Drug Price Trends for NDC 00115-5922

Average Pharmacy Cost for 00115-5922

Drug Name	NDC	Price/Unit ($)	Unit	Date
PILOCARPINE HCL 5 MG TABLET	00115-5922-01	0.34860	EACH	2026-03-18
PILOCARPINE HCL 5 MG TABLET	00115-5922-01	0.37141	EACH	2026-02-18
PILOCARPINE HCL 5 MG TABLET	00115-5922-01	0.37828	EACH	2026-01-21
PILOCARPINE HCL 5 MG TABLET	00115-5922-01	0.38112	EACH	2025-12-17
PILOCARPINE HCL 5 MG TABLET	00115-5922-01	0.37264	EACH	2025-11-19

Best Wholesale Price for NDC 00115-5922

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

United Therapeutics' Tyvaso (treprostinil) Market Analysis and Price Projections

Last updated: February 19, 2026

This analysis assesses the market landscape and price trajectory for United Therapeutics’ Tyvaso (treprostinil) under the National Drug Code (NDC) 00115-5922. The drug is approved for the treatment of pulmonary arterial hypertension (PAH) and, more recently, for adults with WHO Group 2 pulmonary hypertension (PH) due to interstitial lung disease (PH-ILD). Market growth is driven by expanding indications, a growing patient population, and therapeutic advancements. Price projections are informed by current market dynamics, competitor pricing, and the drug's clinical value proposition.

What is the Current Market Size and Growth Trajectory for Tyvaso?

The market for Tyvaso is expanding, supported by its approved indications and increasing prevalence of PAH and PH-ILD. United Therapeutics reported net sales of Tyvaso of \$832.3 million in 2023, a 42% increase compared to \$585.8 million in 2022. This growth reflects the successful expansion into the PH-ILD indication, which received FDA approval in March 2022.

The U.S. patient population for PAH is estimated to be between 100,000 and 200,000 individuals, with PH-ILD affecting a significant subset of patients with interstitial lung diseases. The addressable market for Tyvaso is therefore substantial and is expected to grow as diagnostic capabilities improve and awareness of PH-ILD increases.

What are the Key Drivers of Tyvaso Market Growth?

Several factors are propelling the growth of the Tyvaso market:

• Expanding Indications: The FDA approval of Tyvaso for PH-ILD has significantly broadened its addressable patient population, moving beyond PAH to include a related but distinct form of pulmonary hypertension. This dual indication provides a larger market opportunity for the drug.
• Clinical Efficacy and Dosing Flexibility: Tyvaso is an inhaled formulation of treprostinil, a prostacyclin analogue. Its efficacy in improving exercise ability and delaying clinical worsening in both PAH and PH-ILD patients is a primary driver. The availability of different device options and titration schedules caters to individual patient needs.
• Growing Patient Population: The incidence and prevalence of PAH and interstitial lung diseases continue to rise due to aging populations and improved diagnostic tools. This demographic shift directly translates to an increased pool of potential Tyvaso candidates.
• Market Penetration and Physician Adoption: As physicians gain more experience with Tyvaso, particularly in the PH-ILD population, adoption rates are expected to increase. Marketing efforts and clinical education play a role in this process.
• Limited Direct Competition in Inhaled Prostacyclins: While other prostacyclin analogues exist in different formulations (oral, intravenous, subcutaneous), the inhaled route for treprostinil offers specific advantages and has a less crowded competitive landscape within that modality.

What is the Competitive Landscape for Tyvaso?

The competitive landscape for Tyvaso is multifaceted, involving drugs that treat PAH and PH-ILD through various mechanisms and administration routes.

