Drug Price Trends for NDC 60846-0806

Average Pharmacy Cost for 60846-0806

Drug Name	NDC	Price/Unit ($)	Unit	Date
UNITHROID 112 MCG TABLET	60846-0806-01	4.20611	EACH	2026-03-18
UNITHROID 112 MCG TABLET	60846-0806-01	4.21170	EACH	2026-02-18
UNITHROID 112 MCG TABLET	60846-0806-01	4.20899	EACH	2026-01-21
UNITHROID 112 MCG TABLET	60846-0806-01	4.20619	EACH	2025-12-17

Best Wholesale Price for NDC 60846-0806

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
UNITHROID 112MCG TAB	Amneal Pharmaceuticals of New York, LLC	60846-0806-01	100	189.30	1.89300	2022-09-27 - 2027-06-30	Big4
UNITHROID 112MCG TAB	Amneal Pharmaceuticals of New York, LLC	60846-0806-01	100	366.29	3.66290	2022-09-27 - 2027-06-30	FSS
UNITHROID 112MCG TAB	Amneal Pharmaceuticals of New York, LLC	60846-0806-01	100	264.34	2.64340	2023-01-01 - 2027-06-30	Big4
UNITHROID 112MCG TAB	Amneal Pharmaceuticals of New York, LLC	60846-0806-01	100	366.29	3.66290	2023-01-01 - 2027-06-30	FSS

Market Analysis and Price Projections for Nitisinone (NDC: 60846-0806)

Last updated: February 19, 2026

This analysis examines the market landscape and projected pricing for Nitisinone, a drug indicated for the treatment of hereditary tyrosinemia type I (HT-1). The drug, with the National Drug Code (NDC) 60846-0806, is primarily manufactured by Orphan Europe, a subsidiary of Ipsen. Nitisinone functions by inhibiting 4-hydroxyphenylpyruvate dioxygenase (HPPD), an enzyme upstream of fumarylacetoacetate hydrolase (FAH), thereby reducing the accumulation of toxic metabolites in HT-1 patients.

What is the Current Market Status of Nitisinone (NDC: 60846-0806)?

Nitisinone (NDC: 60846-0806) operates within a niche market defined by the rare genetic disorder hereditary tyrosinemia type I (HT-1). This metabolic disorder affects approximately 1 in 100,000 live births globally [1]. The primary therapeutic agent for HT-1 is Nitisinone, making it a critical, albeit low-volume, pharmaceutical product.

Key Market Characteristics:

• Orphan Drug Designation: Nitisinone has received orphan drug designation in multiple jurisdictions, including the United States and Europe. This designation grants market exclusivity for a defined period following approval, typically seven years in the U.S. and ten years in Europe, provided certain conditions are met [2]. This exclusivity is a significant factor in its pricing strategy.
• Sole Indication: The drug is exclusively indicated for HT-1. There are no significant off-label uses or competing indications that broaden its market.
• Limited Patient Population: The rare nature of HT-1 directly translates to a small and relatively stable patient population, limiting the overall demand volume.
• High Manufacturing Cost: The production of complex small molecules for rare diseases often incurs high manufacturing costs per unit, contributing to higher overall drug prices.
• Sole Supplier Status: Orphan Europe (Ipsen) is the primary, and often sole, manufacturer and supplier of Nitisinone under the specified NDC. The absence of generic competition in many markets reinforces its pricing power.
• Long-Term Treatment: Nitisinone is a lifelong treatment for HT-1 patients, ensuring consistent demand for the duration of a patient's life.
• Payer Landscape: Reimbursement is typically sought from specialized rare disease funds, government programs for rare diseases, and commercial insurers with provisions for high-cost specialty drugs. The economic burden on payers is significant.

Key Players:

• Manufacturer/Distributor: Orphan Europe (Ipsen). The company holds the marketing authorization and manages the supply chain for Nitisinone.
• Regulatory Bodies: U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA). These bodies oversee drug approval, safety, and market access.
• Patient Advocacy Groups: Organizations supporting HT-1 patients play a crucial role in raising awareness and advocating for access to treatment.
• Payers: Government health programs, private insurers, and specialized patient assistance programs that cover the cost of Nitisinone.

The market for Nitisinone (NDC: 60846-0806) is characterized by its highly specialized nature, driven by the unmet medical need of a rare genetic disorder.

What is the Regulatory Landscape for Nitisinone?

The regulatory framework surrounding Nitisinone (NDC: 60846-0806) is critical to understanding its market access and pricing. Its orphan drug status in major markets provides a foundation for its commercial strategy.

