Last updated: February 25, 2026
What is the drug identified by NDC 64980-0513?
The National Drug Code (NDC) 64980-0513 corresponds to Cobicistat and Emtricitabine and Tenofovir Alafenamide Tablets, a component used in antiretroviral therapy for HIV-1 infection treatment. It is marketed under the brand name Descovy by Gilead Sciences.
Market Landscape
Current Market Position
- Indication: HIV-1 treatment, specifically as part of combination regimens.
- Market Share: Descovy is among the top-prescribed agents in the HIV antiretroviral class, directly competing with brands like Truvada.
- Launch & Approval Dates: Approved by FDA in October 2016.
- Key Competitors:
- Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate)
- Biktarvy (Gilead)
- Dolutegravir-based regimens (ViiV, Takeda)
Market Size
- The global HIV antiviral market was valued at approximately USD 9.2 billion in 2022.
- Gilead's HIV franchise, including Descovy, accounts for a significant portion due to high prescription volume.
- In the U.S., estimated annual sales of Descovy exceeded USD 1.7 billion in 2022.
Prescribing Trends
- Descovy is favored over Truvada for pre-exposure prophylaxis (PrEP) due to its lower renal toxicity profile.
- Recent shifts include increased adoption for PrEP, expanding the marketed population.
Price Analysis
Current Pricing
- Average Wholesale Price (AWP): Approximately USD 2,100 per 30-pack (one month supply), retail prices may range from USD 2,200 to USD 2,400.
- Average Selling Price (ASP): Estimated at USD 1,950 to USD 2,050, reflecting negotiated discounts.
- Reimbursed Rates: Medicare Part D, private insurers, and Medicaid typically cover substantial portions, with patient co-pays varying.
Price Comparisons
| Drug |
Pack Size |
Approximate AWP |
Notes |
| Descovy (NDC 64980-0513) |
30 tablets |
USD 2,100 |
Standard retail price |
| Truvada |
30 tablets |
USD 1,700 |
Older formulation, slightly cheaper |
| Biktarvy |
30 tablets |
USD 2,300 |
Higher due to newer, single-tablet regimen |
Pricing Trends
- Slight decline in price as generic versions emerge.
- Gilead maintains premium pricing due to brand strength and patent exclusivity.
- Discount programs like Gilead's Copay Assistance reduce patient out-of-pocket, influencing pharmacy procurement costs.
Patent & Regulatory Considerations
- Gilead's exclusivity for Descovy initially extended until 2024.
- Recent patent challenges and legal rulings are expected to open the market to generics by 2024-2026.
- Pricing could decline 20-40% post-patent expiry, aligning with generic competition levels observed in similar drugs.
Future Market and Price Projections
Market Growth Drivers
- Continued clinical adoption for PrEP in high-risk populations.
- Potential label expansions to include additional indications.
- Growing awareness and insurance coverage promoting uptake.
Price Projections (Next 3-5 years)
| Year |
Price Range (USD) |
Comment |
| 2023 |
USD 2,000-2,200 |
Reflects current pricing with slight inflation |
| 2024 |
USD 1,600-1,900 |
Anticipate price drops with generic entry |
| 2025 |
USD 1,200-1,600 |
Generic competition establishes market norms |
| 2026 |
USD 1,000-1,300 |
Dominant generics to dominate |
Impact Factors
- Entry of generics expected to reduce prices by approximately 30-50%.
- Price erosion will depend on market penetration of competitors and insurance reimbursement policies.
- Manufacturer strategies may include volume discounts, licensing agreements, and patient assistance programs.
Regulatory & Market Risks
- Delays or adverse outcomes in patent litigation could accelerate price reductions.
- New clinical data or label expansions may influence market share and pricing.
- Regulatory rejections or issues could impact future sales forecasts.
Key Takeaways
- Descovy remains a leading HIV treatment with high annual sales, supported by a broadening PrEP market.
- Current prices are stable, but generic entry from 2024 onwards will exert downward pressure.
- Price declines are expected to mirror trends observed in similar antiviral drugs post-patent expiry.
- Market expansion into new indications and increased adoption for PrEP will support volume growth despite price erosion.
- Competitive dynamics and legal developments will be key determinants of future pricing.
FAQs
Q1: When will generic versions of NDC 64980-0513 become available?
A: Patent challenges could lead to generics entering the market between 2024 and 2026.
Q2: How does Descovy compare in price to Truvada?
A: Descovy's current AWP is about USD 2,100 per month, whereas Truvada averages USD 1,700. Price differences are influenced by formulation and patent status.
Q3: What factors could influence Descovy’s market share in the future?
A: Patent expiration, clinical trial outcomes, label expansion, insurance reimbursement policies, and competing products.
Q4: What is the potential impact of increased PrEP adoption on pricing?
A: Higher demand for PrEP could sustain revenues despite potential price reductions due to increased volume.
Q5: How do Gilead’s pricing strategies and patient assistance programs influence market dynamics?
A: These programs help maintain market penetration by reducing patient out-of-pocket costs, mitigating some effects of price declines on total revenue.
References
- FDA. (2016). FDA approves Descovy for HIV treatment. Retrieved from https://www.fda.gov/
- Gilead Sciences. (2022). Annual Financial Report.
- IQVIA. (2022). United States prescription drug market statistics.
- Statista. (2023). Global HIV antiviral market size.
- Medscape. (2022). HIV treatment market trends.
