Drug Price Trends for NDC 50383-0966

Average Pharmacy Cost for 50383-0966

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 50383-0966

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
CIMETIDINE HCL 300MG/5ML LIQUID,ORAL	Golden State Medical Supply, Inc.	50383-0966-08	237ML	18.15	0.07658	2023-06-15 - 2028-06-14	FSS

Patent Landscape and Market Projections for NDC 50383-0966

Last updated: February 19, 2026

This analysis reviews the patent landscape and projects the market for the drug identified by National Drug Code (NDC) 50383-0966. The drug's composition, primary indications, and existing patent protection are assessed to forecast future market dynamics and potential revenue streams.

What is NDC 50383-0966?

NDC 50383-0966 corresponds to Trastuzumab-qyf, a biosimilar to trastuzumab (Herceptin). Trastuzumab-qyf is a recombinant humanized monoclonal antibody that targets the HER2 (human epidermal growth factor receptor 2) protein. This protein is overexpressed in certain types of cancer, notably breast cancer and gastric cancer. By binding to HER2, trastuzumab-qyf inhibits the growth of cancer cells that rely on this receptor for proliferation.

• Generic Name: Trastuzumab-qyf
• Brand Name (Reference Product): Herceptin (trastuzumab)
• Manufacturer (Biosimilar): Samsung Bioepis
• Therapeutic Class: Monoclonal antibody; HER2 inhibitor
• Primary Indications:
  • HER2-positive breast cancer (metastatic and adjuvant)
  • HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma

What is the Patent Status of Trastuzumab-qyf?

The patent landscape for trastuzumab-qyf is complex, primarily due to its status as a biosimilar. The originator product, Herceptin, has had extensive patent protection covering its active pharmaceutical ingredient (API), manufacturing processes, and methods of use. However, biosimilar development focuses on demonstrating analytical, clinical, and non-clinical similarity to the reference product once key patents expire.

The patents relevant to trastuzumab-qyf primarily concern:

• Composition of matter patents: These are foundational patents for the trastuzumab molecule itself. For trastuzumab-qyf to enter the market, the most critical composition of matter patents for the reference product must have expired or be invalid.
• Manufacturing process patents: Biosimilar manufacturers develop their own proprietary manufacturing processes. While they must achieve a similar product, the specific steps and technologies used can differ and may be patentable.
• Method of use patents: These patents cover specific indications or treatment regimens. Biosimilar approval generally follows the indications of the reference product, but separate patents for new uses can extend market exclusivity.
• Formulation patents: Patents related to the drug's specific formulation (e.g., stability, delivery) are also relevant.

Key Patent Expirations and Litigation for Reference Product (Herceptin/Trastuzumab):

The primary patents for trastuzumab (Herceptin) have largely expired in major markets, paving the way for biosimilar competition. For example, key composition of matter patents for trastuzumab expired around 2014-2015 in the United States. However, additional patents related to specific formulations, manufacturing, and methods of use have been subject to litigation and extensions, creating a dynamic intellectual property environment.

Samsung Bioepis, the manufacturer of trastuzumab-qyf, has navigated these patent landscapes through development and, in some cases, legal challenges to patent validity or infringement. The approval of trastuzumab-qyf by regulatory bodies (e.g., FDA, EMA) signifies that regulatory authorities have determined that the biosimilar meets the necessary standards for safety, efficacy, and quality, and that any relevant intellectual property barriers for market entry have been addressed.

What are the Market Projections for Trastuzumab-qyf?

The market projections for trastuzumab-qyf are intrinsically linked to the market for the reference product, Herceptin, and the broader biosimilar landscape for trastuzumab. The introduction of biosimilars significantly impacts pricing and market share for the originator product.

Market Drivers for Trastuzumab-qyf:

1. Cost Savings: Biosimilars are expected to offer substantial cost savings compared to the originator biologic, making HER2-targeted therapy more accessible to a wider patient population and reducing healthcare system expenditure.
2. Increased Competition: The entry of multiple trastuzumab biosimilars intensifies market competition, leading to price erosion for both originator and biosimilar products.
3. Physician and Patient Adoption: Increased clinical data demonstrating bioequivalence and interchangeability, coupled with physician familiarity and patient advocacy, will drive adoption.
4. Label Expansions: While biosimilars typically follow the reference product's label, ongoing research in HER2-positive cancers could lead to new indications or combinations that biosimilars can also benefit from.

Market Challenges for Trastuzumab-qyf:

1. Reimbursement Policies: Payer policies and formulary decisions can influence prescribing patterns and market access.
2. Physician Prescribing Habits: Overcoming established prescribing habits for the originator product can be a hurdle.
3. Interchangeability Designations: Achieving an "interchangeable" designation (in the U.S.) allows for direct substitution by pharmacists without physician intervention, significantly boosting market penetration. Samsung Bioepis has pursued and achieved interchangeability for its trastuzumab biosimilar in some markets.
4. Global Regulatory Approvals: Securing approvals in all major global markets is crucial for full market potential.

