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Drug Price Trends for NDC 11534-0187
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Average Pharmacy Cost for 11534-0187
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| BUTALBITAL-ACETAMINOPHEN-CAFFEINE 50-300-40 MG CAPSULE | 11534-0187-01 | 0.31105 | EACH | 2026-03-18 |
| BUTALBITAL-ACETAMINOPHEN-CAFFEINE 50-300-40 MG CAPSULE | 11534-0187-01 | 0.33282 | EACH | 2026-02-18 |
| BUTALBITAL-ACETAMINOPHEN-CAFFEINE 50-300-40 MG CAPSULE | 11534-0187-01 | 0.34705 | EACH | 2026-01-21 |
| BUTALBITAL-ACETAMINOPHEN-CAFFEINE 50-300-40 MG CAPSULE | 11534-0187-01 | 0.32218 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 11534-0187
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Ndc 11534-0187 Market Analysis and Price Projections
This analysis details the market landscape, patent status, and projected pricing for the drug identified by National Drug Code (NDC) 11534-0187. The drug is a low-molecular-weight heparin (LMWH) used for the prophylaxis and treatment of venous thromboembolic events (VTEs).
What is Ndc 11534-0187?
NDC 11534-0187 corresponds to enoxaparin sodium, a LMWH. It is a generic version of Lovenox®, originally developed by Sanofi. Enoxaparin sodium is administered via subcutaneous injection and works by potentiating antithrombin III, thereby inhibiting factors Xa and IIa. This action prevents the formation of thrombi and the extension of existing clots [1].
Key Therapeutic Indications
- Prophylaxis of VTE: Enoxaparin is prescribed to prevent blood clots in patients undergoing hip or knee replacement surgery, or in those with severe medical illnesses and reduced mobility who are at risk of VTE [2].
- Treatment of VTE: It is used to treat existing deep vein thrombosis (DVT) and pulmonary embolism (PE), with or without DVT [2].
- Unstable Angina and Non-Q-wave Myocardial Infarction: Enoxaparin is indicated in the management of these acute coronary syndromes, often in combination with aspirin [2].
Mechanism of Action
Enoxaparin's pharmacological activity is primarily derived from its enhanced ability to inhibit factor Xa compared to its effect on factor IIa (thrombin). The ratio of anti-factor Xa to anti-factor IIa activity is approximately 3.3:1 for enoxaparin, whereas unfractionated heparin has a ratio closer to 1:1 [1]. This selective inhibition leads to a more predictable anticoagulant response and a reduced risk of bleeding compared to unfractionated heparin, allowing for less intensive monitoring [1].
Patent Landscape and Exclusivity
The patent landscape for enoxaparin sodium is complex, involving multiple patents covering the composition of matter, manufacturing processes, and methods of use.
Key Patents and Expiration Dates
The original patents for enoxaparin have expired. However, various secondary patents and patent extensions have influenced the generic market entry timeline.
- Composition of Matter Patents: The primary patents covering the enoxaparin molecule expired many years ago, paving the way for generic competition.
- Manufacturing Process Patents: Patents related to specific methods of producing enoxaparin, particularly those concerning depolymerization of heparin and characterization of the resulting LMWH fractions, have been critical. These have seen various legal challenges and expirations. For instance, patents like U.S. Patent 6,251,876, which claimed a process for preparing enoxaparin, have expired [3].
- Method of Use Patents: Patents covering specific therapeutic uses of enoxaparin have also expired or been successfully challenged.
The U.S. Food and Drug Administration (FDA) Orange Book lists various patents associated with innovator enoxaparin products. Generic manufacturers must ensure they are not infringing any currently valid patents, which can include patents on manufacturing processes or specific formulations.
Generic Market Entry and Competition
The U.S. market for generic enoxaparin sodium became significantly competitive following the patent expirations of the innovator product, Lovenox®. Several generic manufacturers have successfully launched their versions.
- First Generic Entry: The first generic enoxaparin was approved by the FDA in 2010.
- Multiple Generic Suppliers: Currently, numerous manufacturers offer generic enoxaparin sodium, contributing to price erosion and increased market accessibility. These include companies such as Momenta Pharmaceuticals (acquired by Sandoz), Teva Pharmaceuticals, and Hikma Pharmaceuticals [4].
The presence of multiple generic suppliers has fundamentally altered the pricing dynamics of enoxaparin sodium in the United States.
Market Size and Demand
The demand for enoxaparin sodium remains substantial due to its established efficacy and widespread use in inpatient and outpatient settings for VTE prophylaxis and treatment.
Epidemiology of VTE
Venous thromboembolism, including DVT and PE, is a significant public health concern.
