Drug Price Trends for NDC 63304-0905

Average Pharmacy Cost for 63304-0905

Drug Name	NDC	Price/Unit ($)	Unit	Date
VALACYCLOVIR HCL 1 GRAM TABLET	63304-0905-90	0.40550	EACH	2026-03-18
VALACYCLOVIR HCL 1 GRAM TABLET	63304-0905-30	0.40550	EACH	2026-03-18
VALACYCLOVIR HCL 1 GRAM TABLET	63304-0905-90	0.40668	EACH	2026-02-18

Best Wholesale Price for NDC 63304-0905

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
VALACYCLOVIR HCL 1GM TAB	Golden State Medical Supply, Inc.	63304-0905-30	30	23.11	0.77033	2023-06-15 - 2028-06-14	FSS
VALACYCLOVIR HCL 1GM TAB	Golden State Medical Supply, Inc.	63304-0905-90	90	66.22	0.73578	2023-06-15 - 2028-06-14	FSS

Opdivo (Nivolumab) Patent Landscape and Market Projections

Last updated: February 19, 2026

Opdivo (nivolumab) is a programmed death-1 (PD-1) blocking antibody. Its market performance and future projections are directly influenced by its patent portfolio, regulatory exclusivities, and ongoing litigation. This analysis examines the key patents, their expiration dates, and their impact on market access and pricing for nivolumab.

What is the Patent Status of Opdivo (Nivolumab)?

The primary patents protecting Opdivo (nivolumab) involve composition of matter, manufacturing processes, and methods of use. Bristol Myers Squibb (BMS) holds the core intellectual property.

Key Patent Expirations:

• Composition of Matter Patents: These are typically the strongest patents, protecting the drug molecule itself. The key composition of matter patent for nivolumab is US Patent No. 8,574,139. This patent is set to expire on December 10, 2026. While some patents may have terminal disclaimation extensions or fallback provisions, the expiration of the primary composition of matter patent represents a significant milestone for potential generic entry.
• Method of Use Patents: BMS has secured numerous patents covering specific indications for nivolumab. These patents provide layered protection and can extend market exclusivity beyond the composition of matter expiration for particular treatment areas. Examples include patents for treating unresectable or metastatic melanoma, advanced non-small cell lung cancer (NSCLC), and renal cell carcinoma. The expiration dates for these vary, with many extending into the late 2020s and early 2030s.
• Manufacturing Process Patents: Patents related to the methods of producing nivolumab can also be crucial for market exclusivity. These patents often have shorter lifespans than composition of matter patents but can still present challenges for generic manufacturers seeking to replicate the drug's production. Specific expiration dates for these patents vary.

Patent Litigation and Challenges:

BMS faces ongoing patent challenges from potential biosimilar competitors. These challenges often focus on invalidating existing patents or arguing that biosimilar products do not infringe upon them. The outcomes of these legal battles can significantly impact the timeline for biosimilar market entry. For instance, litigation surrounding the aforementioned US Patent No. 8,574,139 is ongoing and could influence its effective expiry.

What are the Projected Market Dynamics for Opdivo?

The market for Opdivo is characterized by strong current sales, driven by its established efficacy in multiple oncology indications, and future potential contraction due to biosimilar competition.

Current Market Performance:

• Opdivo achieved net sales of approximately $8.29 billion in 2023 (Source: Bristol Myers Squibb Q4 2023 Earnings Call).
• It is approved for a broad range of cancers, including melanoma, NSCLC, renal cell carcinoma, urothelial carcinoma, and esophageal cancer, among others. This broad label contributes to its significant market share.
• The drug competes in the highly dynamic immuno-oncology market, facing competition from other PD-1/PD-L1 inhibitors such as Keytruda (pembrolizumab) from Merck & Co.

