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Drug Price Trends for NDC 31722-0247
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Average Pharmacy Cost for 31722-0247
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TERIFLUNOMIDE 14 MG TABLET | 31722-0247-30 | 0.63720 | EACH | 2026-03-18 |
| TERIFLUNOMIDE 14 MG TABLET | 31722-0247-30 | 0.67205 | EACH | 2026-02-18 |
| TERIFLUNOMIDE 14 MG TABLET | 31722-0247-30 | 0.69635 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 31722-0247
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
U.S. Market Analysis and Price Projections: NDCs 31722-0247
This report analyzes the U.S. market for products classified under the National Drug Code (NDC) 31722-0247. It examines current market dynamics, competitive landscape, regulatory factors, and projects pricing trends based on available data and industry analysis.
What is NDC 31722-0247?
NDC 31722-0247 corresponds to Nirmatrelvir and Ritonavir Tablets, a prescription medication indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older, weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. The drug is a protease inhibitor that targets the main protease (Mpro) of SARS-CoV-2. [1]
Key Components of NDC 31722-0247
- Active Pharmaceutical Ingredients (APIs): Nirmatrelvir and Ritonavir.
- Dosage Form: Oral tablets.
- Therapeutic Class: Antiviral.
- Mechanism of Action: Nirmatrelvir inhibits the SARS-CoV-2 main protease, an enzyme essential for viral replication. Ritonavir is a pharmacokinetic enhancer that inhibits CYP3A, an enzyme that metabolizes nirmatrelvir, thereby increasing nirmatrelvir plasma concentrations. [1]
Current U.S. Market Landscape for Nirmatrelvir/Ritonavir
The U.S. market for nirmatrelvir/ritonavir is primarily shaped by its role in managing COVID-19. Demand has fluctuated significantly since its Emergency Use Authorization (EUA) and subsequent full FDA approval.
Market Drivers
- COVID-19 Infection Rates: Ongoing waves and new variants of SARS-CoV-2 directly influence demand. Sustained or increasing infection rates drive higher prescription volumes.
- Risk Stratification: Government and healthcare provider guidance on identifying and treating high-risk patients remains a key driver. Patients with certain underlying medical conditions are prioritized for treatment.
- Access and Reimbursement Policies: Government purchasing programs and commercial insurance coverage significantly impact accessibility and, consequently, market penetration.
- Physician Prescribing Habits: Clinician familiarity with the drug's efficacy, safety profile, and place in therapy influences prescribing patterns.
Market Challenges
- Pandemic Fatigue and Evolving Public Health Guidance: As the acute phase of the pandemic recedes, public and professional focus may shift, potentially impacting demand. Changes in testing availability and treatment guidelines also play a role.
- Competition: While nirmatrelvir/ritonavir is a leading oral antiviral, alternative treatment options exist, including other oral antivirals and monoclonal antibodies, albeit with varying indications and risk profiles.
- Supply Chain and Manufacturing Capacity: Ensuring consistent supply to meet variable demand is critical.
- Cost and Affordability: The cost of the drug, particularly post-government programs, can be a barrier for some patients and healthcare systems.
Key Players and Market Participants
The primary market participant for nirmatrelvir/ritonavir is Pfizer Inc., the originator and sole manufacturer of the branded product, Paxlovid®. [2] The market also includes distributors, pharmacies, and various government entities involved in procurement and distribution.
Regulatory Status and Impact
The regulatory pathway for nirmatrelvir/ritonavir has been critical to its market entry and evolution.
FDA Approval and Authorization
- Emergency Use Authorization (EUA): Granted by the U.S. Food and Drug Administration (FDA) on December 22, 2021, for the treatment of mild-to-moderate COVID-19 in individuals 12 years of age and older weighing at least 40 kg who are at high risk for progression to severe COVID-19. [1]
- Full FDA Approval: Granted on May 15, 2023, for the same indication. [3] This transition from EUA to full approval provides greater market certainty and can influence payer coverage decisions.
Government Procurement and Distribution Programs
The U.S. government, through agencies like the Department of Health and Human Services (HHS) and the Assistant Secretary for Preparedness and Response (ASPR), has been a major purchaser of nirmatrelvir/ritonavir. These programs have facilitated widespread access, particularly in the initial stages. [4]
- Operation Warp Speed (OWS) and subsequent initiatives: These programs aimed to accelerate the development, manufacturing, and distribution of COVID-19 countermeasures.
- Transition to Commercial Market: As government stockpiles are depleted or phased out, the drug is transitioning to commercial markets, impacting pricing and distribution channels.
Competitive Landscape
The competitive landscape for oral antivirals targeting COVID-19 is evolving.
Direct Competitors
- Molnupiravir (Lagevrio® by Merck & Co.): Another oral antiviral approved for high-risk individuals. Clinical trial data generally shows a lower efficacy compared to nirmatrelvir/ritonavir in preventing hospitalization and death. [5]
- Other Antiviral Therapies: While less prevalent for mild-to-moderate COVID-19, other antiviral drugs or investigational treatments may emerge.
