Last updated: March 4, 2026
What is NDC 00456-1550?
NDC 00456-1550 corresponds to Rilpivirine, 25 mg tablets, marketed primarily under the brand name Edurant. It is an antiretroviral drug used in combination therapy for HIV-1 infection. It belongs to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.
Market Position and Demand Drivers
The demand for rilpivirine derives from its role in HIV treatment regimens. The global HIV drug market was valued at approximately $23 billion in 2021, with NNRTIs making up a significant portion, roughly 25%.[1] The market for rilpivirine specific drugs is influenced by:
- HIV prevalence: Estimated at 38 million globally (UNAIDS, 2022)[2]
- Patent status: Patent expiry potential impacts generic entry
- Pricing competition: Introduction of generics reduces market prices
- Regulatory approvals: Expansion into new markets or new formulations (combination pills)
The drug's market share is around 8-10% within the HIV antiretroviral segment, driven largely by its tolerability and once-daily dosing.
Competitive Landscape
Major competitors include:
| Drug Name |
Class |
Market Share (Est.) |
Patent Status |
Notes |
| Efavirenz (Sustiva) |
NNRTI |
50% |
Patent expired (2018) |
Widely used, now generics available |
| Doravirine (Pifeltro) |
NNRTI |
15% |
Patented (expiring 2027) |
Newer alternative, favorable profile |
| Rilpivirine (Edurant) |
NNRTI |
8-10% |
Patent protected (until 2027) |
Prescribed as alternative in some regimens |
Price Trajectory and Projections
Current Pricing (Branded vs. Generic)
| Price Factor |
Estimated Price (per 30-day supply) |
| Brand (Edurant) |
$3,200 - $3,500 |
| Generic equivalents (estimated) |
$150 - $300 |
The high branded price persists due to patent protection and limited generic competition. Upon patent expiration, prices are expected to decline significantly.
Price Trends and Projection
| Year |
Expected Price Range (per 30-day) |
Key Factors |
| 2023 |
$3,100 - $3,500 |
Patent protection remains intact |
| 2024 |
$2,800 - $3,200 |
Approaching patent expiry; generic approval in some markets |
| 2025 |
$1,500 - $2,000 |
Generic market entry, increased competition |
| 2026 |
$150 - $300 |
Dominance of generics, minimal branded sales |
Potential Impact of Patent Expiration
The patent for rilpivirine in the US expires in 2027. Generic entry can reduce prices by 80-90%, accelerating the market share shift and shrinking revenue for branded formulations.
Market Size and Revenue Forecasts
Based on current usage patterns, and assuming steady uptake:
| Year |
Estimated Unit Sales (millions of 30-day supplies) |
Revenue (USD millions) |
| 2023 |
3.5 |
$10,000 - $12,000 |
| 2024 |
3.8 |
$8,600 - $11,200 |
| 2025 |
4.2 |
$6,300 - $8,400 |
| 2026 |
4.5 |
$675 - $1,350 (post-generic) |
Sales are expected to decline sharply after 2027 as generics dominate.
Regulatory and Policy Considerations
- Patent challenges and biosimilar approvals could shift price trajectories.
- Pricing negotiations in national healthcare systems impact revenue.
- Inclusion in treatment guidelines influences prescribing patterns, especially in lower-income countries.
Summary
NDC 00456-1550 (rilpivirine) maintains a branded price around $3,200 for a 30-day supply, with sales driven mainly by HIV treatment pipelines. Its market share has plateaued due to competition from other NNRTIs and emerging integrase inhibitors. Patent expiration in 2027 is likely to trigger substantial price reductions and volume increases with the entry of generics. Providers should monitor regulatory actions and patent litigations that could influence the timeline and scope of generic entry.
Key Takeaways
- Rilpivirine holds approximately 8-10% of the HIV antiretroviral market.
- Branded price is approximately $3,200 per month; generics expected to reduce prices by 80-90% post-2027.
- Revenue forecasts decline after patent expiration, but volume is likely to rise with generic access.
- Market shares are shifting toward newer drugs, emphasizing the need to consider pipeline competition.
- Policy and regulatory developments can accelerate generic penetration, affecting future pricing and revenue.
FAQs
1. When does the patent for rilpivirine (NDC 00456-1550) expire?
Patent expiry in the US is scheduled for 2027; other markets may vary.
2. How will generic entry affect rilpivirine prices?
Prices are projected to fall by up to 90%, significantly impacting revenue for brand manufacturers.
3. Are there approved biosimilar or generic versions globally?
Generic versions are pending approval in some markets; none are widely available yet.
4. What factors influence the adoption of rilpivirine in HIV treatment?
Efficacy, tolerability, drug interactions, and inclusion in treatment guidelines.
5. What is the outlook for rilpivirine on the market?
Long-term, the market is expected to decline as newer agents with better profiles enter the market.
References
[1] IQVIA. (2022). HIV market report.
[2] UNAIDS. (2022). Global HIV & AIDS statistics.
