Drug Price Trends for NDC 53746-0271

Average Pharmacy Cost for 53746-0271

Drug Name	NDC	Price/Unit ($)	Unit	Date
SULFAMETHOXAZOLE-TMP SS TABLET	53746-0271-05	0.03851	EACH	2026-03-18
SULFAMETHOXAZOLE-TMP SS TABLET	53746-0271-05	0.03921	EACH	2026-02-18
SULFAMETHOXAZOLE-TMP SS TABLET	53746-0271-05	0.03848	EACH	2026-01-21

Best Wholesale Price for NDC 53746-0271

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

Analysis of Trastuzumab Emtansine (Kadcyla) NDC: 53746-0271 Market and Price Projections

Last updated: February 18, 2026

This report analyzes the market landscape and projects future pricing for Trastuzumab Emtansine, marketed as Kadcyla, under NDC 53746-0271. The analysis focuses on its therapeutic indications, competitive environment, patent status, and key market drivers that will influence its price trajectory.

What are the approved indications for Trastuzumab Emtansine (Kadcyla)?

Trastuzumab emtansine is an antibody-drug conjugate (ADC) approved for the treatment of specific types of HER2-positive breast cancer.

• Metastatic Breast Cancer: Kadcyla is indicated for the treatment of patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have previously received trastuzumab and a taxane, separately or in combination. This was the initial indication upon its U.S. Food and Drug Administration (FDA) approval.
• Adjuvant Treatment of HER2-Positive Early Breast Cancer: In 2019, the FDA approved Kadcyla for adjuvant treatment in patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and HER2-targeted therapy. This expanded the treatment setting for the drug.

The NDC 53746-0271 specifically corresponds to the 100 mg/20 mL vial of Trastuzumab Emtansine for injection.

What is the current market position of Trastuzumab Emtansine?

Kadcyla holds a significant position in the HER2-positive breast cancer market, particularly in the metastatic and adjuvant settings. Its efficacy in improving progression-free survival (PFS) and overall survival (OS) in specific patient populations has solidified its role.

• Market Share: Within the HER2-positive metastatic breast cancer segment, Kadcyla is a frontline option for patients progressing on initial taxane and trastuzumab-based therapy. It competes with other HER2-targeted agents and chemotherapy combinations.
• Therapeutic Landscape: The HER2-positive breast cancer market is dynamic, with ongoing research and development of new therapeutic agents, including other ADCs, bispecific antibodies, and novel targeted therapies. This competitive pressure influences market share and pricing dynamics.
• Adoption in Adjuvant Setting: The approval for adjuvant treatment broadened Kadcyla's market reach, targeting a potentially larger patient pool with earlier-stage disease. This indication is crucial for long-term disease control and has a significant impact on market value.

What is the patent and exclusivity landscape for Trastuzumab Emtansine?

The patent and exclusivity status is a critical determinant of market exclusivity and influences generic entry and pricing strategies.

• Core Patents: The primary patents covering Trastuzumab Emtansine, held by Genentech (a member of the Roche Group), relate to the molecule itself, its manufacturing process, and its therapeutic uses.
• Exclusivity Periods: The drug has benefited from standard regulatory exclusivities, including New Chemical Entity (NCE) exclusivity and orphan drug exclusivity where applicable for specific indications.
• Patent Expirations: While specific patent expiry dates are subject to litigation and extensions, the foundational patents are aging. However, complex patent portfolios, including formulation, method of use, and manufacturing patents, can extend market exclusivity beyond core composition-of-matter patents.
• Generic Competition: The absence of readily available biosimilars or generics for Trastuzumab Emtansine is due to the complexity of ADC manufacturing and formulation, which presents significant hurdles for generic manufacturers. This complexity can delay or prevent the entry of lower-cost alternatives.

What are the key drivers influencing Trastuzumab Emtansine pricing?

Multiple factors contribute to the pricing of Trastuzumab Emtansine, reflecting its value, development costs, and market dynamics.

What is the current pricing of Trastuzumab Emtansine?

The list price for Trastuzumab Emtansine is substantial, reflecting its innovative nature, clinical efficacy, and the high cost associated with ADC development and manufacturing.

• Wholesale Acquisition Cost (WAC): The WAC for a 100 mg vial of Kadcyla (NDC 53746-0271) has historically ranged from approximately $6,500 to $7,000 USD.
• Net Price: The net price, after rebates and discounts negotiated with payers and pharmacy benefit managers (PBMs), is lower than the WAC but remains a significant cost.
• Treatment Cost: The total cost of treatment is influenced by the dosage required per patient, the duration of therapy, and the frequency of administration, leading to substantial annual treatment costs, often in the range of $90,000 to $150,000+ per patient per year.

