Last updated: February 20, 2026
What Is NDC 69238-1126?
NDC 69238-1126 is a registered National Drug Code (NDC) that identifies a specific pharmaceutical product. Based on available data, it corresponds to a medication manufactured by Apotex Corp. designed for prescription use. Its active ingredient and formulary details are vital for understanding its market positioning.
Active Ingredient and Therapeutic Class
The product contains doravirine, an antiretroviral medication used in the treatment of HIV-1 infection. It is a non-nucleoside reverse transcriptase inhibitor (NNRTI) prescribed for patients requiring combination antiretroviral therapy.
Market Overview
Indication and Prescribing Trends
The drug's core market includes HIV-1 infected patients. The global HIV treatment market grew at a compound annual growth rate (CAGR) of approximately 4.5% from 2015 to 2021. The increasing prevalence of HIV, estimated at 38 million globally as of 2021, sustains demand (UNAIDS, 2022).
In the United States, the Centers for Disease Control and Prevention (CDC) reports around 1.2 million individuals living with HIV, with approximately 60,000 new diagnoses annually. The adoption of newer antiretroviral agents, including doravirine, reflects ongoing shifts toward simplified, once-daily regimens with fewer side effects.
Competitive Landscape
Major competitors include:
- Atripla (efavirenz/emtricitabine/tenofovir)
- Biktarvy (bictegravir/emtricitabine/tenofovir)
- Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate)
Doravirine's market share remains small but growing due to its favorable tolerability profile. As of 2022, roughly 15% of new HIV prescriptions incorporate doravirine components.
Regulatory and Patent Status
Doravirine received FDA approval in 2018. The patent protections for the original formulations will expire between 2023 and 2025, opening opportunities for generic competition.
Price Trends and Projections
Historical Price Data
- Brand name (brand approach like Delstrigo): Approximately $3,800–$4,200 per month (CPI-adjusted) in 2022.
- Generic equivalents (e.g., non-branded doravirine): Estimated at $1,200–$1,400 per month, based on recent launches.
Price Drivers
- Patent expiration: Expected between 2023–2025.
- Generic entry: Will substantially decrease prices by an estimated 50–70%.
- Market penetration: Increasing acceptance of generics can accelerate price erosion.
- Reimbursement policies: Insurance coverage influences retail pricing and out-of-pocket cost.
Price Projections (Next 3 to 5 Years)
| Year |
Estimated Average Price (USD/month) |
Notes |
| 2023 |
$3,700–$4,200 (brand); $1,200–$1,400 (generic) |
Transition phase, patent expiry begins |
| 2024 |
$2,100–$2,800 (generic share increases) |
Generic uptake accelerates |
| 2025 |
$1,000–$1,500 (dominant generics) |
Market normalization, minimal brand price |
Market Share Projections
- 2022: 15% of new prescriptions; $4,000/month average price.
- 2025: 70–80% market share for generics; prices at about $1,200/month.
- Long-term (2027+): Market stabilization with generics representing 85% or more of prescriptions.
Conclusion
The financial trajectory of NDC 69238-1126 hinges on patent behavior and generic regulatory approvals. Significant price declines are inevitable once patent protections lapse, with the potential for substantial market share redistribution toward generics. The nascent market for doravirine indicates a gradual price decrease, stabilizing around $1,000–$1,500 per month within three years.
Key Takeaways
- NDC 69238-1126 correlates with a doravirine-based antiretroviral.
- The U.S. HIV treatment market is steady, driven by rising prevalence and evolving prescriber preferences.
- Patent expirations from 2023 increase market entry of generics.
- Expected price reduction: 60–70% upon generic entry.
- Market share for doravirine is projected to grow, with generics dominant by 2025.
FAQs
1. What are the primary factors influencing the price of NDC 69238-1126?
Patent expiration, generic competition, prescribing trends, and reimbursement policies determine pricing dynamics.
2. When is patent expiration expected for the original doravirine formulations?
Between 2023 and 2025, depending on the specific patent and exclusivity data.
3. How does generic competition impact profitability for innovators?
Pricing drops significantly, often between 50–70%, reducing margins for brand-name manufacturers.
4. What is the potential for biosimilars or alternative formulations?
Limited for this small-molecule drug; focus remains on generics.
5. How do market trends affect investment opportunities?
Growing generic market share and potential volume increases support opportunities post-patent expiry.
References
[1] UNAIDS. (2022). Global AIDS update 2022. UNAIDS.
[2] U.S. Food and Drug Administration. (2018). FDA approval of first doravirine-based HIV treatment.
[3] IQVIA. (2022). National Prescription Audit: HIV medications.
[4] Medicare Part D drug pricing data. (2022).
[5] Evaluate Pharma. (2022). Market forecasts for HIV medications.
