Last updated: February 27, 2026
What is NDC 16714-0227?
NDC 16714-0227 refers to Rilpivirine, 25 mg, a non-nucleoside reverse transcriptase inhibitor used in combination therapy for HIV-1 infection. It is marketed under brand names such as Edurant by Janssen Pharmaceuticals.
Market Overview
Indications and Usage
Rilpivirine is approved for adult patients infected with HIV-1 as part of combination antiretroviral therapy (ART). It is prescribed as a once-daily oral tablet.
Market Size and Growth
Global HIV treatment market details:
- Estimated 38 million people living with HIV worldwide (UNAIDS, 2022).
- The ART market had a value of approximately US$ 21 billion in 2022.
The growth rate of the HIV medication sector has been steady at approximately 4-6% annually in recent years, driven by increased diagnosis, improved access in developing regions, and new treatment guidelines emphasizing single-pill formulations.
Competitive Landscape
Main competitors include:
- Efavirenz (Sustiva)
- Dolutegravir (Tivicay, ViiV Healthcare)
- Bictegravir (Biktarvy)
- Atripla and Complera (combination products containing rilpivirine)
Market dominance resides with integrase inhibitor-based regimens, especially bictegravir-based products.
Patent and Regulatory Status
- U.S. patent expiry: 2028, with patent extensions possibly currently in effect.
- Rilpivirine has U.S. FDA approval since May 2011.
- Market exclusivity for branded Edurant continues until patent expiration unless biosimilar or generic formulations enter.
Price Trends and Projections
Current Pricing
- Branded Edurant (rilpivirine) 25 mg tablets retail at approximately $1,200–$1,500 per month in the U.S.
- Discounted prices for public payers and negotiated prices approximate $900–$1,200 per month.
Historical Price Changes
- Prices for rilpivirine have remained relatively stable since its launch, with minor reductions due to biosimilar/patent challenges.
- No substantial generic competition exists as of 2023.
Future Price Projections (2023–2028)
| Year |
Estimated Price Range per Month |
Assumptions |
| 2023 |
$950–$1,200 |
Stable patent protection, no generic entry |
| 2024 |
$900–$1,200 |
Slight downward trend due to market stabilization |
| 2025 |
$850–$1,150 |
Potential biosimilar development impacts pricing |
| 2026 |
$800–$1,100 |
Patent expiration approaches, generic competition rare |
| 2027 |
$750–$1,050 |
Possible biosimilar entry, limited impact expected |
| 2028 |
$700–$1,000 |
Patent expiry may lead to generic entry, pricing declines broad |
Factors Influencing Price Dynamics
- Patent expiry timeline and successful patent challenges.
- Introduction of biosimilars or generics.
- Pricing policies in major markets (U.S., Europe, emerging markets).
- Market penetration of alternative regimens (e.g., integrase inhibitors).
- Insurance and payer negotiations.
Market Entry and Competition Projections
- Generic rilpivirine likely to enter post-2028, strongly pressuring prices.
- Innovations in HIV therapy, including long-acting injectables, may shift prescription patterns away from rilpivirine.
- Price erosion expected to accelerate with increased biosimilar availability.
Summary
Rilpivirine (NDC 16714-0227) faces limited near-term competition due to patent protections, maintaining high prices. Price projections suggest gradual declines starting after 2028 with generic entry. Market share growth is constrained by evolving treatment standards favoring integrase inhibitor-based regimens.
Key Takeaways
- Current retail prices are approximately $1,200/month in the U.S.
- Price stability is expected through 2027, with reductions post-2028 driven by patent expiration.
- Competition from generics is unlikely before 2028.
- Market dynamics are influenced by emerging therapies and policy shifts.
- The global HIV treatment market continues steady growth, favoring established drugs in the short term.
FAQs
1. When will generic rilpivirine likely enter the market?
Post-2028, assuming patent expiry and successful patent challenges.
2. How will biosimilars affect rilpivirine pricing?
Biosimilars could lower prices by 20-50%, depending on market acceptance and regulatory pathways.
3. Are there any new formulations or delivery methods planned for rilpivirine?
No current developments; focus shifts toward long-acting injectables.
4. How does rilpivirine compare with competitors like dolutegravir?
Dolutegravir-based regimens are increasingly preferred due to better tolerability, fewer drug interactions, and superior resistance profiles.
5. What factors could accelerate price declines before patent expiry?
Entry of biosimilar or generic versions, regulatory decisions, or shifts in treatment guidelines favoring other drugs.
References
[1] UNAIDS. (2022). Global HIV & AIDS Statistics — 2022 Fact Sheet.
[2] IQVIA. (2022). Global HIV Treatment Market Report.
[3] FDA. (2011). Edurant (rilpivirine) Approval Letter.
[4] U.S. Patent and Trademark Office. (2023). Patent expiry dates for rilpivirine.
