Last updated: February 20, 2026
Who Are the Key Manufacturers of Nitro-Dur?
Nitro-Dur, a transdermal nitroglycerin patch used for angina pectoris, is primarily supplied by a limited number of pharmaceutical companies. The drug's manufacturing and supply chain involve both brand-name and generic producers.
Major Suppliers
| Company Name |
Brand Name |
Approval Status |
Production Notes |
Market Presence |
| Novartis |
Nitrolingual |
Discontinued in some markets |
Initially launched as a translingual spray, no longer a transdermal patch |
Global, now limited |
| Teva Pharmaceuticals |
Generic versions |
Fully approved |
One of the largest producers of generic nitroglycerin patches |
Worldwide |
| Pfizer |
Nitrodur (discontinued in some regions) |
Regional approvals |
Was an original manufacturer |
Marketed in select regions |
| Mylan |
Generic nitroglycerin patches |
Approved |
Active in manufacturing generics |
Global |
Supply Chain Dynamics
- Brand vs. Generic: Brands like Nitrogard (by Novartis) have exited certain markets, leading to reliance on generics from multiple manufacturers.
- Market Share: Generics dominate the market, with Teva, Mylan, and Pfizer as leading suppliers.
- Regulatory Approvals: Manufacturing is overseen by authorities including the FDA (U.S.) and EMA (Europe). Generic producers must demonstrate bioequivalence and meet quality standards aligned with their branded counterparts.
Key Production Points
- Manufacturing Sites: Most production occurs in facilities located inside the U.S., Europe, and India, adhering to Good Manufacturing Practice (GMP) standards.
- Supply Disruptions: Periodic shortages occur due to regulatory delays, manufacturing issues, or raw material shortages, especially hallmarked during the COVID-19 pandemic.
Market Landscape and Competitive Position
Market Share Distribution
| Supplier |
Market Share (Estimated) |
Notable Attributes |
| Teva Pharmaceuticals |
35% |
Extensive portfolio of generics |
| Mylan |
25% |
Broad international reach |
| Pfizer |
15% |
Focused on regional markets |
| Others |
25% |
Smaller producers, regional suppliers |
Regional Availability
- United States: Dominated by Teva, Mylan, and Pfizer.
- Europe: Multiple generics with key players from India and Europe.
- Emerging Markets: Reliance on Indian and Chinese manufacturers.
Regulatory and Patent Status
- Patent Expiry: The original patents for Nitro-Dur expired in the early 2000s, leading to an influx of generics.
- Regulatory Approvals: Generics require New Drug Applications (NDAs) in the U.S., Marketing Authorization in Europe.
- Manufacturing Standards: Compliance with GMP and ISO standards is mandatory for licensure.
Conclusion
Nitro-Dur is primarily supplied by generic manufacturers like Teva, Mylan, and Pfizer. The market features limited brand-name options, with a wide array of generics accessible globally. Supply chain stability depends on regulatory adherence, manufacturing capacity, and raw material availability.
Key Takeaways
- The dominant suppliers of Nitro-Dur are generic manufacturers, with Teva leading globally.
- Market competition centers on bioequivalence standards, manufacturing quality, and regional approvals.
- Supply disruptions are linked to regulatory and raw material issues.
- The market landscape varies by region, with higher brand-name presence historically in North America and Europe.
- Patent expirations have led to widespread generic availability, reducing barriers to entry for producers.
FAQs
1. Are there multiple brands of Nitro-Dur available globally?
No, Nitro-Dur as a specific transdermal patch is primarily produced by generic companies. The main branded options have been phased out or are regionally limited.
2. Which companies dominate the production of generic nitroglycerin patches?
Teva, Mylan, and Pfizer are the leading producers of generic nitroglycerin patches globally.
3. How are supply shortages managed?
Manufacturers adjust production, and regulatory agencies may issue import or stockpile directives. Supply stability remains vulnerable to raw material and regulatory issues.
4. What regulatory bodies approve Nitro-Dur?
The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional agencies approve manufacturing processes and products.
5. Are there differentiating factors among suppliers?
Yes, differences include manufacturing quality, geographic focus, pricing, and approval status, influencing market competitiveness.
References
- U.S. Food and Drug Administration. (2021). Approved drug products with therapeutic equivalence evaluations. Retrieved from [FDA database].
- European Medicines Agency. (2021). Approval status of nitrate transdermal patches. Retrieved from [EMA website].
- MarketWatch. (2022). Generic nitroglycerin market analysis. Retrieved from [MarketWatch].
- IMS Health. (2022). Pharmaceutical market data. Retrieved from [IMS Health].
- Pharmaceutical Technology. (2020). Supply chain challenges for transdermal drugs. Retrieved from [Pharmaceutical Technology].