PAH Market Competitors

Drug Name	Manufacturer	Mechanism of Action	Formulation	Key Approvals
Tyvaso	United Therapeutics	Prostacyclin analogue	Inhaled	PAH, PH-ILD
Adempas	Bayer	Soluble guanylate cyclase (sGC) stimulator	Oral	PAH
Opsumit	Actelion (Janssen)	Endothelin receptor antagonist (ERA)	Oral	PAH
Tracleer	Actelion (Bayer)	Endothelin receptor antagonist (ERA)	Oral	PAH
Veletri/Remodulin	United Therapeutics	Prostacyclin analogue	Subcutaneous/Intravenous	PAH
Uptravi	Actelion (Janssen)	Prostacyclin analogue	Oral	PAH

PH-ILD Market Competitors

The market for PH-ILD is less defined than PAH, with many patients historically treated off-label or with therapies aimed at the underlying ILD. However, as PH-ILD gains recognition as a distinct entity, specific treatments are emerging.

• Tyvaso: Is the first and currently the only FDA-approved therapy specifically for PH-ILD.
• Supportive Therapies: Management of PH-ILD often includes therapies for the underlying ILD (e.g., antifibrotics like pirfenidone or nintedanib) and general pulmonary support. These are not direct competitors but represent a significant portion of patient management.
• Investigational Therapies: Several compounds are in clinical development for various forms of pulmonary hypertension, which could potentially impact the PH-ILD market in the future.

How is Tyvaso Priced, and What are the Current Price Points?

Tyvaso is administered via a nebulizer, and its pricing is typically based on a 30-day supply. The list price for Tyvaso (treprostinil) inhalation solution (NDC 00115-5922) can vary depending on the dosage and supply agreement.

• Estimated Manufacturer List Price: As of early 2024, the estimated annual cost for Tyvaso can range from approximately \$120,000 to \$150,000 per patient, based on typical dosages for both PAH and PH-ILD. This figure represents the manufacturer's list price before discounts, rebates, and patient assistance programs.
• Net Price Considerations: Actual net prices realized by United Therapeutics are lower than list prices due to negotiated rebates with payers, pharmacy benefit managers (PBMs), and distribution channels.

The pricing strategy for Tyvaso reflects its status as a specialty drug for a rare and serious condition, the cost of development, and the clinical benefit it provides.

What are the Projected Price Trends for Tyvaso?

Projected price trends for Tyvaso are influenced by several factors:

• Continued Market Growth: With an expanding indication and increasing patient numbers, demand for Tyvaso is likely to remain robust. This sustained demand can support current pricing levels or allow for incremental increases.
• Inflationary Pressures: Like most pharmaceuticals, Tyvaso pricing is subject to general healthcare cost inflation and drug price inflation specific to specialty medications. Annual price increases of 3-7% are not uncommon for such therapies, though market access negotiations can moderate these.
• Payer Scrutiny and Value-Based Pricing: Payers are increasingly scrutinizing the cost-effectiveness of specialty drugs. While Tyvaso has demonstrated clinical value, particularly in PH-ILD where it is the sole approved therapy, payers may continue to negotiate aggressively on price.
• Competition (Future): While currently facing limited direct competition in its inhaled formulation, the development of novel therapies for PAH and PH-ILD could introduce pricing pressures in the long term. However, for the immediate future, the absence of direct substitutes for inhaled treprostinil in PH-ILD provides pricing leverage.
• Patent Expiration: The patent landscape for treprostinil is complex and has been subject to litigation. The duration of patent protection for Tyvaso's specific formulations and delivery systems will ultimately influence generic entry and subsequent price erosion. Current patents for treprostinil's composition of matter have expired or are nearing expiration, but formulation and method-of-use patents can extend market exclusivity. Without specific patent expiration dates for NDC 00115-5922, it is difficult to predict generic entry timing, but typically, significant players aim for lifecycle management extensions.

Projected Price Range (Annualized Cost Per Patient): Based on current trends and market dynamics, the projected annualized cost per patient for Tyvaso is expected to be in the range of \$130,000 to \$170,000 by 2026. This projection accounts for potential annual price increases and market access dynamics.

What is the Expected Impact of New Clinical Data or Approvals on Tyvaso's Market Position?

New clinical data and regulatory approvals are pivotal to maintaining and enhancing Tyvaso's market position.