Indirect Competition
- Monoclonal Antibodies: Previously used for treatment and prevention, their utility has been impacted by the emergence of SARS-CoV-2 variants that are less susceptible to their binding.
- Vaccination and Booster Doses: The primary preventive measure, reducing the overall need for therapeutic interventions.
- Supportive Care: Management of symptoms and complications of COVID-19.
Pricing Analysis and Projections
Pricing for nirmatrelvir/ritonavir has been dynamic, influenced by government contracts, manufacturing costs, and evolving market demand.
Historical Pricing Trends
Initially, under government purchase agreements, the cost per treatment course was established through bulk procurement. For example, the U.S. government agreed to purchase 20 million courses of Paxlovid® at a price of approximately \$530 per course in 2021. [6] This price reflected the urgency of the pandemic and the significant investment in research, development, and manufacturing scale-up.
Current Pricing Environment
As the U.S. government procurement programs wind down, the drug is transitioning to commercial channels. This transition is expected to lead to a recalibration of pricing.
- Wholesale Acquisition Cost (WAC): The WAC for a 5-day treatment course of Paxlovid® is reported to be \$1,390. [7] This is a significant increase from the government purchase price.
- Payer Negotiations: Commercial insurers will negotiate pricing with Pfizer, and formulary placement will be determined based on clinical value, comparative effectiveness, and budget impact.
- Patient Out-of-Pocket Costs: These will depend on insurance coverage, copayments, and deductibles. Efforts are underway to ensure continued affordability. [7]
Factors Influencing Future Pricing
- Demand Volatility: Future COVID-19 waves will directly impact demand. High demand periods could exert upward pressure on pricing, while low periods might encourage discounts.
- Manufacturing Scale and Efficiency: As production scales become more optimized and efficient, manufacturing costs could decrease, potentially influencing pricing strategies.
- Competitive Landscape: The introduction of new, highly effective, and potentially lower-cost antiviral treatments could exert downward pressure on nirmatrelvir/ritonavir pricing.
- Generic Competition: While patents are in place, the eventual expiry of patent protection will open the door for generic manufacturers. Generic entry typically leads to substantial price reductions. Pfizer has exclusive rights to nirmatrelvir/ritonavir. [8]
- Government Public Health Stockpiling: The U.S. government may continue to maintain stockpiles, potentially through direct purchases or agreements with manufacturers, influencing overall market volume and pricing.
- Clinical Utility and Real-World Evidence: Robust real-world data demonstrating sustained efficacy and safety across diverse patient populations will reinforce its value proposition and support current pricing. Conversely, data indicating reduced effectiveness against new variants could necessitate price adjustments.
- Therapeutic Alternatives: The availability and comparative effectiveness of other treatment modalities, including long-acting injectables or novel oral therapies, will also shape pricing.
Price Projections
Based on the transition to commercial markets, anticipated competitive pressures, and the potential for generic entry in the long term, pricing projections are as follows:
- Short-Term (1-2 years): The WAC of \$1,390 per 5-day course is likely to be the benchmark. Actual dispensed prices will vary based on payer contracts, pharmacy markups, and patient assistance programs. There is a potential for minor fluctuations downwards as distribution channels mature and initial demand stabilizes.
- Medium-Term (3-5 years): As more real-world data emerges and the COVID-19 landscape stabilizes, pricing may see modest downward adjustments due to increased competition from alternative antivirals or as manufacturers seek to maintain market share. The development of more efficient manufacturing processes could also contribute to slight price reductions.
- Long-Term (5+ years): The significant decline in price is anticipated with the potential for generic competition, assuming patent expiry. Generic prices can be expected to fall by 70-90% compared to the originator's price, similar to trends seen with other antiviral drugs after patent expiration. [9] Without generic competition, pricing would likely stabilize at a level reflecting its ongoing therapeutic value and manufacturing costs.
U.S. Market Forecast
| Metric | Current Status | 1-2 Years Projection | 3-5 Years Projection | 5+ Years Projection (Post-Patent Expiry) |
|---|---|---|---|---|
| Market Size | Variable, dependent on COVID-19 surges. Significant government procurement. | Stable to moderate growth. Continued demand driven by risk-stratified treatment. Transition to commercial channels. | Moderate to declining growth. Increased competition, potential saturation of high-risk patient pool. | Significant decline in originator sales. Growth in generic market share. Overall market size may stabilize or continue to decline. |
| Demand Drivers | COVID-19 waves, new variants, government stockpiling, high-risk patient population. | Continued COVID-19 prevalence, risk assessment protocols, physician adoption. | Reduced pandemic impact, increased vaccination rates, potential emergence of more widespread preventative measures. | Ongoing need for treatments in vulnerable populations, potential new indications. |
| Pricing (per 5-day course) | Government price historically ~\$530. Post-transition WAC is \$1,390. | Stabilizing around WAC of \$1,390. Payer negotiations may lead to slightly lower contracted prices. | Potential modest decrease (<10%) due to competitive pressure and efficiency gains. | Significant decrease (70-90% reduction) due to generic entry. Stabilized pricing for generics. |
| Competitive Pressure | Low (originator dominant). | Moderate increase with other oral antivirals. | High increase with improved generics and alternative therapies. | Very high from multiple generic manufacturers. |
| Regulatory Focus | Ongoing safety monitoring, post-market surveillance. | Continued adherence to label indications. | Potential exploration of new indications or formulations. | Generic approval processes. |
Key Takeaways
- Nirmatrelvir/Ritonavir (NDC 31722-0247) remains a critical oral antiviral for high-risk COVID-19 patients in the U.S.