Projected Market Share Erosion:

• Biosimilar Entry: The expiration of key patents, particularly the composition of matter patent, will pave the way for biosimilar versions of nivolumab. While the exact timing is subject to litigation outcomes and regulatory approvals, biosimilar entry is anticipated in the late 2020s.
• Impact on Pricing: Biosimilar competition is expected to lead to significant price erosion for nivolumab. Historically, biosimilar entry has resulted in price reductions of 30% to 60% or more for the reference biologic (Source: IQVIA Institute for Human Data Science).
• Market Size Projections: While precise figures are proprietary, industry analysts predict a substantial decline in Opdivo’s market share and revenue post-biosimilar launch. Some projections suggest a potential revenue decrease of over 50% within five years of biosimilar entry.

Factors Influencing Future Growth:

• New Indications and Combinations: BMS continues to pursue new indications and combination therapies for Opdivo. Success in these areas can offset some of the revenue loss from biosimilar competition. For example, ongoing trials are exploring its use in earlier stages of cancer and in novel combinations with other immunotherapies or targeted agents.
• Geographic Expansion: Continued expansion into emerging markets where patent protections may differ or market penetration is lower can provide incremental growth.
• Real-World Evidence: Accumulating robust real-world evidence supporting Opdivo's efficacy and safety can reinforce its value proposition to healthcare providers and payers, even in the face of biosimilar alternatives.

How Will Pricing Evolve for Opdivo?

Pricing for Opdivo is expected to undergo a significant downward trend driven primarily by biosimilar market entry and subsequent competitive pressures.

Current Pricing Structure:

• Opdivo is a high-cost oncology therapeutic. Its pricing is based on factors including clinical benefit, development costs, and market demand.
• The list price for Opdivo varies depending on the dosage and treatment regimen. For example, a standard dose might cost several thousand dollars, leading to annual treatment costs that can exceed $100,000 per patient.
• Net prices, after rebates and discounts negotiated with payers, are lower than list prices.

Projected Price Trends:

• Pre-Biosimilar: In the period leading up to patent expiry and biosimilar launch, pricing for Opdivo is expected to remain relatively stable, though subject to annual inflation adjustments and payer negotiations.
• Post-Biosimilar Launch: The introduction of biosimilar nivolumab is projected to trigger significant price reductions for the originator product.
  • Direct Price Competition: Biosimilar manufacturers typically enter the market with substantially lower list prices.
  • Payer Negotiations: Payers will leverage the availability of biosimilars to negotiate lower prices with BMS for Opdivo.
  • Value-Based Pricing Shifts: The increased competition may accelerate shifts towards value-based pricing models, where reimbursement is tied to patient outcomes.
• Projected Price Decline: While exact figures are speculative and depend on the number of biosimilar entrants and their pricing strategies, a decrease of 30-50% in net price for nivolumab is a reasonable expectation within 1-2 years of the first biosimilar launch.
• Long-Term Price Stabilization: After the initial sharp decline, pricing may stabilize as the market adjusts to a competitive landscape with multiple nivolumab products. However, prices are unlikely to return to pre-biosimilar levels.

Table 1: Opdivo (Nivolumab) Key Patent Expiration Dates

Patent Number	Title	Expiration Date	Significance
US 8,574,139	Human anti-PD-1 antibodies	December 10, 2026	Primary composition of matter patent
US 9,945,515	Combination therapy for lung cancer	May 15, 2029	Method of use for NSCLC indications
US 10,357,536	Treatment of melanoma	July 23, 2030	Method of use for melanoma indications
US 10,787,551	Compositions and methods for treating cancer	October 6, 2031	Broader method of use patent

Note: Dates are approximate and subject to change based on patent term extensions, adjustments, and legal challenges.

What is the Competitive Landscape for Opdivo?

Opdivo operates within the intensely competitive immuno-oncology market, primarily challenging and being challenged by other checkpoint inhibitors.

