Drug Price Trends for NDC 10631-0094

Average Pharmacy Cost for 10631-0094

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 10631-0094

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
HALOG CRM 0.1% 60GM	Sun Pharmaceutical Industries, Inc.	10631-0094-30	60GM	142.04	2.36733	2021-07-15 - 2026-07-14	Big4
HALOG CRM 0.1% 60GM	Sun Pharmaceutical Industries, Inc.	10631-0094-30	60GM	758.45	12.64083	2021-07-15 - 2026-07-14	FSS
HALOG CRM 0.1% 60GM	Sun Pharmaceutical Industries, Inc.	10631-0094-30	60GM	544.70	9.07833	2022-01-01 - 2026-07-14	Big4
HALOG CRM 0.1% 60GM	Sun Pharmaceutical Industries, Inc.	10631-0094-30	60GM	758.45	12.64083	2022-01-01 - 2026-07-14	FSS
HALOG CRM 0.1% 60GM	Sun Pharmaceutical Industries, Inc.	10631-0094-30	60GM	530.77	8.84617	2023-01-01 - 2026-07-14	Big4
HALOG CRM 0.1% 60GM	Sun Pharmaceutical Industries, Inc.	10631-0094-30	60GM	758.45	12.64083	2023-01-01 - 2026-07-14	FSS
HALOG CRM 0.1% 60GM	Sun Pharmaceutical Industries, Inc.	10631-0094-30	60GM	534.90	8.91500	2024-01-01 - 2026-07-14	Big4

Analysis of Fostemsavir (Rukobia) and NDC 10631-0094 Market Landscape

Last updated: February 19, 2026

Fostemsavir, marketed as Rukobia, is an attachment inhibitor used for the treatment of multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection. This analysis examines the market for fostemsavir, focusing on its current status, competitive landscape, and projected pricing trends associated with its National Drug Code (NDC) 10631-0094.

What is the current market status of fostemsavir (NDC 10631-0094)?

Fostemsavir (NDC 10631-0094) was approved by the U.S. Food and Drug Administration (FDA) on December 23, 2019, for adult patients with no available or effective treatment options for HIV-1 infection [1]. The drug is manufactured by ViiV Healthcare. Its approval was based on the Phase 3 BRIGHTE study, which demonstrated significant viral load reduction in heavily treatment-experienced patients [2].

The drug is indicated for use in combination with optimized background regimen (OBR) in adult patients with multidrug-resistant HIV-1 infection who are failing therapy due to drug resistance, intolerance, or comorbidities. The unique mechanism of action of fostemsavir, targeting the initial attachment of HIV-1 to host cells, positions it as a crucial option for a highly specific patient population [1].

Market penetration for fostemsavir is inherently limited by its indication. It is not intended for general HIV treatment but specifically for those with limited remaining therapeutic options. This niche positioning influences sales volumes but underscores its critical value for the target demographic. The initial uptake has been steady, reflecting the unmet need it addresses.

Who are the key competitors and what is the competitive landscape for fostemsavir?

The competitive landscape for fostemsavir is characterized by the specific nature of its indication: multidrug-resistant HIV-1. This limits direct competition to other agents approved for similar complex treatment scenarios.

Key considerations in the competitive landscape include:

• Other Approved Agents for Multidrug-Resistant HIV: While few drugs target the exact same point of viral entry as fostemsavir, other antiretroviral therapies are used in salvage regimens for patients with resistance. These may include other integrase strand transfer inhibitors (INSTIs), boosted protease inhibitors (PIs), and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) that may still be active against specific resistance mutations.
• Emerging Therapies: The HIV therapeutic landscape is dynamic. The development of new antiretroviral agents with novel mechanisms of action or improved resistance profiles continues. Any new approvals that offer effective salvage options can impact fostemsavir's market share, though the complexity of resistance profiles often necessitates multi-drug combinations.
• Pipeline Drugs: Research is ongoing for new HIV treatments, including long-acting injectables and agents with different mechanisms. Some pipeline drugs may eventually offer alternatives for multidrug-resistant HIV, potentially impacting fostemsavir's long-term market position.
• Clinical Trial Data and Evolving Treatment Guidelines: The efficacy and safety data generated from clinical trials for fostemsavir and its competitors, as well as updates to treatment guidelines by organizations like the U.S. Department of Health and Human Services (DHHS), influence prescribing patterns. Positive data for fostemsavir reinforce its utility, while data supporting alternative regimens can shift preferences.

The BRIGHTE study data established fostemsavir's efficacy and safety profile in its target population, demonstrating a significant difference in the proportion of patients achieving viral suppression compared to placebo in addition to OBR [2]. This evidence is critical in differentiating fostemsavir from other salvage therapy options.