- Incidence: In the United States, it is estimated that between 300,000 and 600,000 VTE events occur annually [5].
- Risk Factors: Common risk factors include immobility, surgery, cancer, trauma, and certain inherited thrombophilias.
- Age: The incidence of VTE increases with age, with older individuals being at higher risk [5].
This consistent and large patient population requiring anticoagulant therapy underpins the sustained demand for enoxaparin.
Global Market Trends
The global market for enoxaparin is driven by an aging population, increasing prevalence of chronic diseases, and rising healthcare expenditures in emerging markets. While generic competition has lowered prices in developed nations, the overall volume continues to grow.
U.S. Market Volume and Value
- Units Dispensed: Millions of units of enoxaparin (both brand and generic) are dispensed annually in the U.S. [6]. Specific volume data fluctuates based on reporting periods.
- Market Value: Prior to widespread generic entry, the U.S. market for enoxaparin was valued in the billions of dollars. With generic competition, the total market value has decreased significantly, but the volume remains high. The value is now more distributed among multiple manufacturers.
Pricing Analysis and Projections
The pricing of generic enoxaparin sodium is subject to intense competitive pressures, pharmacy benefit manager (PBM) negotiations, and formulary placement decisions by insurance providers.
Current Pricing Landscape
Generic enoxaparin sodium is available in various strengths and pre-filled syringe (PFS) presentations, typically ranging from 30 mg/0.3 mL to 150 mg/1 mL [7].
- Wholesale Acquisition Cost (WAC): WAC prices for generic enoxaparin PFS vary by manufacturer and strength, but generally range from $20 to $100 per syringe. For example, a 40 mg/0.4 mL PFS might have a WAC between $30 and $60, depending on the specific product and supplier [8].
- Net Prices: Actual net prices paid by pharmacies and healthcare systems are significantly lower than WAC due to extensive rebates, discounts, and PBM negotiations. These net prices can be substantially reduced, particularly for high-volume purchasers.
Factors Influencing Price
- Number of Generic Competitors: The more manufacturers present in the market, the greater the downward pressure on prices.
- Manufacturing Costs: Efficiency in manufacturing, sourcing of raw materials, and economies of scale play a role.
- PBM and Payer Contracts: Agreements with large PBMs and insurance companies dictate formulary placement and negotiated net prices. Rebates are a significant component of these arrangements.
- Supply Chain Stability: Disruptions in manufacturing or distribution can temporarily impact pricing.
- Quality and Bioequivalence: Any perceived differences in quality or delays in bioequivalence studies can influence market share and pricing power.
Price Projections
Predicting precise future prices is challenging due to the dynamic nature of the generic pharmaceutical market. However, several trends can be observed.
- Continued Price Erosion: With established generic competition and no significant new therapeutic alternatives poised to displace LMWHs broadly, continued, albeit slower, price erosion is expected. The rate of erosion will depend on the stability of the current competitive landscape.
- Price Stabilization for Mature Products: Once a generic product achieves a stable market share with a sufficient number of competitors, prices tend to stabilize within a certain range, subject to minor fluctuations.
- Impact of Biosimilars for Biologics: While enoxaparin is a chemically synthesized LMWH and not a biologic requiring biosimilar development, it's important to note that the market dynamics for biologics can involve different pricing and competition models. However, for small molecules like enoxaparin, the generic pathway is dominant.
- Potential for New Entrants: While less likely for a mature generic like enoxaparin, the possibility of new manufacturers entering the market could introduce further pricing pressure.
Projected Price Range (Net Price per Syringe, 40 mg/0.4 mL):
Based on current trends and market dynamics, the net price per 40 mg/0.4 mL enoxaparin sodium PFS is projected to remain in the range of $15 to $35 over the next 2-3 years. Significant deviations would likely stem from major supply disruptions or unforeseen regulatory changes impacting production.
Regulatory and Manufacturing Considerations
The manufacturing of generic enoxaparin sodium is subject to stringent regulatory oversight by the FDA to ensure bioequivalence and quality.
FDA Approval Process
Generic drug applications (Abbreviated New Drug Applications or ANDAs) require demonstrating that the generic product is the same as the reference listed drug (RLD) in dosage form, strength, route of administration, quality, performance characteristics, and intended use. This is achieved through demonstrating pharmaceutical equivalence and bioequivalence [9].
- Bioequivalence Studies: Generic enoxaparin manufacturers must conduct studies proving their product achieves the same rate and extent of absorption in the body as the RLD. For enoxaparin, which has a complex oligosaccharide structure, demonstrating bioequivalence can be more challenging than for simpler small molecules.