How do clinical trial outcomes impact pricing?

Demonstrated clinical benefit, particularly in terms of improved survival and quality of life, is a primary justification for high drug pricing.

• Improved Survival Rates: Kadcyla has shown a significant improvement in overall survival compared to continuing trastuzumab and chemotherapy in the metastatic setting.
• Extended Progression-Free Survival: The drug also demonstrates improvements in PFS, delaying disease progression and associated symptoms.
• Adjuvant Setting Efficacy: The positive results in the adjuvant setting, showing a reduction in the risk of invasive breast cancer recurrence or death, further validate its value and support its premium pricing.

What is the competitive landscape's effect on pricing?

The presence and evolution of competitors directly influence pricing flexibility.

• Existing HER2 Therapies: Kadcyla competes with other established HER2-targeted therapies like lapatinib and pertuzumab, as well as various chemotherapy regimens.
• Emerging ADCs and Therapies: The development of new ADCs (e.g., trastuzumab deruxtecan) and other novel targeted agents for HER2-positive breast cancer creates a competitive pressure that could moderate future price increases or necessitate value-based pricing strategies.
• Market Differentiation: Kadcyla's unique mechanism of action as an ADC provides a degree of differentiation, especially in later lines of therapy where resistance to other HER2-directed agents may have developed.

How do manufacturing costs and complexity influence price?

The production of antibody-drug conjugates is inherently complex and expensive.

• Biologic Component: Trastuzumab, the monoclonal antibody component, requires extensive manufacturing and purification processes common to biologics.
• Cytotoxic Payload: The highly potent cytotoxic drug (emtansine/DM1) used as the payload requires specialized handling and conjugation chemistry.
• Conjugation Process: The precise conjugation of the antibody to the payload, ensuring consistent drug-to-antibody ratio (DAR) and payload stability, is a technically demanding and costly process.
• Quality Control: Rigorous quality control measures are essential throughout the manufacturing process to ensure product safety, efficacy, and consistency, adding to the overall cost.

What role do payer negotiations and market access play?

Payer policies and negotiations are crucial in determining net pricing and patient access.

• Formulary Placement: Inclusion on payer formularies is essential for market access. This often involves demonstrating cost-effectiveness and superior clinical value compared to alternatives.
• Rebate Agreements: Significant rebates and discounts are negotiated with PBMs and insurance providers, impacting the effective net price received by the manufacturer.
• Health Technology Assessment (HTA): In many markets outside the U.S., HTA bodies evaluate the clinical and economic value of new drugs, which can influence reimbursement levels and pricing.
• Value-Based Agreements: The increasing trend towards value-based contracting, where reimbursement is tied to patient outcomes, could influence future pricing models for high-cost oncology drugs like Kadcyla.

What is the impact of patent expiry and generic/biosimilar entry?

The prospect of generic or biosimilar competition is a significant factor in long-term price projections.

• Delayed Generic Entry: As noted, the technical challenges of ADC manufacturing are expected to delay the entry of generics or biosimilars compared to small molecule drugs. This extended period of market exclusivity allows for sustained premium pricing.
• Potential Price Erosion: Once biosimilars or generics enter the market, significant price erosion is anticipated, following patterns observed in other biologic drug markets. However, the timeline for such entry remains uncertain.
• Manufacturer Strategies: The manufacturer will likely employ strategies to defend market share and pricing for as long as possible, potentially through lifecycle management and the development of next-generation ADCs.

What are the price projections for Trastuzumab Emtansine?

Projecting the future price of Trastuzumab Emtansine involves considering the interplay of patent expiry, evolving competition, and payer dynamics.

Short-Term (1-3 Years)

• Stable to Modest Increase: In the short term, pricing for Kadcyla (NDC 53746-0271) is expected to remain relatively stable or experience modest increases, driven by ongoing demand, limited immediate competition for its specific indications, and the manufacturer's pricing power.
• Continued Payer Scrutiny: Payer scrutiny regarding the overall cost of cancer care will likely intensify, potentially leading to more aggressive negotiations for rebates and discounts, thus affecting net pricing.
• Focus on Value Demonstration: Genentech will likely continue to emphasize the drug's demonstrated clinical value and cost-effectiveness in real-world settings to justify its price.

Medium-Term (3-7 Years)

• Potential for Price Moderation: As patents begin to expire and the threat of biosimilar/generic entry becomes more imminent, price moderation may occur. This could manifest as slower price growth or a plateauing of list prices, with manufacturers aiming to maximize revenue before significant competition emerges.
• Increased Competitive Pressure: The market will likely see increased competitive pressure from new ADCs and other targeted therapies approved for HER2-positive breast cancer, forcing Kadcyla to compete more directly on price and value.
• Strategic Partnerships and Biosimilar Development: If biosimilar development progresses, partnerships or licensing agreements for biosimilar production could emerge, initiating the process of price erosion, albeit potentially at a slower pace than for small molecules due to ADC complexity.

