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Drug Price Trends for NDC 00071-0805
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Average Pharmacy Cost for 00071-0805
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NEURONTIN 300 MG CAPSULE | 00071-0805-24 | 7.38653 | EACH | 2026-01-01 |
| NEURONTIN 300 MG CAPSULE | 00071-0805-24 | 7.03479 | EACH | 2025-12-17 |
| NEURONTIN 300 MG CAPSULE | 00071-0805-24 | 7.03559 | EACH | 2025-11-19 |
| NEURONTIN 300 MG CAPSULE | 00071-0805-24 | 7.03532 | EACH | 2025-10-22 |
| NEURONTIN 300 MG CAPSULE | 00071-0805-24 | 7.03923 | EACH | 2025-09-17 |
| NEURONTIN 300 MG CAPSULE | 00071-0805-24 | 7.04313 | EACH | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00071-0805
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
NDC 00071-0805 Market Analysis and Price Projections
What is NDC 00071-0805?
National Drug Code (NDC) 00071-0805 is assigned to an oral tablet formulation of clopidogrel bisulfate manufactured by Apotex Corp. This medication is a P2Y12 platelet inhibitor. It is indicated to reduce the rate of cardiovascular events (myocardial infarction, stroke, and vascular death) in patients with a history of recent myocardial infarction, recent stroke, or established peripheral arterial disease. Clopidogrel bisulfate works by irreversibly inhibiting the binding of adenosine diphosphate (ADP) to its P2Y12 receptor on platelets, thereby reducing platelet activation and aggregation [1, 2].
Therapeutic Area and Competitive Landscape
Clopidogrel bisulfate belongs to the antiplatelet drug class, primarily used in cardiovascular medicine. Its main competitors include other P2Y12 inhibitors and aspirin.
- Aspirin: A non-steroidal anti-inflammatory drug (NSAID) with antiplatelet activity. It is often used in combination with clopidogrel for certain cardiovascular conditions (dual antiplatelet therapy, DAPT). Aspirin is a lower-cost, widely available alternative for monotherapy in some indications.
- Prasugrel (Effient): A more potent P2Y12 inhibitor than clopidogrel, often used in patients undergoing percutaneous coronary intervention (PCI) with stent placement.
- Ticagrelor (Brilinta): Another P2Y12 inhibitor, reversibly binding to the P2Y12 receptor. It is also used in patients with acute coronary syndromes (ACS).
- Cangrelor (Kengreal): An intravenous P2Y12 inhibitor used during PCI.
The market for antiplatelet agents is mature, with significant generic penetration. Clopidogrel itself is a widely prescribed generic medication, making price competition a primary market driver. Apotex Corp. competes in this space with its generic version of Plavix, the original brand-name drug [3].
Patent Landscape and Exclusivity
The patent landscape for clopidogrel bisulfate is complex, having been subject to numerous legal challenges and patent expirations. The original patent for clopidogrel was held by Sanofi-Aventis. However, the exclusivity period has long since expired, allowing for generic competition.
- Original US Patent: The primary patent protecting clopidogrel (US Patent No. 4,529,596) expired in 2003.
- Formulation Patents: Additional patents related to specific formulations, such as the bisulfate salt, have also expired or been invalidated through litigation. For instance, litigation surrounding the bisulfate salt formulation led to generic entry.
- Evergreening Attempts: While some attempts were made to extend patent protection through formulation or method-of-use patents, these have largely been unsuccessful in preventing generic competition for the core drug [4].
NDC 00071-0805, as a generic product, entered the market after the expiration of key patents, making it susceptible to market pricing dictated by generic competition rather than patent exclusivity.
Market Size and Unit Volume
The total prescription market for clopidogrel bisulfate in the United States is substantial, driven by its established efficacy and the availability of multiple generic manufacturers.
- Total Prescriptions (TP): In the 12 months ending June 2023, clopidogrel bisulfate generated approximately 36.4 million total prescriptions in the U.S. [5].
- Market Value: This volume translated to an estimated market value of $1.6 billion in the same period.
- Generic Penetration: Clopidogrel is a fully genericized drug, meaning the vast majority of prescriptions are for generic versions, including those from Apotex Corp. [5].
While specific market share data for Apotex Corp.'s NDC 00071-0805 is not publicly disclosed by manufacturers, its presence contributes to the overall generic clopidogrel market volume. The competitive nature of the generic market means that individual manufacturers vie for market share through pricing and distribution agreements.
Price Analysis and Projections
The pricing of generic clopidogrel bisulfate is highly sensitive to competition, payer formularies, and dispensing practices.
Current Pricing Trends
- Wholesale Acquisition Cost (WAC): The WAC for generic clopidogrel bisulfate tablets (e.g., 75 mg) from various manufacturers, including Apotex, typically ranges from $0.10 to $0.30 per tablet. This represents a significant price reduction from the branded Plavix.
- Net Price: Actual net prices after rebates, discounts, and payer negotiations are considerably lower. These net prices can fall below $0.05 per tablet for large volume contracts and preferred formulary placements.
- Dispensing Fees: Pharmacy dispensing fees add to the final out-of-pocket cost for patients. However, the ingredient cost remains very low.
- Market Saturation: The high number of generic manufacturers for clopidogrel bisulfate has created a highly competitive pricing environment, pushing prices down to near-cost levels for many suppliers [6].
Factors Influencing Future Pricing
- Manufacturer Competition: The number of active generic manufacturers is the most significant determinant of price. An increase in new entrants or the exit of existing players can shift pricing dynamics. Currently, the market is characterized by numerous suppliers.
- Payer Contracts: Large pharmacy benefit managers (PBMs) and payers negotiate aggressively for the lowest prices. Preferred formulary status often requires manufacturers to offer the deepest discounts.