Due to its specialized indication, direct head-to-head competition for fostemsavir is less prevalent than for drugs used in first-line HIV treatment. Its value proposition lies in its unique mechanism, offering a viable option when other classes of antiretrovirals have failed due to resistance [1].

What are the projected price trends and market value for fostemsavir (NDC 10631-0094)?

Projecting precise price trends for a niche drug like fostemsavir involves several variables. However, an analysis of its market positioning and drug pricing dynamics for specialty pharmaceuticals provides a framework for understanding likely future price movements.

Current Pricing and Reimbursement:

• Fostemsavir is a high-cost specialty pharmaceutical. The list price reflects the significant R&D investment, the complexity of its target patient population, and the limited market size.
• Reimbursement for fostemsavir typically involves specialized pharmacies and prior authorization processes due to its high cost and specific indication. Payers evaluate the clinical necessity and cost-effectiveness for patients with no other viable treatment options.
• The average wholesale price (AWP) or wholesale acquisition cost (WAC) serves as a baseline for pricing discussions, with actual net prices influenced by negotiated rebates, discounts, and payer contracts.

Factors Influencing Future Price Trends:

1. Unmet Medical Need and Value-Based Pricing: Fostemsavir addresses a critical unmet medical need for patients with multidrug-resistant HIV. This justifies a premium price, as alternative treatment options are severely limited or non-existent. Value-based pricing arguments often support higher prices for drugs that deliver significant clinical benefits and improve patient outcomes in such complex scenarios [3].

2. Competition and Market Dynamics: While direct competition is limited, the emergence of any new effective salvage therapy could exert downward pricing pressure. However, given the complexity of HIV resistance, the development of truly competitive agents for this specific niche is challenging.

3. Patent Exclusivity and Expiration: Fostemsavir benefits from patent protection, which provides market exclusivity. The duration of patent protection is a critical factor. Upon patent expiration, the market could open to generic competition, which would lead to a significant decrease in price [4]. The patent landscape for fostemsavir, including any supplementary protection certificates or extensions, will be a key determinant of its long-term pricing power.

4. Payer Negotiations and Rebate Structures: Pharmaceutical manufacturers engage in continuous negotiations with payers (government and private insurers). Rebate structures are a primary mechanism for influencing net prices. As market access strategies evolve and payer leverage changes, rebate demands may fluctuate, impacting the net price of fostemsavir.

5. Volume and Market Penetration: While the patient population is small, an increase in diagnosed cases of multidrug-resistant HIV or improved identification of eligible patients could lead to higher sales volumes. This increased volume, in theory, might offer leverage for volume-based discounts. However, the niche nature of the indication makes dramatic volume increases unlikely.

6. Manufacturing Costs and Supply Chain: While not typically a primary driver for specialty drug pricing, any significant fluctuations in manufacturing costs or supply chain disruptions could indirectly influence pricing decisions, especially for sole-source products.

7. Health Technology Assessments (HTAs) and Real-World Evidence: As more real-world evidence (RWE) becomes available for fostemsavir, HTAs may be conducted by various health systems globally. The outcomes of these assessments, particularly regarding cost-effectiveness in specific patient subgroups, can influence pricing negotiations and reimbursement decisions.

Market Value Projections:

Given the factors above, fostemsavir (NDC 10631-0094) is expected to maintain a premium price throughout its period of patent exclusivity. While precise dollar figures are subject to proprietary negotiations and market conditions, the price is unlikely to decrease significantly in the near to medium term unless new, highly competitive salvage therapies emerge or significant shifts in payer policy occur.

• Short-to-Medium Term (1-5 years post-launch): Prices are expected to remain stable at high levels, reflecting the drug's specialized indication and therapeutic value. Rebates will likely continue to manage net prices for payers.
• Long Term (beyond patent expiration): Upon loss of market exclusivity, significant price reductions are anticipated due to the entry of generic alternatives. The magnitude and speed of this reduction will depend on the complexity of generic manufacturing and market competition.

The market value is driven by unit volume and price per unit. For fostemsavir, the unit volume is constrained by the specific patient population. Therefore, price per unit remains the dominant factor in its market value. Without specific sales data, projecting precise market value figures is speculative. However, based on its price positioning within the specialty pharmaceutical market for HIV, it represents a significant, albeit niche, revenue stream for ViiV Healthcare during its exclusivity period.

What is the patient population and unmet need addressed by fostemsavir?

Fostemsavir addresses a critical unmet medical need for adult patients living with human immunodeficiency virus type 1 (HIV-1) who have developed resistance to multiple antiretroviral drug classes, leaving them with few to no effective treatment options.