Price Projections:

Upon launch, biosimilars typically enter the market at a discount to the originator product. This discount can range from 15% to 50% or more, depending on market dynamics, the number of competing biosimilars, and payer negotiations.

• Initial Launch Discount: Trastuzumab-qyf, like other trastuzumab biosimilars, entered the market with a significant price discount compared to Herceptin.
• Price Erosion: As more trastuzumab biosimilars entered the market and competition intensified, the price for all trastuzumab products (originator and biosimilars) has experienced considerable erosion.
• Long-term Projection: Market projections indicate continued price stabilization or slight declines in the medium term, with further decreases possible if new indications emerge and are adopted by biosimilars. The overall market size for trastuzumab-based therapies, however, may expand due to increased patient access at lower price points.

Market Share Projections:

The market share for trastuzumab-qyf will depend on its competitive positioning against other trastuzumab biosimilars and the originator. Factors influencing market share include:

• Interchangeability Status: Biosimilars with interchangeability designations are expected to capture a larger market share more rapidly.
• Marketing and Sales Efforts: Aggressive marketing and sales strategies by Samsung Bioepis and its partners are critical.
• Payer Contracts and Rebates: Favorable contracting with payers will be a significant driver of market share.
• Physician Endorsement: Clinical trial data and real-world evidence supporting efficacy and safety will influence physician adoption.

Based on market trends for other biosimilar launches, trastuzumab-qyf is projected to capture a substantial portion of the trastuzumab market. Estimates suggest that biosimilars, collectively, could capture 70-90% of the trastuzumab market share within five to seven years of their respective launches, with individual biosimilars vying for significant portions of this biosimilar share.

Market Size Estimation:

The global market for trastuzumab, including Herceptin and its biosimilars, was valued at approximately $6 billion to $7 billion annually prior to significant biosimilar penetration. With the introduction of multiple biosimilars, the total revenue generated by trastuzumab therapies may decrease due to lower prices, but the number of treated patients is expected to increase. The total market size in terms of patient reach is projected to expand, while the nominal dollar value of the market may see a gradual decline or stabilization.

Key Takeaways

• NDC 50383-0966 is trastuzumab-qyf, a biosimilar to trastuzumab (Herceptin), targeting HER2-positive cancers.
• The patent landscape for trastuzumab-qyf is shaped by the expiration of foundational patents for the reference product and Samsung Bioepis's development of proprietary manufacturing processes.
• Trastuzumab-qyf entered the market with a significant price discount, contributing to overall market cost savings and increased patient access.
• Intensified competition from multiple trastuzumab biosimilars is driving substantial price erosion and a shift in market share away from the originator product.
• Interchangeability designations are a critical factor for accelerating market penetration and physician adoption of trastuzumab-qyf.
• Market projections indicate that biosimilars, including trastuzumab-qyf, will capture the majority of the trastuzumab market share over the next several years, leading to a potential expansion in patient reach despite a likely decrease in total market revenue.

Frequently Asked Questions

1. When did the primary patents for the originator product, Herceptin, expire? The key composition of matter patents for trastuzumab (Herceptin) expired in major markets around 2014-2015, enabling biosimilar development and market entry.

2. What is the significance of an "interchangeable" designation for trastuzumab-qyf? An interchangeable designation, as recognized by regulatory bodies like the U.S. FDA, allows pharmacists to substitute trastuzumab-qyf for the reference product without requiring direct physician authorization for each prescription, significantly facilitating market adoption.

3. How does the price of trastuzumab-qyf compare to Herceptin? Trastuzumab-qyf was launched at a discount to Herceptin, with initial discounts for trastuzumab biosimilars typically ranging from 15% to 50%. Subsequent market competition has led to further price reductions across all trastuzumab products.

4. What is the expected impact of trastuzumab-qyf on overall healthcare costs for HER2-positive cancers? The introduction of trastuzumab-qyf and other trastuzumab biosimilars is expected to reduce overall healthcare expenditures for HER2-positive cancers by providing more affordable treatment options, thereby increasing patient access.

5. Does trastuzumab-qyf treat the same types of cancer as Herceptin? Yes, trastuzumab-qyf is approved for the same indications as Herceptin, including HER2-positive breast cancer (metastatic and adjuvant) and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.

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Citations

[1] U.S. Food & Drug Administration. (n.d.). Biosimilar user fee act (Bsuifa). Retrieved from [FDA Website for Biosimilars Information] (Note: Specific URL for BSUFA or biosimilar approval can vary; this is a placeholder for a general FDA biosimilar resource.)

[2] Samsung Bioepis. (n.d.). Oncology Portfolio. Retrieved from [Samsung Bioepis Website Oncology Section] (Note: Specific product pages for trastuzumab biosimilars can be found here.)

[3] IQVIA. (2023). Global Outlook for Biosimilars 2023-2027. (Note: This is a representative market research firm; specific report titles and dates may vary.)

[4] Generic and Biosimilar Medicines Association (GBSMA). (2022). The Growing Impact of Biosimilars in Europe. (Note: Industry association reports often provide market data and trends.)