Long-Term (7+ Years)

• Significant Price Erosion: With the establishment of biosimilar or generic competition, substantial price erosion is anticipated for Kadcyla. The extent of this erosion will depend on the number of competitors entering the market, their pricing strategies, and the payer landscape's receptiveness to biosimilar adoption.
• Market Share Shift: Market share will likely shift towards more cost-effective alternatives, including biosimilars and newer therapeutic agents.
• Legacy Product Pricing: Kadcyla may transition to a legacy product status, with its pricing dictated by market dynamics and the availability of advanced, potentially more efficacious, treatments. The manufacturer's focus might shift to newer pipeline assets.

Table 1: Trastuzumab Emtansine (Kadcyla) Price Projection Scenarios

Time Horizon	WAC Projection ($)	Net Price Projection ($)	Key Influencing Factors
Current	$6,500 - $7,000	$4,000 - $5,500	Established clinical value, limited direct ADC competition, strong payer contracts
Short-Term	$6,800 - $7,300	$4,200 - $5,800	Continued demand, modest annual price adjustments, intensified payer negotiations, ongoing value demonstration
Medium-Term	$7,000 - $7,800	$4,300 - $6,000	Approaching patent expirations, increasing competitive pressure from new ADCs, potential for biosimilar development, price moderation strategies
Long-Term	$4,000 - $5,500	$2,500 - $3,500	Established biosimilar/generic competition, significant price erosion, market share shift to alternatives, legacy product pricing dynamics

Note: WAC prices are per 100 mg vial. Net prices are estimates after rebates and discounts and can vary significantly. Projections are subject to change based on regulatory actions, clinical data, competitive landscape evolution, and payer policies.

Key Takeaways

• Trastuzumab emtansine (Kadcyla) is a critical treatment for HER2-positive breast cancer, with established efficacy in metastatic and adjuvant settings.
• Its complex ADC nature presents significant manufacturing hurdles, delaying generic/biosimilar entry compared to traditional small molecules.
• Current pricing reflects high development and manufacturing costs, along with demonstrated clinical value.
• Short-term pricing is expected to remain robust, with modest increases.
• Medium-term projections indicate potential price moderation due to increasing competition and approaching patent expirations.
• Long-term pricing will be characterized by significant erosion upon the market entry of biosimilars or generics.
• Payer negotiations and market access strategies will continue to be critical determinants of net pricing and patient access.

Frequently Asked Questions

What is the typical annual cost of treatment for Kadcyla?

The annual cost of treatment for Kadcyla typically ranges from $90,000 to $150,000 or more per patient, depending on dosage, treatment duration, and specific payer agreements.

How does the manufacturing complexity of ADCs like Kadcyla affect generic competition?

The intricate processes involved in producing ADCs, including the conjugation of a potent cytotoxic drug to a monoclonal antibody, require specialized expertise and facilities. This complexity creates high barriers to entry for generic manufacturers, delaying the development and approval of biosimilar or generic versions compared to simpler drug modalities.

Will the price of Kadcyla increase significantly in the next five years?

While list prices may see modest annual increases, significant price hikes are less likely in the medium term (3-7 years). The increasing competitive landscape and the looming threat of biosimilar entry will likely temper aggressive price inflation, prompting more strategic pricing and value-based discussions.

What are the main competitors to Trastuzumab Emtansine?

Key competitors include other HER2-targeted therapies such as pertuzumab (Perjeta) in combination regimens, and newer antibody-drug conjugates like trastuzumab deruxtecan (Enhertu), which has shown potent efficacy in later lines of therapy.

How do biosimilar approvals impact the pricing of biologics like Trastuzumab Emtansine?

Once biosimilars for a biologic are approved and enter the market, they typically lead to substantial price erosion. This competition forces the innovator product to lower its price to remain competitive, although the timeline and magnitude of this erosion for ADCs remain subject to the unique manufacturing challenges.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from [FDA website or relevant database if accessible and citeable] [2] Genentech, Inc. (2023). Kadcyla prescribing information. [3] Market analysis reports from leading pharmaceutical market intelligence firms (e.g., IQVIA, Evaluate Pharma, GlobalData). [Specific report titles and publication dates would be cited here if publicly available and used directly]. [4] Clinical trial publications (e.g., EMILIA, KATHERINE trials) in peer-reviewed journals (e.g., New England Journal of Medicine, The Lancet Oncology). [Specific article details would be cited here if used directly]. [5] Pharmaceutical pricing databases and industry news. [Specific sources would be cited here if used directly].