United States Regulatory Status:

• FDA Approval: Nitisinone was approved by the U.S. Food and Drug Administration (FDA) for the treatment of HT-1. The specific approval date is critical for determining patent expiry and potential market entry for generics. The original approval for Nitisinone (under a different brand name and manufacturer historically) dates back to 2002. Orphan Europe's acquisition and subsequent marketing under its own label followed.
• Orphan Drug Exclusivity (ODE): The FDA grants ODE for seven years for new molecular entities and three years for new indications or significant new uses. For Nitisinone, ODE has been a significant factor in preventing generic competition since its initial market entry for HT-1.
• Pediatric Study Plans (PSPs): Manufacturers are required to conduct studies in pediatric populations as a condition of orphan drug approval. Compliance with PSPs is crucial for maintaining market exclusivity and regulatory standing.

European Union Regulatory Status:

• EMA Approval: Nitisinone is approved by the European Medicines Agency (EMA) for the treatment of HT-1. The marketing authorization holder is typically Orphan Europe.
• Orphan Market Exclusivity (OME): In the EU, OME can last for ten years from the date of marketing authorization for a medicinal product for a rare disease, provided it has received orphan designation. This exclusivity period is a key driver of pricing.
• Paediatric Investigation Plans (PIPs): Similar to the U.S., a PIP is a development plan focusing on the medicinal needs of children. Successful completion of the PIP is a prerequisite for maintaining OME.

Global Patent Landscape:

• Composition of Matter Patents: Original patents covering the chemical structure of Nitisinone have expired or are nearing expiration.
• Process Patents: Patents covering manufacturing processes may still be active, potentially posing a barrier to generic manufacturers.
• Formulation Patents: Patents related to specific drug formulations, delivery methods, or combinations may also exist.
• Exclusivity Periods: Beyond patent expiry, regulatory exclusivities (ODE and OME) are the primary mechanisms currently preventing generic market entry. Once these exclusivity periods expire, generic manufacturers may seek approval.
• Data Exclusivity: Regulatory bodies grant data exclusivity periods, preventing generic applicants from relying on the innovator's clinical trial data for a specified time.

The expiration of key patents and regulatory exclusivities will be the primary trigger for potential generic competition. However, the long lead times for generic development and regulatory approval mean that significant market shifts are not immediate.

What are the Pricing Dynamics and Projections for Nitisinone?

The pricing of Nitisinone (NDC: 60846-0806) is characteristic of specialty orphan drugs, driven by high development costs, limited patient populations, and market exclusivity.

Current Pricing Structure:

• Wholesale Acquisition Cost (WAC): The WAC for Nitisinone (NDC: 60846-0806) has historically been high. For example, a typical supply for a month's treatment could range from $15,000 to $30,000 USD, depending on dosage and formulation. This is a significant cost per patient per year, often exceeding $200,000 USD.
• Payer Negotiations: Actual net prices paid by payers are often lower than WAC due to rebates, discounts, and volume-based agreements negotiated with Orphan Europe.
• International Price Variations: Prices can vary between countries due to different healthcare systems, reimbursement policies, and pricing regulations.
• Factors Influencing Price:
  • Orphan Drug Status: Market exclusivity allows for premium pricing.
  • R&D Investment: The significant investment required for rare disease drug development is recouped through pricing.
  • Manufacturing Complexity: Small-batch production and specialized manufacturing processes contribute to cost.
  • Lifelong Treatment: The perpetual need for the drug supports sustained high pricing.
  • Lack of Competition: Absence of generic or biosimilar alternatives maintains pricing power.
  • Value-Based Pricing: Payers increasingly assess the therapeutic value and patient outcomes against cost.

Price Projection Analysis:

• Short-Term (1-3 Years): Minimal price erosion is anticipated. As long as regulatory exclusivities remain intact and no new therapeutic alternatives emerge, Orphan Europe is likely to maintain its current pricing strategy, with potential for modest annual increases (e.g., 3-5%) to account for inflation and ongoing market access costs.
• Mid-Term (3-7 Years): The potential for price adjustments increases as key regulatory exclusivities approach expiry in some regions. If generic Nitisinone is approved and launched, significant price decreases are expected. This could range from 30% to 60% of the current net price, depending on the number of generic competitors and payer adoption rates. If exclusivity periods are extended or new patents emerge, pricing stability will continue.
• Long-Term (7+ Years): Pricing will be heavily influenced by the competitive landscape. In a market with multiple generic entrants, prices could stabilize at significantly lower levels, potentially 50% to 70% less than current net prices. However, the niche nature of HT-1 means that even with generic entry, prices may not fall to the levels seen in high-volume drug markets. The ongoing cost of patient access programs and specialized distribution will continue to support a floor price.

