Last updated: February 21, 2026
What is NDC 70000-0362?
NDC 70000-0362 corresponds to Emtricitabine and Tenofovir Alafenamide (TAF) Tablets, 200 mg/25 mg. This combination is used in the treatment of HIV-1 infection.
Market Landscape
Market Size & Growth Trends
- The global HIV treatment market was valued at $25 billion in 2021, with an expected compound annual growth rate (CAGR) of approximately 4.8% through 2027 [1].
- Emtricitabine/TAF is part of the nucleoside reverse transcriptase inhibitors (NRTIs) segment, which accounted for a significant portion of HIV meds sales.
- The emphasis on TAF over tenofovir disoproxil fumarate (TDF) is driven by improved safety profiles, particularly reduced renal and bone toxicity.
Key Competitors
| Product Name |
Dosage |
Manufacturer |
Market Share (2022) |
Price (Estimated US$) |
| Genvoya (Elvitegravir, Cobicistat, TAF, Emtricitabine) |
150/150/10/200 mg |
Gilead Sciences |
~40% |
$2,400/month* |
| Descovy (Emtricitabine, TAF) |
200 mg / 25 mg |
Gilead Sciences |
~20% |
$2,600/month* |
| Biktarvy (Bictegravir, TAF, Emtricitabine) |
50/200/50 mg |
Gilead Sciences |
~25% |
$2,400/month* |
*Prices are approximate wholesale acquisition costs (WAC), subject to reductions through insurance and negotiations.
Patent Landscape
- Patent protection for Gilead's TAF formulations extends into mid-2020s, with exclusivity for some formulations expiring around 2025–2027 [2].
- Generic versions expected to enter the market thereafter could pressure prices downward.
Regulatory Status & Launch Timeline
- The drug is FDA-approved and marketed as a component of combination regimens like Biktarvy.
- No recent FDA approvals for monotherapy; marketed mainly as part of fixed-dose combinations.
Price Projections
Short-term (Next 1-2 Years)
- Wholesale prices are expected to remain stable at approximately $2,400–$2,600 per month for branded formulations.
- Price reductions might occur due to enhanced insurance negotiations or supply chain optimization, but significant drops are unlikely before patent expiry.
Mid-term (2-5 Years)
- With patent expirations anticipated around 2025–2027, generic versions could reduce prices by 30-50%.
- Entry of generics might establish new wholesale levels around $1,200-$1,400 per month.
Long-term (Beyond 5 Years)
- Market share shifts to generics could reduce prices further.
- Price for initial branded formulations could decline as competitive dynamics evolve, possibly stabilizing at $1,000–$1,200 per month or lower for generics.
Market Drivers & Risks
Drivers
- Growing global HIV prevalence, especially in low-to-middle income countries.
- Increased adoption of TAF-based regimens over TDF, driven by safety benefits.
- Patent expirations and entry of generics.
Risks
- Pricing pressures intensify with generic competition.
- Regulatory or market access barriers in key regions.
- Development of resistance or new drug formulations.
Summary of Key Data Points
| Aspect |
Data Point |
| Market size (2021) |
$25 billion |
| Annual growth rate (2022–2027) |
4.8% |
| Branded drug prices |
~$2,400–$2,600/month |
| Patent expiration |
~2025–2027 |
| Generic entry impact |
30–50% price reduction expected |
Key Takeaways
- NDC 70000-0362 (Emtricitabine/TAF tablets) occupies a substantial share of the HIV treatment market, with stable prices currently.
- Market growth is driven by increased HIV prevalence and the preference for TAF-based regimens.
- Price reductions are anticipated following patent expirations in the mid-2020s, with generics significantly lowering costs.
- Supply chain negotiations and insurance coverage heavily influence actual prices paid in various markets.
FAQs
What is the main differentiator of Emtricitabine/TAF compared to older therapies?
TAF offers a better safety profile, with less impact on renal and bone health than TDF.
When are generics expected to enter the market?
Patent cliffs are projected around 2025–2027, after which generic versions will likely be available.
How does insurance coverage affect the drug’s price?
Insurance negotiations can substantially reduce out-of-pocket costs, but wholesale prices generally remain stable until generics enter.
Are there significant regional price differences?
Yes; prices for HIV meds vary globally based on market size, reimbursement policies, and negotiated discounts.
What are the key risks for price erosion?
Patent expiration, generic competition, and regulatory changes pose risks to sustained high prices.
References
[1] MarketWatch. (2022). HIV treatment market size and forecast. Retrieved from https://www.marketwatch.com/
[2] U.S. Patent and Trademark Office. (2023). Patent expiration summaries for Gilead Sciences. Retrieved from https://www.uspto.gov/
