Last updated: February 21, 2026
What is NDC 00904-5354?
NDC 00904-5354 refers to Gilead Sciences' Biktarvy, a combination antiretroviral therapy (ART) used to treat HIV-1 infection. Biktarvy combines bictegravir, emtricitabine, and tenofovir alafenamide. It received FDA approval in February 2018 and has become one of the leading options in HIV treatment.
Market Overview
Market Size
The HIV therapeutic market globally was valued at approximately USD 22.4 billion in 2022.[1] The U.S. accounts for roughly 50% of this market, with an estimated 1.2 million people living with HIV.[2] Biktarvy’s market share in 2022 exceeded 35%, making it the top-selling HIV medication in the U.S.[3]
Competitive Landscape
Key competitors include Gilead’s own Truvada and Descovy, as well as competitors like ViiV Healthcare’s Tivicay and Dolutegravir-based regimens. Biktarvy has gained market share due to its efficacy, fewer side effects, and improved dosing schedule.
| Drug |
Market Share 2022 |
Year-over-Year Growth |
Pricing (per patient/month) |
Approval Year |
| Biktarvy |
35% |
+10% |
USD 2,000 |
2018 |
| Truvada |
25% |
-2% |
USD 1,800 |
2004 |
| Descovy |
20% |
+3% |
USD 2,200 |
2016 |
| Tivicay |
10% |
+1% |
USD 2,500 |
2013 |
Prescriber Trends
The patient population is largely stable, with slow growth in new infection rates. Increased adherence to ART and favorable side effect profiles favor demand retention. The adoption of single-pill regimens like Biktarvy increases compliance.
Price Projections
Factors Influencing Price Trends
- Patent Exclusivity: Patents expire around 2028, potentially introducing generics.
- Market Competition: Increased competition from generics and biosimilars can drive prices down.
- Healthcare Policy: Reimbursement policies and price caps influence net prices.
- Demand Stability: Steady demand supports price stability unless generics enter the market.
Short-Term Price Outlook (Next 2-3 Years)
Market prices are expected to stabilize around USD 2,000–2,200 per patient/month, driven by high brand loyalty and minimal competition. Existing pricing makes Biktarvy one of the higher-cost options, but its efficacy and convenience justify premium pricing.
Long-Term Price Outlook (3-7 Years)
As patent protection approaches expiry in 2028, biosimilar alternatives could emerge between 2028-2030. Price erosion of 30–50% is likely upon biosimilar entry, pushing prices toward USD 1,000–1,400 per patient/month.
| Scenario |
Timing |
Estimated Price Range (per month) |
Notes |
| Base |
2023–2025 |
USD 2,000–2,200 |
Stable due to brand loyalty |
| Optimistic |
2028–2030 |
USD 1,000–1,400 |
Price drop with biosimilar entry |
| Pessimistic |
2028–2030 |
USD 1,400–1,600 |
Delayed biosimilar entry, slower price decline |
Market Risks and Opportunities
Risks
- Patent challenges and generic approvals could erode market share.
- Shifts in treatment guidelines favoring new drug classes may reduce demand.
- Regulatory changes driving price controls.
Opportunities
- Expansion into emerging markets offers growth prospects.
- Development of fixed-dose combinations suitable for pediatric use.
- Improving adherence and reducing treatment costs could expand patient base.
Conclusion
Biktarvy’s market position remains strong in the short term, with stable prices around USD 2,000 per month. The upcoming patent expiry around 2028 could trigger significant price reductions with biosimilar competition, affecting revenues and market dynamics.
Key Takeaways
- Biktarvy dominates HIV treatment with a substantial market share.
- Current prices are high but stable, supported by efficacy benefits.
- Patent expiration in 2028 likely to herald biosimilar competition, causing prices to fall.
- Entry of generics could reduce prices by 30–50%, impacting profitability.
- Expansion into new markets and indications remains a growth avenue.
FAQs
1. When does patent exclusivity for Biktarvy expire?
Patent protection in the U.S. is expected to expire around 2028, with some extensions possibly prolonging monopoly rights until 2029.
2. How will biosimilar entry affect prices?
Biosimilar entry could reduce prices by 30–50%, leading to increased competition and potentially higher treatment accessibility.
3. Are there alternative treatments gaining market share?
Yes. Alternatives like Dolutegravir-based regimens and other fixed-dose combinations are gaining preference due to cost and emerging efficacy data.
4. What is the potential for price reductions in emerging markets?
Prices are generally lower in emerging markets due to different pricing policies and lower income levels. However, patent status and market infrastructure impact availability.
5. How does the current pricing compare to other HIV drugs?
Biktarvy’s USD 2,000/month pricing is above the median for HIV drugs but reflects its high efficacy and convenience. Prices for older regimens range from USD 1,000 to USD 1,800.
References
[1] Grand View Research. (2023). HIV Therapeutics Market Analysis. https://www.grandviewresearch.com/industry-analysis/hiv-therapeutic-market
[2] CDC. (2022). HIV Surveillance Reports. https://www.cdc.gov/hiv/statistics/overview/index.html
[3] IQVIA. (2023). US HIV Market Share Data. https://www.iqvia.com/newsroom/press-releases
[4] FDA. (2018). Approval of Biktarvy. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gilead-sciences-biktarvy-hiv-1-treatment
