Indinavir sulfate - Generic Drug Details

What are the generic sources for indinavir sulfate and what is the scope of patent protection?

Indinavir sulfate is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for indinavir sulfate.

Summary for indinavir sulfate

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	81
What excipients (inactive ingredients) are in indinavir sulfate?	indinavir sulfate excipients list
DailyMed Link:	indinavir sulfate at DailyMed

Recent Clinical Trials for indinavir sulfate

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

Sponsor	Phase
Oncology Institute of Southern Switzerland	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A
PPD	Phase 3

See all indinavir sulfate clinical trials

Medical Subject Heading (MeSH) Categories for indinavir sulfate

HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for indinavir sulfate

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

US Patents and Regulatory Information for indinavir sulfate

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 indinavir sulfate

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	6,689,761
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-006	Apr 19, 2000	5,413,999
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-001	Mar 13, 1996	5,413,999
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	Mar 13, 1996	6,689,761
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-005	Dec 17, 1998	6,689,761

Indinavir sulfate Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics of Indinavir Sulfate?

Indinavir sulfate, an HIV protease inhibitor, was introduced in the late 1990s as part of combination antiretroviral therapy (ART). Its market share was significant during the early 2000s but has declined due to several factors.

Current Market Position

• Market presence: Limited; largely phased out in favor of newer protease inhibitors like darunavir and atazanavir.
• Manufacturers: Several pharmaceutical firms, including Merck, initially produced it.
• Availability: Approximately 10-15 generic versions exist as of 2023, following patent expirations.

Drivers of Market Dynamics

• Patent expiration: Patent expiry in 2010 led to widespread generic manufacturing, reducing prices and margins.
• Clinical shifts: Transition toward drugs with better tolerability profiles, fewer drug-drug interactions, and simplified dosing regimens.
• Pricing competition: Generics have driven prices down, roughly a 70-80% decline since peak patent-protected prices.
• Regulatory status: Approval mostly limited to generic manufacturers; no recent approvals for new formulations or indications.

Key Market Factors

• Global HIV prevalence: Over 38 million people live with HIV globally (UNAIDS, 2022). Indinavir's role has diminished in favor of once-daily, combination regimens.
• Treatment guidelines: Major health authorities, including WHO and CDC, now favor integrase inhibitors over protease inhibitors like indinavir.
• Market segmentation: Primarily used in low- and middle-income countries via generic channels for cost-sensitive treatments.

Market Outlook

• Forecast period (2023-2028): Anticipated further decline as older protease inhibitors get replaced by newer agents.
• Potential niches: Limited—may persist in manufacturing for existing stock or in regions with restricted access to newer drugs.

What Are the Financial Trajectories for Indinavir Sulfate?

Historical Revenue and Sales

• Peak sales: Estimated at $800 million globally in 2002.
• Decline: By 2015, annual sales dropped below $50 million due to generic competition and treatment evolution.
• Current revenue: Approximates $10-20 million annually, primarily from generic sales in developing countries.

Cost and Pricing Trends

• Original branded price: Approximately $1,000-$1,500 per month per patient in 2000.
• Generic pricing: Declined to $50-$100 per month, depending on region and supplier.
• Manufacturing costs: Estimated at $5-$10 per dose, far below retail prices, indicating high profit margins during patent protection.

Investment and R&D Outlook

• Research activity: Minimal; no recent clinical trials or new formulations.
• Patent status: Expired; no further patent litigation or exclusivity prospects.
• Market entry costs: Low for generics; high investment required for reformulation or new indications.

Profitability & Investment Considerations

• The decline in demand and absence of innovation reduce investment appeal.
• Generic manufacturers operate on thin margins, with profits driven predominantly by volume.
• Pharmaceutic companies preemptively shift focus toward newer, more profitable therapies.

How Do These Market and Financial Factors Compare?

Aspect	Indinavir Sulfate (2000s)	2023 Position
Market Share	Significant in HIV treatments	Minimal, mostly generics
Revenue	Up to $800 million annually	$10-20 million predominantly in generics
Patent Status	Patent expired (2010)	No active patents
Pricing	Original: ~$1,000/month; generics: ~$50	Low-margin, volume-driven
Treatment Role	First-line in some settings	Replaced by newer agents

Key Takeaways

• Indinavir sulfate's market has contracted substantially since patent expiry.
• Market dynamics favor generics and lower-cost treatments for HIV.
• The financial trajectory shows a steady decline in revenue and profitability.
• Treatment guidelines continue to phase out indinavir in favor of drugs with improved safety and convenience.
• Limited investment activity persists due to the drug’s obsolescence and lack of innovation prospects.

FAQs

1. Is indinavir sulfate still available for prescription?
Mostly in generic form for existing stocks. No new approvals for prescriptions or formulations.

2. What are the primary alternatives to indinavir sulfate?
Integrase inhibitors like dolutegravir and bictegravir, and newer protease inhibitors such as darunavir.

3. Will indinavir sulfate see renewed interest or reformulation?
Unlikely; the drug’s role has been effectively phased out in treatment guidelines.

4. How does the pricing of indinavir compare globally?
Prices vary widely: in high-income countries, it is mostly unavailable; in low-income regions, it is sold at a few dollars per dose.

5. What is the outlook for similar older protease inhibitors?
Most face similar declines, with market exit or role reduction driven by newer drugs with better profiles.

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Sources:

1. UNAIDS. (2022). Global HIV & AIDS statistics.
2. U.S. Food and Drug Administration. (2010). Patent expiration dates.
3. IMS Health. (2015). Anti-HIV market analysis.
4. WHO treatment guidelines for HIV. (2022). Updated recommendations.
5. Market research reports from IQVIA. (2023). HIV drug market trajectories.