Last updated: February 27, 2026
What is NDC 00713-0683?
The National Drug Code (NDC) 00713-0683 corresponds to Emtricitabine and Tenofovir Disoproxil Fumarate (generic brand: Truvada). Approved by the FDA in 2004, this combination medication is used primarily for HIV-1 treatment and pre-exposure prophylaxis (PrEP).
Market Overview
Current Market Size
The global HIV therapy market was valued at approximately $21.7 billion in 2022. The United States holds about 50% of this market, reflecting high prescription rates for HIV medications like Truvada.
Key Competitors
- Gilead Sciences (brand: Truvada, Descovy)
- Teva Pharmaceuticals (generic versions)
- Mylan (generic versions)
- Cipla
- Sun Pharmaceuticals
Patent Status and Market Entry
Gilead's patents for Truvada expired in 2020, opening the door for generic competition. Several companies now market generic equivalents, reducing prices and expanding access.
Regulatory Landscape
- Pending generic approvals from FDA, with multiple applications submitted since patent expiration.
- Increasing emphasis on affordability, driving policies favoring generics.
- WHO recommends PrEP globally, expanding market scope.
Market Drivers
- Growing HIV prevalence worldwide, estimated at 38 million people in 2022.
- Rising adoption of PrEP in the U.S. and Europe.
- Generic availability leading to price reductions.
- Increasing awareness and healthcare initiatives targeting HIV prevention.
Price Trends and Projections
Present Pricing
- Brand-name Truvada: Retail price approximately $1,800–$2,000 per month without insurance.
- Generic versions: Prices typically range from $300 to $600 per month.
Pricing Comparison (2022–2023)
| Product Type |
Price Range per Month |
Market Share |
| Brand (Truvada) |
$1,800 – $2,000 |
80% |
| Generics |
$300 – $600 |
20% |
Price Projections (2024–2028)
- Assumption: Generic competition intensifies, leading to further price declines.
- Forecast:
- Entry of additional generics expected to reduce average prices by 30%–50%.
- The average generic price may stabilize at $200–$400 per month by 2028.
- Pricing trend: A gradual decline in generic prices with a potential plateau once market saturation occurs.
Revenue Forecast
| Year |
Estimated Market Volume (patients) |
Expected Revenue (billions) |
| 2023 |
1 million patients |
$2.5 billion |
| 2025 |
1.2 million patients |
$2.8 billion |
| 2028 |
1.4 million patients |
$2.9 billion |
Note: These estimates assume continued growth in PrEP adoption and HIV treatment coverage.
Market Risks and Opportunities
Risks
- Stringent patent litigation or delays in generic approvals.
- Changes in healthcare policy affecting reimbursement.
- Potential emergence of novel therapies or formulations that could replace existing ones.
Opportunities
- Expansion into emerging markets with higher HIV prevalence.
- Increased uptake of PrEP in high-risk populations.
- Development of long-acting formulations reducing dosing frequency.
Summary of Price and Market Outlook
| Aspect |
2023 |
2028 |
| Brand Price |
~$1,900/month |
No significant change |
| Generic Price |
$300–$600/month |
$200–$400/month |
| Market Growth Rate |
Approximately 8% annually |
Stabilizing near 3–4% |
| Potential for Price Reductions |
Likely due to increased generic use |
Continued but slower declines |
Key Takeaways
- Patent expiration in 2020 shifted market dominance toward generics.
- Prices for generics are expected to decline further, affecting revenue streams.
- The market's growth depends on PrEP adoption, global HIV prevalence, and regulatory policies.
- Market saturation with generics is anticipated around 2028, stabilizing prices.
FAQs
1. What factors influence generic pricing for NDC 00713-0683?
Manufacturing costs, market competition, regulatory approval delays, and distribution channels determine generic pricing.
2. How does patent expiry impact the market size for this drug?
Patent expiry enables generic entry, which increases access and expands the market by lowering prices.
3. Are there new formulations or alternatives expected to affect this drug's market?
Yes, long-acting injectables and other novel therapies are progressing, which could substitute daily oral regimens.
4. How do global health initiatives influence market projections?
Programs promoting HIV prevention and treatment, especially in low-income countries, expand the market.
5. What is the risk of price volatility for this drug?
Price volatility is primarily driven by regulatory delays, patent litigation, or supply chain disruptions.
References
[1] Statista. (2023). HIV therapy market size and trends. https://www.statista.com/
[2] U.S. Food and Drug Administration. (2022). Approved drug products. https://www.fda.gov/
[3] IQVIA Institute. (2022). The global HIV treatment landscape. https://www.iqvia.com/
[4] World Health Organization. (2022). Pre-exposure prophylaxis (PrEP) guidelines. https://www.who.int/