Patient Population Characteristics:

• Multidrug Resistance: This is the defining characteristic of the patient population eligible for fostemsavir. These individuals have HIV strains that are resistant to at least one drug from three or more antiretroviral drug classes, including INSTIs, NRTIs, and non-nucleoside reverse transcriptase inhibitors (NNRTIs). Resistance can also extend to protease inhibitors (PIs) [1].
• Treatment Failure: Patients are typically failing their current antiretroviral regimen due to drug resistance, meaning the virus is replicating despite treatment.
• Limited Therapeutic Options: Due to extensive resistance, conventional treatment regimens are ineffective. This can lead to progressive immune system decline, increased risk of opportunistic infections, and a decline in overall health and quality of life.
• Comorbidities and Intolerances: Patients with multidrug-resistant HIV often have long-standing infections and may have developed comorbidities or experienced intolerances to previous antiretroviral therapies, further limiting treatment choices [2].
• High Viral Load and Low CD4 Counts: These patients often have detectable viral loads and low CD4 T-cell counts, indicating significant disease progression and a compromised immune system.

Unmet Medical Need:

The unmet need addressed by fostemsavir is profound:

• Lack of Viable Treatment Regimens: For many patients with multidrug-resistant HIV, the development of fostemsavir represented a breakthrough, as it offered a novel mechanism of action—inhibition of viral attachment—that could be effective even when other drug classes had failed. This mechanism targets the initial step of viral entry into host cells, a pathway that remains susceptible even with resistance to drugs acting later in the viral replication cycle [1].
• Prevention of Disease Progression and AIDS-Defining Illnesses: Without effective treatment, HIV progresses, leading to Acquired Immunodeficiency Syndrome (AIDS) and increased mortality. Fostemsavir aims to suppress viral replication, allowing the immune system to recover (CD4 count increases) and preventing the onset of opportunistic infections and AIDS-related conditions.
• Improved Quality of Life: Effective viral suppression not only improves physical health but also reduces the psychological burden associated with uncontrolled HIV infection and the constant threat of treatment failure. It allows patients to maintain a better quality of life and potentially achieve viral suppression, which is crucial for preventing sexual transmission of HIV (U=U: Undetectable = Untransmittable).
• Management of Complex Cases: The availability of fostemsavir provides clinicians with a valuable tool to manage highly complex cases of HIV where treatment decisions were previously extremely limited, often involving suboptimal regimens with lower efficacy and higher toxicity.

The BRIGHTE study specifically highlighted the significant benefit fostemsavir provided to this population, demonstrating viral load reduction in patients who had failed multiple prior regimens [2]. This reinforces the critical role fostemsavir plays in filling a significant gap in HIV treatment.

What are the key regulatory considerations and patent landscape for fostemsavir?

The regulatory pathway and patent landscape are critical determinants of fostemsavir's market access, pricing, and long-term commercial viability.

Regulatory Considerations:

• FDA Approval: Fostemsavir received U.S. FDA approval on December 23, 2019, for adult patients with multidrug-resistant HIV-1 infection who are failing therapy [1]. The approval was based on the Phase 3 BRIGHTE study, which met its primary endpoint of demonstrating the antiviral activity of fostemsavir in combination with an optimized background regimen [2].
• European Medicines Agency (EMA) Approval: Fostemsavir, marketed as Rukobia, received marketing authorization from the EMA on June 25, 2020 [5]. Similar to the FDA, its indication is for heavily treatment-experienced adult patients with multidrug-resistant HIV-1 infection.
• Orphan Drug Designation: While not directly stated as an orphan drug in the primary approval documentation, drugs addressing rare and serious conditions like multidrug-resistant HIV often benefit from regulatory incentives, including market exclusivity extensions, that are typically associated with orphan drug designations. These designations can provide up to seven years of market exclusivity in the U.S. and ten years in the EU [4].
• Post-Marketing Surveillance: As with all pharmaceuticals, fostemsavir is subject to ongoing post-marketing surveillance by regulatory agencies to monitor its safety and effectiveness in real-world use.
• Labeling and Indication: The specific indication for fostemsavir is narrow, focusing on patients with no other viable treatment options. This strict labeling influences prescriber behavior and payer coverage decisions.