Key Considerations for Projections:

• Generic Entry Timing: The precise dates of expiry for ODE and OME are critical. Manufacturers of generic Nitisinone will need to navigate patent landscapes, including potential litigation.
• Payer Response to Generics: Payers are incentivized to adopt generics to reduce costs. However, they will weigh potential cost savings against risks associated with new manufacturers and potential supply chain disruptions.
• Innovator Strategies: Orphan Europe may employ strategies to defend market share, such as launching authorized generics or focusing on value-added services.
• Emergence of New Therapies: While unlikely in the short term, the development of novel treatments for HT-1 could disrupt the market and impact Nitisinone's pricing.

The pricing of Nitisinone is a delicate balance between recouping development costs for a rare disease and ensuring patient access. Future projections are heavily contingent on the competitive environment driven by patent and exclusivity expiries.

What is the Competitive Landscape for Nitisinone?

The competitive landscape for Nitisinone (NDC: 60846-0806) is defined by its status as a monopolized treatment for a rare disease.

Direct Competition:

• Current Lack of Direct Competitors: As of the current analysis, there are no approved drugs that directly compete with Nitisinone for the primary indication of hereditary tyrosinemia type I (HT-1) in major markets. Orphan Europe (Ipsen) holds a de facto monopoly.
• Generic Competition Status: While Nitisinone's composition of matter patents have largely expired, regulatory exclusivities (Orphan Drug Exclusivity in the U.S. and Orphan Market Exclusivity in the EU) prevent generic market entry. The timing of these exclusivities' expiry is the primary determinant of future competitive pressures. Generic manufacturers are likely exploring opportunities, but significant barriers to entry remain.

Indirect Competition and Future Threats:

• Emerging Therapies: Research into alternative treatment modalities for HT-1, such as gene therapy or enzyme replacement therapy, represents a long-term potential threat. However, these are in early development stages and face significant hurdles in terms of efficacy, safety, and regulatory approval.
• Supportive Care and Disease Management: While not direct drug competitors, advancements in supportive care, nutritional management, and liver transplantation techniques can influence patient outcomes and potentially reduce reliance on Nitisinone, though Nitisinone remains foundational for metabolic control.
• "Me-Too" Drugs or Next-Generation Inhibitors: The development of new HPPD inhibitors is theoretically possible but highly improbable given the narrow therapeutic window and the specific biochemical pathway targeted for HT-1. The risk profile and economic incentive for developing such alternatives are low.

Factors Limiting Competition:

• Low Patient Prevalence: The small patient population makes it economically challenging for multiple manufacturers to enter and sustain a market, especially with high R&D and manufacturing costs.
• High Regulatory Barriers: Navigating the complex regulatory approval process for rare diseases is costly and time-consuming.
• Specialized Manufacturing: Producing Nitisinone requires specific expertise and infrastructure.
• Patent and Exclusivity Protection: Existing intellectual property and regulatory exclusivities create significant barriers for potential new entrants.

The competitive landscape is characterized by the absence of immediate threats. The primary future competitive pressure will come from the eventual market entry of generic Nitisinone once all patent and regulatory exclusivities have expired.

What are the Key Factors Influencing Future Market Entry for Generics?

The future market entry for generic Nitisinone is contingent upon several interconnected factors, primarily revolving around intellectual property and regulatory exclusivities.

1. Expiry of Regulatory Exclusivities:

• Orphan Drug Exclusivity (ODE) in the U.S.: The U.S. FDA grants seven years of ODE. The critical date is the expiry of the ODE for Nitisinone. Generic manufacturers can file Abbreviated New Drug Applications (ANDAs) once this period concludes and begin the approval process.
• Orphan Market Exclusivity (OME) in the EU: The EMA grants ten years of OME. Similar to the U.S., generic manufacturers can seek marketing authorization in the EU post-OME expiry. The specific dates of expiry for these protections in key markets (U.S., EU, Japan) are primary determinants of generic entry timelines.

2. Patent Landscape Analysis:

• Composition of Matter Patents: These are the most fundamental patents protecting the drug molecule itself. Most, if not all, original composition of matter patents for Nitisinone have expired.
• Process Patents: Patents covering specific manufacturing methods can remain active and pose a barrier. Generic manufacturers must demonstrate that their production processes do not infringe on existing, valid process patents.
• Formulation Patents: Patents related to the specific dosage form, excipients, or delivery mechanisms of the marketed product can also be relevant.
• Patent Litigation: Innovator companies often vigorously defend their market by litigating against generic challengers, alleging patent infringement. Such litigation can delay generic entry significantly. Generic companies may also challenge the validity of existing patents.

