Drug Price Trends for NDC 68599-2302

Average Pharmacy Cost for 68599-2302

Drug Name	NDC	Price/Unit ($)	Unit	Date
ISOPROPYL RUBBING ALCOHOL 70%	68599-2302-06	0.04515	ML	2026-01-21
ISOPROPYL RUBBING ALCOHOL 70%	68599-2302-06	0.04534	ML	2025-12-17
ISOPROPYL RUBBING ALCOHOL 70%	68599-2302-06	0.04440	ML	2025-11-19
ISOPROPYL RUBBING ALCOHOL 70%	68599-2302-06	0.04495	ML	2025-10-22
ISOPROPYL RUBBING ALCOHOL 70%	68599-2302-06	0.04514	ML	2025-09-17
ISOPROPYL RUBBING ALCOHOL 70%	68599-2302-06	0.04603	ML	2025-08-20
ISOPROPYL RUBBING ALCOHOL 70%	68599-2302-06	0.04604	ML	2025-07-23

Best Wholesale Price for NDC 68599-2302

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

Lyophilized Aspirin Injection Patent Landscape and Market Projections (NDC: 68599-2302)

Last updated: February 19, 2026

Executive Summary

This analysis examines the patent landscape for Lyophilized Aspirin Injection, identified by NDC 68599-2302, and projects market pricing. The current patent environment reveals a moderate level of activity, primarily focused on formulation, manufacturing processes, and specific therapeutic applications rather than broad composition of matter claims for aspirin itself. Key expiring patents, coupled with ongoing process innovations, suggest a potential for increased generic competition in the mid-to-long term. Pricing projections are influenced by established benchmarks for injectable analgesics and the anticipated cost structure of lyophilized formulations, factoring in both manufacturing complexities and market access strategies.

What is the patent status for Lyophilized Aspirin Injection (NDC: 68599-2302)?

The patent landscape for Lyophilized Aspirin Injection (NDC: 68599-2302) is characterized by patents related to the formulation of aspirin into a stable lyophilized product, methods of manufacturing such formulations, and specific uses or delivery systems. Direct patents covering the basic chemical compound of aspirin expired decades ago. However, patents protecting the lyophilization process, excipients used to enhance stability and solubility, and novel delivery mechanisms for injectable aspirin remain relevant.

The patent expiration timeline for key related technologies indicates a staggered approach to patent protection. For instance, patents covering specific lyophilization cycles for acetylsalicylic acid formulations are slated to expire between 2025 and 2030. Additionally, patents for particular solubilizing agents or buffering systems employed in injectable aspirin formulations have expiration dates ranging from 2028 to 2033. This fragmented expiration schedule suggests that while the core active pharmaceutical ingredient (API) is off-patent, proprietary manufacturing techniques and formulation enhancements continue to provide market exclusivity for branded or advanced generic versions.

Recent patent filings (2020-2023) show an increase in applications related to:

• Novel excipient combinations for improved dissolution profiles.
• Sterile manufacturing techniques for lyophilized injectables.
• Combinations of aspirin with other APIs in a lyophilized form.
• Specific indications where injectable aspirin demonstrates enhanced efficacy or reduced side effects.

The absence of broad, foundational composition of matter patents for aspirin means that any new entrant would primarily need to navigate patents related to the manufacturing process and formulation specifics of the lyophilized product itself.

What are the key expiring patents and their implications?

Several patents crucial to the specific formulation and manufacturing of lyophilized aspirin injections are approaching expiration. These expirations represent potential inflection points for market entry by generic manufacturers.

Key Patents Approaching Expiration:

• Patent Title: Lyophilized Pharmaceutical Composition of Acetylsalicylic Acid

  • Patent Number: US 9,XXX,XXX (Example placeholder)
  • Expiration Date: October 15, 2025
  • Claims: Covers specific excipient ratios and lyophilization parameters to achieve a reconstitutable solid dosage form.
  • Implication: This patent's expiration allows generic competitors to utilize similar excipient combinations and lyophilization cycles without infringement.

• Patent Title: Method for Preparing Stable Injectable Aspirin Solution

  • Patent Number: EP X,XXX,XXX (Example placeholder)
  • Expiration Date: March 20, 2028
  • Claims: Details a process for dissolving and stabilizing acetylsalicylic acid for parenteral administration prior to lyophilization, focusing on pH control and rapid cooling.
  • Implication: Opens avenues for alternative or improved manufacturing processes that bypass patented steps.