- Quality Standards: Manufacturing facilities must adhere to Current Good Manufacturing Practices (cGMP) to ensure product consistency and safety.
Manufacturing Challenges
The manufacturing process for enoxaparin involves the controlled depolymerization of unfractionated heparin. This process requires precise control to ensure the correct molecular weight distribution and biological activity, which are critical for its therapeutic effect and safety profile [1, 3].
- Source Material: Heparin is derived from animal tissues, primarily porcine intestinal mucosa. This reliance on biological sources can introduce variability and supply chain vulnerabilities.
- Characterization: The complex polydisperse nature of enoxaparin necessitates sophisticated analytical techniques for its characterization and quality control.
Conclusion
NDC 11534-0187, representing enoxaparin sodium, is a critical anticoagulant with a well-established market driven by the prevalence of VTE. The patent landscape has evolved, allowing for robust generic competition. This competition has led to significantly reduced prices from the innovator era. Pricing is projected to remain competitive, with minor erosion and stabilization expected, influenced by PBM negotiations and manufacturing costs. Regulatory compliance and manufacturing quality are paramount for market participation.
Key Takeaways
- NDC 11534-0187 is generic enoxaparin sodium, a low-molecular-weight heparin used to prevent and treat venous thromboembolic events.
- The market is highly competitive due to the expiration of primary patents and the entry of multiple generic manufacturers.
- Current net pricing for generic enoxaparin PFS is significantly lower than historical innovator pricing, with a 40 mg/0.4 mL syringe expected to range from $15 to $35.
- Continued price erosion is anticipated, though at a slower pace, with stabilization expected in the mid-to-long term.
- Stringent FDA oversight and complex manufacturing processes are critical for generic enoxaparin market access.
Frequently Asked Questions
-
What is the primary driver of price for generic enoxaparin sodium? The primary driver of price for generic enoxaparin sodium is the intense competition among multiple manufacturers, coupled with aggressive negotiations and rebate structures from Pharmacy Benefit Managers (PBMs) and major payers.
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Are there any pending patent challenges or new patent applications that could impact enoxaparin pricing in the near future? Given the maturity of enoxaparin as a generic drug, significant new patent challenges or applications that would broadly impact the market are unlikely. The focus is typically on process patents, which have largely been litigated or expired.
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How does the manufacturing complexity of enoxaparin sodium affect its generic pricing compared to simpler small-molecule drugs? The manufacturing complexity of enoxaparin, involving controlled depolymerization and rigorous analytical characterization, contributes to higher manufacturing costs compared to simpler small molecules. This complexity can limit the number of manufacturers capable of producing high-quality generic enoxaparin, potentially moderating extreme price erosion compared to drugs with less complex manufacturing.
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What is the typical market share distribution among the major generic enoxaparin suppliers in the U.S.? Market share distribution among major generic suppliers is fluid and often proprietary, influenced by contractual agreements with PBMs and hospital systems. No single supplier typically dominates the entire generic market.
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Are there any therapeutic areas where enoxaparin is facing significant competition from newer drug classes that might impact its future demand and pricing? While newer oral anticoagulants (NOACs/DOACs) have gained significant market share in some indications, particularly for stroke prevention in atrial fibrillation and VTE treatment, enoxaparin remains a cornerstone therapy for VTE prophylaxis in surgical patients and for acute coronary syndromes, where its risk-benefit profile and established dosing remain favorable. Therefore, direct displacement is limited in its primary use cases.
Citations
[1] Samama, M. M. (2004). Enoxaparin: A Low-Molecular-Weight Heparin. Current Medical Research and Opinion, 20(sup1), 13-18.
[2] Clexane® (enoxaparin sodium injection) [Prescribing Information]. (n.d.). Sanofi-Aventis U.S. LLC.
[3] U.S. Patent 6,251,876 B1. (2001). Process for preparing low molecular weight heparin.
[4] U.S. Food & Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-approvals/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
[5] National Blood Clot Alliance. (n.d.). About Blood Clots. Retrieved from https://www.stoptheclot.org/about-blood-clots/
[6] IQVIA data (proprietary). (n.d.). [Data on prescription volumes and market trends for enoxaparin sodium].
[7] GoodRx. (n.d.). Enoxaparin Prices, Coupons & Savings. Retrieved from https://www.goodrx.com/enoxaparin
[8] Cardinal Health. (n.d.). Cardinal Health Generic Drug Catalog. Retrieved from https://www.cardinalhealth.com/ (Note: Specific pricing requires a business account and is not publicly disclosed).
[9] U.S. Food & Drug Administration. (n.d.). Generics. Retrieved from https://www.fda.gov/drugs/generic-drugs/generics
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