribution has diminished but persists as part of the broader pharmacologic landscape.

Financial Trajectory Analysis

Revenue Trends

Since patent expiration, revenue generated specifically from CRIXIVAN has declined sharply, paralleling generic market entry. Merck’s annual sales for the drug dropped from peak levels exceeding $250 million in the late 2000s to below $50 million post-2015. The decline reflects market share erosion, pricing discounts, and geographic limitations on generic penetration.

Research and Development (R&D) Investment

Despite dwindling direct revenues, Merck continues investment in HIV treatment R&D, focusing on novel mechanisms like integrase inhibitors and long-acting formulations. These innovations aim to replace or improve upon older drugs like CRIXIVAN, thus phasing out traditional protease inhibitor sales altogether.

Regulatory and Legal Considerations

Patent challenges and patent linkage disputes have been prevalent, influencing market dynamics. Merck’s litigation against generic manufacturers and patent extensions in certain jurisdictions temporarily delayed generic entry, affording limited revenue retention. However, these advantages were ultimately temporary.

Emerging Trends and Future Outlook

The future of CRIXIVAN's market position hinges on global health initiatives, patent strategies, and the development of next-generation protease inhibitors. While broader HIV treatment continues to evolve towards fixed-dose combinations and long-acting injectables—such as cabotegravir/rilpivirine—older protease inhibitors like indinavir are increasingly relegated to niche or salvage therapy roles.

In low- and middle-income countries, however, affordability remains a key driver. Generics ensure continued access, maintaining a modest market for CRIXIVAN analogs, although sales volumes are expected to plateau or decline with the widespread adoption of newer global guidelines favoring integrase strand transfer inhibitors (INSTIs).

Financial and Strategic Implications for Stakeholders

• Pharmaceutical Companies: The lifecycle of CRIXIVAN exemplifies the importance of patent management, R&D innovation, and market diversification. Companies must anticipate patent cliffs and invest early in next-generation therapies.
• Investors: Revenue trends underscore risks associated with mature drugs approaching patent expiry. Portfolio diversification toward pipeline products can buffer revenue fluctuations.
• Health Authorities & Payers: Cost considerations favor generics; thus, policies promoting competition and access influence demand. Strategic procurement in resource-constrained settings sustains a residual market for older drugs.

Conclusion

CRIXIVAN’s market dynamics exemplify a drug transitioning from a pioneering therapy to a generic staple in HIV treatment. The drug’s financial trajectory underscores the impact of patent expiry, competitive pressures, and therapeutic innovation. While current revenues are modest and declining, the drug’s role in specific markets persists, emphasizing the importance of strategic adaptation in the pharmaceutical industry.

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Key Takeaways

• The initial blockbuster status of CRIXIVAN was driven by its groundbreaking role in HIV therapy, with revenues peaking in the late 1990s.
• Patent expiration in 2010 triggered a sharp decline in revenue due to generic competition and price erosion.
• Strategic alliances and licensing helped mitigate revenue loss, especially in resource-limited markets.
• The global shift toward newer antiretrovirals has relegated CRIXIVAN to a secondary role, with future prospects limited by rapid innovation in HIV therapeutics.
• The case underscores the importance of proactive patent and R&D strategies to sustain long-term market relevance.

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FAQs

1. What factors contributed to the decline in CRIXIVAN’s market share?
Patent expiration, emergence of superior drugs with better tolerability and resistance profiles, and widespread availability of generics significantly reduced CRIXIVAN’s market share.

2. How is CRIXIVAN positioned in current HIV treatment regimens?
It remains a secondary option largely in resource-limited settings or for patients with resistance to newer drugs, but it is seldom used as a first-line agent.

3. What legal actions impacted CRIXIVAN’s market trajectory?
Patent disputes and litigation delayed generic entry in some jurisdictions; however, patent expiry ultimately permitted widespread generic manufacturing.

4. Are there upcoming innovations that could revive CRIXIVAN’s relevance?
Current HIV research favors long-acting injectables and novel drug classes, which are unlikely to bolster older protease inhibitors like indinavir.

5. What lessons can pharma companies learn from CRIXIVAN’s lifecycle?
Early and strategic planning for patent expiry, continuous R&D innovation, and diversification across therapeutic classes are crucial to sustain revenue streams.

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References

1. [1] U.S. Food and Drug Administration. Approval of Indinavir for HIV/AIDS. 1996.
2. [2] IMS Health. Global HIV Pharmacare Market Reports. 2022.
3. [3] WHO. Guidelines on the Use of Antiretroviral Drugs. 2021.
4. [4] Merck & Co. Financial Reports. 2010–2022.
5. [5] MarketWatch. HIV Drug Market Trends. 2023.