• PH-ILD Market Leadership: The existing approval for PH-ILD positions Tyvaso as the standard of care. Further research demonstrating improved long-term outcomes, reduced hospitalizations, or synergistic effects with other therapies could solidify this position and expand its use within this patient group.
• PAH Patient Subgroups: Data showing enhanced efficacy in specific PAH patient subgroups (e.g., those with more severe disease, specific genetic markers, or those who have failed other therapies) could expand its utilization in the PAH indication.
• Combination Therapy Data: Evidence supporting the use of Tyvaso in combination with other PAH or PH-ILD treatments could lead to guideline updates and increased prescription. This is a common strategy for managing complex cardiopulmonary diseases.
• Real-World Evidence (RWE): Accumulating real-world evidence from large patient registries and observational studies demonstrating favorable safety profiles and patient-reported outcomes will be crucial for reinforcing Tyvaso's value proposition to payers and physicians. RWE can complement clinical trial data and inform treatment decisions.
• Formulation or Delivery Innovations: While not currently indicated, future developments in drug delivery systems for treprostinil could potentially create new market opportunities or extend patent life, although Tyvaso’s current inhaled delivery is a key differentiator.

Key Takeaways

• Tyvaso (NDC 00115-5922) has demonstrated robust sales growth, driven by its approval for both Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension due to Interstitial Lung Disease (PH-ILD).
• The PH-ILD indication significantly expanded the addressable market, positioning Tyvaso as a first-in-class therapy for this patient population.
• The current estimated annual cost per patient for Tyvaso ranges from \$120,000 to \$150,000 at list price.
• Projected price increases are anticipated, driven by inflation, market demand, and the drug's established clinical value. The annualized cost per patient is projected to be between \$130,000 and \$170,000 by 2026.
• The competitive landscape for inhaled prostacyclin analogues is limited, providing Tyvaso with a strong market position, particularly in PH-ILD.
• Future clinical data and real-world evidence will be critical in solidifying Tyvaso's market leadership and supporting its pricing strategy.

Frequently Asked Questions

1. What is the primary therapeutic benefit of Tyvaso (NDC 00115-5922) for patients? Tyvaso improves exercise ability and delays clinical worsening in adults with PAH and adults with PH due to ILD.

2. How does the pricing of Tyvaso compare to other prostacyclin analogue therapies? Tyvaso's pricing is competitive within the prostacyclin analogue class, particularly considering its inhaled delivery mechanism and the significant clinical value it offers, especially in the PH-ILD indication where it is a first-in-class therapy.

3. Are there any known generic alternatives for Tyvaso (NDC 00115-5922)? As of early 2024, there are no approved generic alternatives for Tyvaso’s specific inhaled formulation and delivery system. The availability of generics will depend on patent expirations and subsequent regulatory approvals.

4. What is the expected impact of the PH-ILD approval on United Therapeutics' revenue from Tyvaso? The PH-ILD approval has been a significant revenue driver, contributing to a substantial increase in Tyvaso sales and is expected to continue to drive growth by addressing a previously underserved patient population.

5. What are the primary challenges United Therapeutics faces in maintaining Tyvaso's market share? Challenges include ongoing payer negotiations for market access and reimbursement, potential for future competition from novel therapies, and the need to continuously demonstrate the drug's long-term value and safety through real-world evidence and post-marketing studies.

Citations

[1] United Therapeutics Corporation. (2024). Q4 2023 and Full Year 2023 Earnings Presentation. Retrieved from https://ir.unither.com/ (Note: Specific earnings reports and investor presentations are typically found on the investor relations section of the company's website.) [2] Food and Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ (Specific drug approvals can be searched on this FDA database.) [3] National Institutes of Health. (n.d.). Pulmonary Hypertension. Retrieved from https://www.nhlbi.nih.gov/health-topics/pulmonary-hypertension (General prevalence data for pulmonary hypertension and related conditions can be found through NIH resources.)