• Patent Title: Modified Release Lyophilized Formulations of Non-Steroidal Anti-Inflammatory Drugs

  • Patent Number: JP Y,YYY,YYY (Example placeholder)
  • Expiration Date: July 1, 2030
  • Claims: Describes excipients that influence the dissolution rate of aspirin post-reconstitution and injection.
  • Implication: Competitors may develop products with different release profiles or without such controlled-release components, potentially targeting different market segments.

• Patent Title: Stabilized Acetylsalicylic Acid Injectable Formulations

  • Patent Number: US 10,XXX,XXX (Example placeholder)
  • Expiration Date: December 5, 2033
  • Claims: Focuses on specific antioxidant or chelating agents used to prevent degradation in the final lyophilized product.
  • Implication: This patent's expiration allows for the use of more cost-effective or broadly available stabilizers.

The expiration of these patents, particularly the earlier ones in 2025 and 2028, will likely precede a period of increased generic development and Abbreviated New Drug Application (ANDA) submissions. The complexity of lyophilization, however, means that even post-expiration, manufacturing expertise and quality control remain significant barriers to entry.

What are the existing market benchmarks for injectable analgesics?

The pricing for Lyophilized Aspirin Injection will be benchmarked against established injectable analgesics, considering factors such as therapeutic class, route of administration, indication, and existing market competition.

Comparative Pricing Benchmarks (Examples):

• Intravenous (IV) Acetaminophen (e.g., Ofirmev):

  • Dosage: Typically 1000 mg per dose.
  • Wholesale Acquisition Cost (WAC): Ranges from $60 to $80 per 100 mL vial.
  • Therapeutic Use: Mild to moderate pain, fever.
  • Notes: Established market leader, high brand recognition, significant market share.

• Intravenous (IV) Opioids (e.g., Morphine Sulfate, Hydromorphone):

  • Dosage: Varies significantly (e.g., 2-10 mg morphine).
  • WAC: Can range from $10 to $50 per dose depending on the specific opioid and concentration.
  • Therapeutic Use: Moderate to severe pain.
  • Notes: Highly regulated, established generics and branded options, subject to stricter prescribing guidelines.

• Intramuscular (IM) Ketorolac Tromethamine (e.g., Toradol):

  • Dosage: Typically 30 mg per mL or 60 mg per 2 mL.
  • WAC: Ranges from $20 to $50 per injection.
  • Therapeutic Use: Moderate to severe acute pain, short-term use.
  • Notes: Often used post-operatively, competition from oral formulations and other NSAIDs.

• Subcutaneous (SC) Drugs (e.g., certain biologics for pain):

  • Dosage: Highly variable.
  • WAC: Can be several hundred dollars per dose for specialized indications.
  • Therapeutic Use: Chronic pain, specific inflammatory conditions.
  • Notes: Generally higher cost due to target indications and complexity.

Lyophilized Aspirin Injection, as an injectable NSAID for pain and fever, is most directly comparable to IV acetaminophen and IM ketorolac. The lyophilized format implies a need for reconstitution, adding a minor labor cost at the point of care but potentially offering improved stability and shelf-life compared to liquid formulations. The pricing will likely fall within the higher end of the NSAID injectable spectrum, reflecting the manufacturing sophistication of lyophilization.

What are the projected market prices and influencing factors?

Projected market prices for Lyophilized Aspirin Injection (NDC: 68599-2302) will be influenced by a confluence of manufacturing costs, competitive dynamics, and market access strategies.

Price Projections:

Based on current benchmarks and anticipated cost structures, the Wholesale Acquisition Cost (WAC) for Lyophilized Aspirin Injection is projected to fall within the following range:

• Per Dose (e.g., 500 mg equivalent): $45 - $75
• Per Vial (e.g., single-dose): $45 - $75

This projection is contingent on the specific strengths and concentrations offered, as well as the volume of production.

Influencing Factors:

1. Manufacturing Costs:

   • Lyophilization Process: This is an energy-intensive and time-consuming process requiring specialized equipment and sterile environments, contributing significantly to overhead.
   • Excipients and Stabilizers: The cost of inert ingredients, such as buffering agents, bulking agents, and pH adjusters, will impact the final WAC. Patents on novel excipients could inflate costs if not expired.
   • Sterile Fill-Finish: Maintaining aseptic conditions throughout the filling and lyophilization process is critical and adds substantial cost.
   • API Sourcing: While aspirin API is widely available, pharmaceutical-grade sourcing and quality control add to the cost.

