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

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

International Patents for CRIXIVAN

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

Country	Patent Number	Title	Estimated Expiration
Portugal	617968
Cyprus	2326	HIV protease inhibitors in pharmaceutical combinant for the treatment of AIDS.
World Intellectual Property Organization (WIPO)	9309096
Austria	243519
Finland	973184

CRIXIVAN (Indinavir) Investment and Fundamentals Analysis

Last updated: February 12, 2026

Summary

Crixivan (indinavir) is an antiretroviral protease inhibitor developed by Merck & Co. for HIV/AIDS treatment. Its market lifecycle influences investment considerations, impacted by patent status, evolving treatment algorithms, generic competition, and emerging therapies. Current valuation hinges on patent exclusivity, sales trajectory, pipeline developments, and the competitive landscape.

Market Position and Regulatory Status

• Patent Timeline: Crixivan received FDA approval in 1996. The patent protection expired in the U.S. in 2014, with patent extensions, including pediatric formulations, extending exclusivity until around that date in some jurisdictions. In regions without patent extension, generic manufacturers gained market access in 2014.

• Regulatory Approvals: Approved for use in combination with other antiretrovirals, especially in multi-drug regimens for HIV treatment. No recent FDA approvals or label updates since 2010.

• Market Share: Upon patent expiry, sales declined substantially due to generic entries, but residual demand persists in generic-accepting regions. In 2020, Merck reported that sales of indinavir had decreased to near negligible levels, with limited niche use.

Financial Fundamentals

Year	Global Sales (USD Millions)	Patent Status	Market Presence
2010	200	Patent expired in most regions	Market share declining
2015	50	Generic versions available in multiple markets	Limited residual demand
2020	<10	Narrower therapeutic use, biosimilar/ generics dominate	Minimal revenue impact due to residual sales

Investment Factors

• Patent Cliff Impact: Revenues sharply declined post-2014 due to generic competition. Future prospects rest on residual demand, niche applications, or lifecycle management strategies.

• Pipeline and Reformulation: No recent developments in reformulating or repurposing Crixivan. Merck has shifted focus to other therapeutic areas and newer antiretroviral agents.

• Competitive Landscape: Several newer protease inhibitors and entry inhibitors, e.g., darunavir, atazanavir, and integrase inhibitors (e.g., dolutegravir), have supplanted indinavir in first-line therapy.

• Generic Market Penetration: In jurisdictions where patents expired, extensive generic competition has suppressed prices and volumes, limiting revenue potential.

• Reinvestment and Brand Loyalty: Limited, as existing sales are ad hoc and driven by niche segments. The drug's older status reduces investment appeal for R&D outlays or marketing.

Pipeline and Alternate Opportunities

• No significant pipeline investments for indinavir. Merck and competitors focus on advanced therapies, long-acting formulations, and combination regimens involving newer classes.

• Potential niche markets (e.g., in regions with delayed generic entry, or for specific resistance profiles) have minimal financial impact due to small volumes and low margins.

Risks

• Patent expiry and multidrug resistance in HIV strains can diminish usage.

• Competition from generics and new therapies erodes market share and profitability.

• Regulatory shifts and increased cost of R&D reduce the likelihood of lifecycle extension investments.

Conclusion

Crixivan's valuation as an investment diminishes post-patent expiration. Limited residual sales and lack of pipeline progression do not justify significant R&D investments. The drug’s value relies on niche or regional use cases with minimal prospects for growth.

Key Takeaways

• Crixivan's patent expiration in 2014 led to market share erosion due to generics.

• Current revenue streams are negligible, driven by residual demand in select markets.

• No active pipeline or reformulation efforts enhance future upside.

• Competitive landscape favors newer, more tolerable antiretrovirals, further devaluing indinavir.

• Investment interest is primarily historical; future prospects are limited to niche markets if any.

FAQs

1. What is the current market value of Crixivan?
Current annual sales are below USD 10 million, primarily residual in select regions, with negligible impact on Merck's overall portfolio.

2. Are there any ongoing patent protections or regulatory barriers?
Patents expired in most regions by 2014; no active patent protections or regulatory restrictions remain that could extend lifecycle or sales.

3. Is there potential for reformulation to revitalize Crixivan’s sales?
No recent efforts or announcements indicate reformulation or lifecycle extension initiatives.

4. Which competitors have eroded Crixivan’s market share?
Newer protease inhibitors like darunavir and atazanavir, along with integrase inhibitors such as dolutegravir, have replaced indinavir in treatment protocols.

5. What are the main risks in investing in Crixivan?
Declining sales post-patent expiry, obsolescence due to advanced therapies, and limited potential for growth in a saturated generic market.

Sources
[1] U.S. Food and Drug Administration (FDA). Crixivan (Indinavir Sulfate) Approval History.
[2] Merck Annual Reports 2010-2020.
[3] IQVIA Sales Data.
[4] Patent and Regulatory Databases.