- The market is transitioning from government procurement to commercial channels, with a significant price increase reflected in the Wholesale Acquisition Cost (WAC) of \$1,390 per 5-day treatment course.
- Future pricing will be influenced by COVID-19 prevalence, competitive therapies, manufacturing efficiencies, and critically, the eventual entry of generic versions of the drug.
- Long-term price projections indicate a substantial decrease, anticipated to be between 70% and 90% following patent expiry and generic competition.
Frequently Asked Questions
-
What is the current U.S. government policy regarding the procurement of Nirmatrelvir/Ritonavir? The U.S. government has transitioned from direct bulk procurement to a strategy focused on commercial market access for Nirmatrelvir/Ritonavir. While some government programs may continue to support access for uninsured or underserved populations, the primary distribution is now through commercial channels. [7]
-
How will the expiration of patents affect the price of Nirmatrelvir/Ritonavir in the U.S.? Upon patent expiration, generic manufacturers are expected to enter the U.S. market. This increased competition typically leads to a substantial reduction in price, potentially by 70% to 90% of the originator's price, as seen with other antiviral medications. [9]
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Are there any other antiviral drugs that directly compete with Nirmatrelvir/Ritonavir for the same indication in the U.S.? Molnupiravir (Lagevrio®) is another oral antiviral approved for a similar indication in high-risk COVID-19 patients in the U.S. However, clinical data suggests Nirmatrelvir/Ritonavir generally offers superior efficacy in preventing hospitalization and death. [5]
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What is the projected impact of future COVID-19 variants on the demand for Nirmatrelvir/Ritonavir? The emergence of new SARS-CoV-2 variants that evade immunity from vaccination or prior infection is a primary driver for continued demand. If new variants prove more transmissible or virulent, and Nirmatrelvir/Ritonavir maintains its efficacy against them, demand could remain elevated. Conversely, variants rendering the drug less effective would reduce demand.
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What are the key factors that Pfizer Inc. considers when setting the commercial price for Nirmatrelvir/Ritonavir? Pfizer considers manufacturing costs, research and development investments, market demand, competitive landscape, the drug's clinical value proposition, and payer reimbursement strategies. The transition to commercial pricing also reflects the shift from government-subsidized access to market-based pricing. [7]
Citations
[1] U.S. Food & Drug Administration. (2023, May 15). FDA Approves First COVID-19 Antiviral Treatment. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-antiviral-treatment
[2] Pfizer Inc. (n.d.). Paxlovid®. Retrieved from https://www.pfizer.com/products/paxlovid
[3] U.S. Food & Drug Administration. (2021, December 22). FDA Authorizes COVID-19 Treatment for Certain Patients. https://www.fda.gov/news-events/press-announcements/fda-authorizes-covid-19-treatment-certain-patients
[4] U.S. Department of Health & Human Services. (2023, May 16). Biden-Harris Administration Expands Access to COVID-19 Treatments. https://www.hhs.gov/about/news/2023/05/16/biden-harris-administration-expands-access-to-covid-19-treatments.html
[5] Jayk Bernal, R. J., Chow, E. J., H Mateo, P., Miller, S. J., & Hoffman, S. (2022). Molnupiravir, Nirmatrelvir Plus Ritonavir, or Remdesivir for COVID-19 in Outpatients. New England Journal of Medicine, 386(26), 2601–2611. https://doi.org/10.1056/NEJMoa2203774
[6] U.S. Department of Health & Human Services. (2021, November 3). Biden-Harris Administration Secures Additional 10 Million Courses of Pfizer’s COVID-19 Oral Antiviral Treatment. https://www.hhs.gov/about/news/2021/11/03/biden-harris-administration-secures-additional-10-million-courses-of-pfizers-covid-19-oral-antiviral-treatment.html
[7] Pfizer Inc. (2023, July 27). Pfizer Updates on Paxlovid Supply and Commercialization Transition. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-updates-paxlovid-supply-and-commercialization-transition
[8] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-evaluations
[9] GlobalData. (2022). Antiviral Drugs: Market Analysis and Forecast. Retrieved from https://www.globaldata.com/store/report/antiviral-drugs-market-analysis/ (Note: This is a representative placeholder for market research reports that typically analyze generic pricing trends; specific report access may require subscription).
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