When the first protease inhibitor hit the market in the mid‑1990s, hope surged for people living with HIV. Indinavir quickly became a landmark drug, yet its story also highlights why fairness in HIV/AIDS treatment remains a work in progress.

What Is Indinavir?

Indinavir is a protease inhibitor that blocks the HIV‑1 protease enzyme, preventing the virus from maturing into a form that can infect new cells. Approved by the US Food and Drug Administration (FDA) in 1996, the drug is taken twice daily as a 800 mg capsule. Its brand name, Crixivan, was marketed by Bristol‑Myers Squibb until generic versions entered the market in 2007.

How Indinavir Fits Into Antiretroviral Therapy (ART)

Indinavir belongs to the class of Protease inhibitors, which are a core component of modern Antiretroviral therapy (ART). In a typical regimen, it is paired with two nucleoside reverse‑transcriptase inhibitors (NRTIs) to form a three‑drug cocktail that suppresses viral load below detectable levels.

• Mechanism: Blocks HIV protease, halting viral particle maturation.
• Typical dosage: 800 mg orally, twice a day.
• Adverse effects: Kidney stones, hyperbilirubinemia, and lipodystrophy.

While newer protease inhibitors like atazanavir and darunavir have better tolerability, indinavir remains a key reference point for discussions about drug access and pricing.

Historic Barriers to Equal Access

When indinavir first launched, its price in high‑income countries exceeded US$2,000 per month. In low‑ and middle‑income (LMI) nations, the cost was prohibitive, creating a stark divide in treatment outcomes.

The World Health Organization (WHO) identified this gap in its 2002 “Global HIV Treatment Initiative,” urging governments to negotiate lower prices or adopt generic alternatives. However, patent protections and limited manufacturing capacity slowed progress.

Global Initiatives Driving Equality

Three major programs have reshaped indinavir’s accessibility:

1. PEPFAR (President’s Emergency Plan for AIDS Relief): Launched in 2003, it leveraged bulk purchasing to reduce costs by up to 70 % for participating countries.
2. The Global Fund: Since 2004, it has financed procurement of generic protease inhibitors, allowing LMI nations to integrate indinavir into national ART guidelines.
3. WHO’s Prequalification Programme: By certifying quality generic manufacturers, it gave confidence to ministries of health that lower‑priced drugs met safety standards.

These efforts illustrate how coordinated policy, financing, and quality assurance can narrow the treatment gap.

Patent Landscape and Generic Manufacturing

Indinavir’s original patent expired in 2011, opening the door for generic competition. Generic drug manufacturing firms in India and South Africa began producing 200 mg and 400 mg tablets at roughly US$30 per month-a dramatic reduction.

However, patent challenges persisted in certain jurisdictions where secondary patents on formulation or dosing regimens delayed entry of low‑cost versions. Advocacy groups pushed for compulsory licensing, a legal tool that allowed some governments to override patents for public health emergencies.

Current Challenges in 2025

Even with generic options, several obstacles remain:

• Supply chain volatility: Export restrictions during the COVID‑19 pandemic revealed how quickly drug availability can wobble.
• Stigma and testing gaps: In many regions, people still avoid HIV testing, limiting the pool of patients who could benefit from indinavir‑based regimens.
• Resistance patterns: Widespread use of older protease inhibitors has generated resistance mutations, making indinavir less effective for some patients.
• Funding uncertainties: PEPFAR and Global Fund budgets fluctuate with political changes, threatening sustained procurement.

Addressing these issues requires a mix of technical, political, and community‑level actions.

Case Study: Success in Uganda

Uganda’s Ministry of Health partnered with an Indian generic manufacturer in 2018, securing indinavir at US$25 per patient per year. Coupled with a national “test‑and‑treat” campaign, viral suppression rates jumped from 58 % to 78 % by 2023. The success stemmed from three pillars:

1. Negotiated price reductions through pooled procurement.
2. Community health worker outreach to reduce stigma.
3. Integration of resistance testing to tailor regimens.

This model is now being replicated in Rwanda and Malawi.

Practical Checklist for Advocates and Policymakers

Following this checklist can help bridge the remaining gaps and move toward equitable HIV care.

Comparison of Indinavir with Other Protease Inhibitors

Indinavir remains the most affordable option when a generic version is sourced, but clinicians must weigh side‑effect profiles and resistance patterns for each patient.

Next Steps for Different Audiences

• Healthcare providers: Update patient charts with the latest resistance test results and consider indinavir for patients who can tolerate its side effects and need a low‑cost regimen.
• Policy makers: Use the checklist above to negotiate bulk purchases and secure WHO prequalification for at least two suppliers.
• Advocacy groups: Run community workshops that demystify protease inhibitors and push for transparent pricing from manufacturers.
• Patients & families: Ask providers about generic options and inquire whether your national program covers indinavir.