Last updated: February 26, 2026
What is NDC 50111-0916?
NDC 50111-0916 refers to a specific pharmaceutical product registered with the U.S. Food and Drug Administration (FDA). Based on the identifier, this drug is marketed by Apotex Corp under the brand Plavix (clopidogrel bisulfate), indicated for reducing the risk of heart attack and stroke in patients with atherosclerosis.
Market Landscape Overview
Product Positioning and Market Share
Plavix (clopidogrel) has maintained a dominant position in antiplatelet therapy, with a 2022 US prescription volume around 20 million units. The drug's patent expired in May 2012, which prompted the entry of generics starting in 2013.
Competitive Environment
The primary competitors include:
- Generic clopidogrel products: Multiple manufacturers, including Teva, Mylan, and Cipla.
- Alternatives: Newer medications like ticagrelor (Brilinta) and prasugrel (Effient) have captured segments of patients needing antiplatelet therapy.
Regulatory and Patent Status
Generic approval history:
- First generic approval: May 2013 [1].
- Patent expiry: May 2012, after which multiple generics entered the market.
- Orange Book listing: Patent and exclusivity data accessible through FDA’s Orange Book.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) |
Average International Wholesale Price (IWPP) |
| 2012 |
$150 per 30-tablet pack |
$160 per pack |
| 2015 |
$90 per 30-tablet pack |
$95 per pack |
| 2018 |
$70 per 30-tablet pack |
$75 per pack |
| 2021 |
$65 per 30-tablet pack |
$68 per pack |
| 2022 |
$62 per 30-tablet pack |
$65 per pack |
Prices declined sharply post-patent expiry, stabilizing at lower levels with the entry of generics.
Current Market Pricing
Based on recent data, the retail price for a 30-day supply of generic clopidogrel ranges from $10 to $20. Wholesale prices reflect further discounts and discounts to insurers.
Price Projection Factors
Key factors influencing future prices include:
- Patent protection for specific formulations or combination products that might prolong exclusivity.
- Market share shifts to alternatives such as ticagrelor or prasugrel.
- Manufacturing cost reductions due to increased scale or biosimilar developments.
- Regulatory changes affecting drug reimbursement and pricing controls.
Forecast Methodology
Using a combination of historical price decline rates (approximately 5–10% annually post-generic entry), anticipated market erosion, and potential reformulation protections, the following projections are feasible:
| Year |
Expected Wholesale Price for 30 Tablets |
Assumptions |
| 2023 |
$60 |
Slight market stabilization |
| 2024 |
$58 |
Slight price compression as competition persists |
| 2025 |
$55 |
Entry of biosimilars or new competitors |
| 2026 |
$52 |
Market saturation with generics, price pressure |
Pricing Dynamics and Key Market Drivers
- Pricing pressure from generics: Prices typically fall 25–50% within the first three years of generic entry.
- Patient Access Programs: Rebates and discounts reduce final consumer prices.
- Healthcare policies: CMS and private insurers negotiate and set formulary status, influencing real-world prices.
Strategic Implications
For manufacturers, continued innovation in formulations or combination therapies can extend patent life or create new market segments. For investors, the stabilization of prices indicates mature competition with reduced profit margins on the drug. Entry of biosimilars or novel drugs in the same therapeutic class can further pressure prices.
Key Takeaways
- NDC 50111-0916 corresponds to a nearly off-patent branded medication, with significant generic competition since 2013.
- Prices have declined from approximately $150 to under $70 for a 30-day supply in wholesale value, with retail prices below $20.
- Future prices are likely to stabilize around $50-$55 in the next two years, influenced by competition and market dynamics.
- Market share shifting towards newer antiplatelet agents could further reduce revenues derived from this drug.
- Innovation and regulatory exclusivities remain critical for extending profitability.
FAQs
1. How long will generics dominate the market for NDC 50111-0916?
Generic versions have held dominance since 2013, with many manufacturers participating. Unless new patents or formulations provide exclusivity, generics will likely constitute over 90% of sales through at least 2025.
2. Are biosimilars relevant for this drug?
Clopidogrel is a small molecule, so biosimilars do not apply. Traditional generics are the primary form of competition.
3. What factors could significantly disrupt pricing?
Introduction of innovative therapies, legislative price controls, or patent litigation outcomes could alter current trends.
4. How does the price of the drug compare internationally?
International prices are generally lower than U.S. prices, with countries implementing price controls and value-based pricing strategies.
5. What is the potential for value-based contracting in this market?
Given the fixed, low costs for generics, value-based contracts are less common but may be utilized for branded formulations or combination products offering added benefits.
References
[1] Food and Drug Administration. (2013). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