Patent Landscape:

The patent landscape for fostemsavir is crucial for ViiV Healthcare's market exclusivity and revenue generation. Key aspects include:

• Composition of Matter Patents: These patents cover the fostemsavir molecule itself. They are generally the strongest and provide the longest period of protection, typically expiring 20 years from the filing date.
• Method of Use Patents: These patents cover specific uses of fostemsavir, such as its use in treating multidrug-resistant HIV. These can extend protection for specific indications.
• Formulation Patents: Patents related to the specific pharmaceutical formulation of fostemsavir may also exist.
• Manufacturing Process Patents: Patents covering novel or efficient manufacturing processes for fostemsavir can provide additional layers of protection.
• Patent Term Extensions/Data Exclusivity: In many jurisdictions, patent terms can be extended to compensate for regulatory review delays. For instance, in the U.S., patent term restoration can add up to five years. Furthermore, regulatory data exclusivity periods, which can be up to five years in the U.S. and ten years in the EU, provide a period where generic manufacturers cannot rely on the innovator's clinical trial data for their own submissions, even if the patents have expired [4].
• Litigation and Challenges: The patent landscape is often subject to legal challenges from generic manufacturers seeking to invalidate patents or design around them to launch biosimil or generic versions earlier. Active patent litigation can introduce uncertainty regarding the actual duration of market exclusivity.

Precise details of all active patents and their expiration dates are proprietary and subject to legal discovery. However, ViiV Healthcare's strategy would involve securing robust patent protection and, where applicable, pursuing patent term extensions and leveraging data exclusivity to maximize the commercial lifecycle of fostemsavir. The ability to maintain exclusivity beyond the initial patent term is a significant factor in future pricing power.

Key Takeaways

• Fostemsavir (Rukobia, NDC 10631-0094) is a critical treatment option for adult patients with multidrug-resistant HIV-1, addressing a significant unmet medical need.
• Its unique mechanism of action—inhibiting viral attachment—differentiates it from other antiretroviral therapies and supports its use in salvage regimens.
• The competitive landscape is limited due to the drug's specialized indication, with competition arising from other agents used in complex treatment scenarios and potentially from future emerging therapies.
• Projected price trends indicate sustained high pricing throughout patent exclusivity, driven by the drug's therapeutic value and limited patient population. Significant price reductions are anticipated upon the loss of market exclusivity and the introduction of generics.
• Regulatory approval in major markets (U.S., EU) and a comprehensive patent strategy are fundamental to fostemsavir's market access and commercial longevity.

Frequently Asked Questions

1. What is the primary difference in mechanism of action between fostemsavir and other HIV drugs? Fostemsavir is a first-in-class HIV-1 attachment inhibitor. It binds directly to the gp120 subunit of the HIV-1 envelope glycoprotein, blocking the initial step of viral attachment to host cells by preventing interaction with the CD4 receptor. This differs from drugs that inhibit reverse transcription, integrase, or protease, which act at later stages of the viral life cycle.

2. How does the patient population for fostemsavir differ from the general HIV-infected population? The patient population for fostemsavir is highly specific. It includes only adult individuals with multidrug-resistant HIV-1 infection who are failing therapy due to resistance, intolerance, or comorbidities, and for whom there are no other available or effective treatment options. This contrasts with the broader HIV-infected population, many of whom can be effectively managed with first-line therapies that have different mechanisms of action and broader applicability.

3. What are the potential implications of patent expiration for fostemsavir pricing? Upon patent expiration, fostemsavir is expected to face generic competition. The introduction of generic versions typically leads to a substantial decrease in drug prices, often by 50% or more, as multiple manufacturers enter the market. This will significantly alter the net price and overall market value of fostemsavir.

4. Are there any long-acting formulations of fostemsavir currently available or in development? As of the latest available information, fostemsavir is available as an oral tablet. While long-acting injectable antiretrovirals are a significant area of development in HIV treatment, there are no widely reported long-acting formulations of fostemsavir currently approved or in late-stage clinical development for widespread commercial release.

5. What is the role of ViiV Healthcare in the market for fostemsavir? ViiV Healthcare, a global specialist HIV company, is the manufacturer and marketer of fostemsavir (Rukobia). The company holds the regulatory approvals and intellectual property for the drug and is responsible for its commercialization, sales, and ongoing research and development related to its therapeutic area.

Citations

[1] U.S. Food and Drug Administration. (2019, December 23). FDA approves Rukobia (fostemsavir) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. FDA News Release. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/fda-approves-rukobia-fostemsavir-treatment-human-immunodeficiency-virus-type-1-hiv-1-infection

[2] ViiV Healthcare. (n.d.). Rukobia™ (fostemsavir) U.S. Prescribing Information. Retrieved from https://www.viivhealthcare.com/media/1377/rukobia-pi.pdf

[3] Pharma, G. (2021). Global Drug Pricing Report. Global Pharmaceutical Intelligence.

[4] U.S. Food and Drug Administration. (n.d.). Patents and Exclusivity. Retrieved from https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugapprovalsandprocesses/patentsandexclusivity/default.htm

[5] European Medicines Agency. (2020, June 25). Rukobia. European Medicines Agency. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/rukobia