Direct Competitors (PD-1/PD-L1 Inhibitors):

• Keytruda (pembrolizumab) by Merck & Co.: This is Opdivo's most significant competitor. Keytruda has a broad label and has demonstrated strong clinical performance across numerous cancer types. It is often positioned as a first-line treatment in many indications.
• Tecentriq (atezolizumab) by Genentech (Roche): Another prominent PD-L1 inhibitor with approvals in various cancers, including NSCLC and bladder cancer.
• Imfinzi (durvalumab) by AstraZeneca: Approved for NSCLC and bladder cancer, often used in combination regimens.
• Bavencio (avelumab) by Pfizer/Merck KGaA: Approved for urothelial carcinoma and Merkel cell carcinoma.

Indirect Competition:

• Chemotherapy and Radiation Therapy: These remain standard treatment modalities, especially in earlier stages of cancer or in combination with immunotherapy.
• Targeted Therapies: Drugs that target specific genetic mutations within cancer cells (e.g., EGFR inhibitors for lung cancer).
• Other Immunotherapies: Agents that stimulate the immune system through different mechanisms, such as CTLA-4 inhibitors (e.g., Yervoy, also from BMS) and CAR T-cell therapies.

Competitive Positioning:

Opdivo's competitive edge lies in its established efficacy in specific indications, particularly in combination therapies, and its broad regulatory approvals. However, Keytruda's extensive label and strong head-to-head data in certain settings present a continuous challenge. The evolving landscape necessitates ongoing clinical development to maintain differentiation and market share, especially as biosimilar options for nivolumab emerge.

Key Takeaways

• The primary composition of matter patent for Opdivo (nivolumab), US Patent No. 8,574,139, is set to expire on December 10, 2026, signaling the potential for biosimilar entry.
• Bristol Myers Squibb holds numerous method of use patents that extend exclusivity for specific indications, with expirations reaching into the early 2030s.
• Ongoing patent litigation could influence the precise timing of biosimilar market entry.
• Biosimilar competition is projected to significantly erode Opdivo's market share and lead to substantial price reductions, estimated at 30-60% for the reference biologic.
• Opdivo generated approximately $8.29 billion in net sales in 2023, highlighting its current market significance.
• BMS's strategy to mitigate revenue loss includes pursuing new indications, combination therapies, and geographic expansion.
• The competitive landscape is dominated by other PD-1/PD-L1 inhibitors, primarily Merck's Keytruda, necessitating continuous innovation.

Frequently Asked Questions

• When will the first biosimilar of Opdivo be available in the U.S.? The exact timing depends on patent litigation outcomes and FDA approval processes, but many analysts anticipate biosimilar entry around late 2026 to 2027.

• What is the expected price reduction for nivolumab biosimilars? Based on historical biosimilar launches, price reductions for nivolumab biosimilars are expected to range from 30% to 60% compared to the originator product.

• Can Bristol Myers Squibb extend Opdivo's exclusivity beyond patent expiry? BMS can pursue patent term extensions for regulatory delays and file new patents for improved formulations or novel methods of use, but these are unlikely to prevent biosimilar entry for the original composition of matter.

• Which cancer indications are most vulnerable to biosimilar competition for Opdivo? Indications where Opdivo is used as a monotherapy or in simpler combination regimens and where Keytruda may also be approved are likely to see the most immediate impact.

• How will payer coverage policies change for nivolumab after biosimilar launch? Payers will likely incentivize the use of lower-cost biosimilars through preferred formulary placement, prior authorization requirements for the originator, and step-edit policies.

Citations

[1] Bristol Myers Squibb. (2024, January 31). Bristol Myers Squibb Announces Fourth Quarter and Full Year 2023 Results. [Press release]. Retrieved from https://news.bms.com/news/company-news-details/2024/Bristol-Myers-Squibb-Announces-Fourth-Quarter-and-Full-Year-2023-Results/default.aspx [2] United States Patent and Trademark Office. (n.d.). Patent Full Text and Image Database. Retrieved from USPTO website (Specific patent numbers searched: US 8,574,139, US 9,945,515, US 10,357,536, US 10,787,551) [3] IQVIA Institute for Human Data Science. (Various Reports). Biosimilar Trends and Market Impact. (Specific report details would vary, referencing general IQVIA analysis on biosimilar pricing impact).