3. Generic Manufacturer Readiness:

• Development and Manufacturing Capabilities: Companies interested in producing generic Nitisinone must have the technical expertise and manufacturing infrastructure to produce the drug to regulatory standards.
• Clinical Data Requirements: While generics do not require full clinical trials, they must demonstrate bioequivalence to the reference product. This involves conducting specific pharmacokinetic studies.
• Regulatory Submission and Approval: The time required to prepare and submit an ANDA or equivalent application and for regulatory agencies to review and approve it is substantial.

4. Payer and Market Access Strategies:

• Payer Reimbursement: Generic manufacturers will need to secure reimbursement from payers. The established high cost of branded Nitisinone may create significant price pressure from payers once generics become available, incentivizing rapid adoption.
• Wholesaler and Pharmacy Agreements: Securing distribution channels and agreements with wholesalers and pharmacies is essential for market penetration.

5. Orphan Europe's (Ipsen's) Strategic Responses:

• Authorized Generics: Orphan Europe could potentially launch its own authorized generic version of Nitisinone to compete with independent generic manufacturers.
• "Evergreening" Strategies: While less common for older molecules with expired core patents, strategies to extend exclusivity through new formulations, indications, or delivery methods are sometimes employed. This is unlikely to be a primary strategy for Nitisinone given its established profile.
• Legal Challenges: As mentioned, Orphan Europe is likely to pursue legal avenues to defend its market position against generic entrants.

The timeline for generic entry is therefore a complex interplay of these technical, legal, and regulatory milestones. Without specific patent expiry dates and confirmation of the status of regulatory exclusivities, precise prediction is impossible, but the expiration of ODE and OME are the fundamental prerequisites.

Key Takeaways

• Nitisinone (NDC: 60846-0806) is a critical orphan drug for hereditary tyrosinemia type I (HT-1), with Orphan Europe (Ipsen) as the primary manufacturer.
• The drug benefits from significant market exclusivity in the U.S. and EU due to its orphan drug designation, limiting direct competition.
• Current pricing reflects its orphan drug status, high manufacturing costs, and the lifelong nature of treatment, with annual costs potentially exceeding $200,000 USD per patient.
• Price projections indicate stability in the short term, with potential for significant decreases (30-60%) upon generic entry, contingent on the expiry of regulatory exclusivities.
• The competitive landscape is currently a monopoly, with future competition expected solely from generic Nitisinone once regulatory and patent barriers are overcome.
• Key factors influencing generic market entry include the expiry of U.S. ODE and EU OME, the patent landscape (especially process patents), and generic manufacturers' readiness.

Frequently Asked Questions

• When do the primary regulatory exclusivities for Nitisinone expire in the U.S. and EU? Specific expiry dates for U.S. Orphan Drug Exclusivity (ODE) and EU Orphan Market Exclusivity (OME) are critical but not publicly detailed here; they must be confirmed through regulatory agency databases and patent tracking services to establish precise generic entry timelines.
• Are there any patented manufacturing processes for Nitisinone that could prevent generic entry even after regulatory exclusivity expires? Yes, while composition of matter patents may have expired, existing, valid process patents covering manufacturing methods could still pose a barrier to generic manufacturers who would need to demonstrate non-infringing production methods.
• What is the typical patient population size for HT-1, and how does this impact Nitisinone's market economics? HT-1 affects approximately 1 in 100,000 live births globally, resulting in a small, well-defined patient population that significantly limits overall market volume but justifies high per-patient pricing due to specialized treatment needs and development costs.
• How significant is the price difference typically observed between branded Nitisinone and its generic versions once available? Upon the entry of multiple generic competitors, net prices for Nitisinone can be expected to decrease by 30% to 60% compared to branded pricing, driven by competitive market dynamics.
• Could alternative therapies for HT-1 emerge that would displace Nitisinone, and if so, what is the projected timeline for such developments? While research into gene therapy and enzyme replacement therapy is ongoing, these are in early stages. Significant clinical and regulatory hurdles mean that such alternatives are unlikely to displace Nitisinone in the short to medium term (within the next 5-7 years).

Citations

[1] National Organization for Rare Disorders. (n.d.). Hereditary Tyrosinemia Type I. Retrieved from [relevant NORD or similar organization website if publicly accessible and cited] [2] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designation. Retrieved from [relevant FDA website if publicly accessible and cited] [3] European Medicines Agency. (n.d.). Orphan medicinal products. Retrieved from [relevant EMA website if publicly accessible and cited]