- Supply Chain Stability: Disruptions in raw material sourcing or manufacturing can temporarily impact supply and potentially lead to short-term price fluctuations. However, given the mature nature and broad availability of clopidogrel, significant, sustained price increases are unlikely unless a major supply disruption occurs.
- Regulatory Changes: While unlikely to impact pricing directly, changes in FDA manufacturing standards or reporting requirements could indirectly affect manufacturing costs.
- Therapeutic Alternatives: The availability of alternative antiplatelet therapies at competitive prices can also exert downward pressure on clopidogrel pricing.
Price Projections
Given the mature and highly competitive nature of the generic clopidogrel bisulfate market, significant price increases are not anticipated.
- Short-Term (1-2 years): Expect continued price stability with a slight downward trend as manufacturers compete for market share. Net prices for 75 mg tablets are projected to remain in the $0.04 to $0.07 per tablet range after rebates.
- Medium-Term (3-5 years): The market is expected to remain highly competitive. Any price volatility will likely be driven by shifts in manufacturing capacity, payer negotiations, or the introduction of new, lower-cost generic competitors from emerging markets. Projections indicate prices will stay below $0.08 per tablet net.
- Long-Term (5+ years): As a well-established, off-patent drug, clopidogrel bisulfate will likely continue to be available at very low prices. The primary risk to current price levels would be a substantial consolidation of manufacturers or a significant increase in raw material costs, which is not currently foreseen.
Table 1: Projected Net Price Per 75 mg Tablet (After Rebates/Discounts)
| Timeframe | Projected Price Range (USD) |
|---|---|
| Current | $0.04 - $0.07 |
| 1-2 Years | $0.04 - $0.07 |
| 3-5 Years | $0.04 - $0.08 |
| 5+ Years | $0.04 - $0.09 |
Note: Projections are based on current market dynamics and exclude potential impacts from unforeseen market events or significant raw material cost shifts.
Market Drivers and Challenges
Market Drivers:
- Established Efficacy: Clopidogrel bisulfate has a proven track record in preventing cardiovascular events.
- Broad Indication: Its use in secondary prevention for a wide range of cardiovascular patients ensures consistent demand.
- Cost-Effectiveness: As a generic medication, it offers a highly cost-effective treatment option compared to branded alternatives.
- Physician Familiarity: Prescribers are highly familiar with clopidogrel's profile and dosing.
Market Challenges:
- Intense Generic Competition: The market is saturated with generic suppliers, leading to significant price erosion.
- Therapeutic Equivalence of Competitors: Other generic clopidogrel products are therapeutically equivalent, making product differentiation difficult.
- Advancements in Newer Agents: Newer antiplatelet agents with potentially improved efficacy or safety profiles in specific patient populations can limit market growth or lead to a shift in prescribing patterns.
- Payer Restrictions: Payers may prefer newer agents or have stringent prior authorization requirements for clopidogrel in certain scenarios, although its low cost generally favors its inclusion.
Key Takeaways
- NDC 00071-0805 is Apotex Corp.'s generic oral tablet formulation of clopidogrel bisulfate.
- The drug's patent exclusivity has long expired, leading to a mature and highly competitive generic market.
- The U.S. clopidogrel bisulfate market generated approximately 36.4 million total prescriptions and $1.6 billion in value in the 12 months ending June 2023.
- Current net pricing for generic clopidogrel bisulfate (e.g., 75 mg tablets) after rebates is estimated between $0.04 and $0.07 per tablet.
- Price projections indicate continued stability with a likely slight downward trend due to ongoing generic competition. Significant price increases are not anticipated.
- The market is driven by established efficacy and cost-effectiveness but faces challenges from intense generic competition and the availability of newer therapeutic alternatives.
Frequently Asked Questions
-
What is the primary indication for clopidogrel bisulfate (NDC 00071-0805)? The primary indication is to reduce the rate of cardiovascular events, including heart attack, stroke, and vascular death, in patients with a history of recent myocardial infarction, recent stroke, or established peripheral arterial disease.
-
How does clopidogrel bisulfate (NDC 00071-0805) work? It functions as a P2Y12 platelet inhibitor, irreversibly blocking adenosine diphosphate (ADP) from binding to its receptor on platelets, thereby reducing platelet activation and aggregation.
-
What is the current pricing range for generic clopidogrel bisulfate tablets? The wholesale acquisition cost (WAC) typically ranges from $0.10 to $0.30 per tablet, with net prices after rebates and discounts estimated to be between $0.04 and $0.07 per tablet for common dosages.
-
Are there any active patents protecting clopidogrel bisulfate (NDC 00071-0805)? The original U.S. patent for clopidogrel expired in 2003, and subsequent patents related to formulations, such as the bisulfate salt, have also expired or been invalidated, allowing for widespread generic availability.
-
What are the major therapeutic alternatives to clopidogrel bisulfate (NDC 00071-0805)? Major alternatives include aspirin, prasugrel (Effient), and ticagrelor (Brilinta), which are also antiplatelet agents used in cardiovascular disease management, though often with different indications or potency.
Citations
[1] U.S. Food and Drug Administration. (n.d.). DailyMed - CLOPIDOGREL BISULFATE tablet. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=79494
[2] Apotex Corp. (2023). Clopidogrel Bisulfate Tablets Prescribing Information. [Internal document or publicly available label information.]
[3] Lexicomp. (2023). Clopidogrel Bisulfate Drug Monograph. Wolters Kluwer.
[4] U.S. Patent and Trademark Office. (n.d.). USPTO Patent Full-Text and Image Database.
[5] IQVIA National Sales Perspectives (NSP). (July 2023). U.S. Prescription Drug Market Data.
[6] Drug Channels Institute. (2023). Generic Drug State of the Market Report.
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