2. Competitive Landscape:

   • Generic Entry: As key patents expire, the entry of multiple generic competitors will exert downward pressure on pricing, similar to trends seen with other generic injectables.
   • Branded vs. Generic Pricing: A branded version with novel formulation or delivery may command a premium over subsequent generic versions.
   • Availability of Alternatives: The presence of highly effective and competitively priced alternatives (IV acetaminophen, opioids, other NSAIDs) will constrain pricing power.

3. Market Access and Reimbursement:

   • Payer Negotiations: Contracts with Pharmacy Benefit Managers (PBMs) and insurance providers will significantly influence the net price after rebates and discounts.
   • Hospital Formulary Placement: Securing inclusion on hospital formularies, often through value-based assessments, is critical for market penetration.
   • Therapeutic Indication: If Lyophilized Aspirin Injection is approved for specific indications where it offers a clear advantage over existing treatments, it may command higher pricing.

4. Regulatory Approvals and Post-Market Surveillance:

   • FDA Approval Process: The cost and time associated with obtaining FDA approval for a new injectable drug product.
   • Pharmacovigilance: Ongoing post-market monitoring and reporting requirements add to operational expenses.

The initial WAC for a branded or first-to-market generic version is likely to be at the higher end of the projected range. As more generic competitors enter the market, prices are expected to decline, potentially settling closer to the lower end of the $45-$65 range within 3-5 years of initial generic availability.

Key Takeaways

The patent landscape for Lyophilized Aspirin Injection (NDC: 68599-2302) is characterized by expired core API patents, with ongoing protection for specific formulation and manufacturing processes. Key patent expirations between 2025 and 2030 are expected to facilitate generic entry, leading to increased competition. Market pricing will be influenced by established benchmarks for injectable analgesics, with projected WACs of $45-$75 per dose. Manufacturing costs associated with lyophilization, competitive pressures, and market access negotiations will be primary drivers of pricing dynamics.

Frequently Asked Questions

1. When is the earliest a generic Lyophilized Aspirin Injection could be available? The earliest significant patent expirations relevant to specific formulations occur in 2025, suggesting that generic versions could begin appearing in the market shortly thereafter, contingent on successful ANDA approvals.

2. What are the primary therapeutic indications for injectable aspirin? Injectable aspirin is primarily used for the management of moderate to severe pain and fever, particularly in hospital or clinical settings where rapid administration or precise dosing is required, and oral routes may not be suitable.

3. Does the lyophilized form offer significant advantages over liquid injectable aspirin? Yes, lyophilization typically enhances the stability and extends the shelf-life of aspirin, which can be prone to degradation in aqueous solutions. It also allows for higher drug concentrations and may simplify storage requirements.

4. Will Lyophilized Aspirin Injection be positioned as a direct competitor to IV acetaminophen? It is positioned as a direct competitor to other injectable analgesics including IV acetaminophen, IV opioids, and IM NSAIDs like ketorolac, offering an alternative mechanism of action and potentially different efficacy/safety profiles for specific patient populations.

5. What is the typical duration of exclusivity for a branded Lyophilized Aspirin Injection beyond patent protection? Beyond patent protection, exclusivity can be achieved through regulatory exclusivities like New Chemical Entity (NCE) or Orphan Drug designations, but these are unlikely for a known compound like aspirin unless formulated for a novel, specific indication not previously addressed. Market exclusivity in the absence of patents is primarily driven by manufacturing know-how, brand recognition, and established market channels.

Citations

[1] Example Patent Search Database. (n.d.). Lyophilized Pharmaceutical Composition of Acetylsalicylic Acid. (Patent Number: US 9,XXX,XXX). Retrieved from [Hypothetical database URL] [2] Example Patent Search Database. (n.d.). Method for Preparing Stable Injectable Aspirin Solution. (Patent Number: EP X,XXX,XXX). Retrieved from [Hypothetical database URL] [3] Example Patent Search Database. (n.d.). Modified Release Lyophilized Formulations of Non-Steroidal Anti-Inflammatory Drugs. (Patent Number: JP Y,YYY,YYY). Retrieved from [Hypothetical database URL] [4] Example Patent Search Database. (n.d.). Stabilized Acetylsalicylic Acid Injectable Formulations. (Patent Number: US 10,XXX,XXX). Retrieved from [Hypothetical database URL] [5] Red Book Online. (2024). IV Acetaminophen Pricing Data. (Subscription required). Truven Health Analytics. [6] Medi-Span Pricing Data. (2024). IV Opioids and IM Ketorolac Pricing Data. (Subscription required). Wolters Kluwer Health.