The manufacturing and distribution of a medication like Dantrium often involves multiple companies, from the original patent holder to the current brand and generic producers. This section details the history and evolution of Dantrium's production and lists the key players involved today.
The Origins of Dantrolene
The story of Dantrium begins in the late 1960s with the synthesis of its active compound, dantrolene sodium. Norwich Pharmacal Co. was the company to secure the original patent for the drug in 1968, following its synthesis by Davis and Snyder. Initially explored for its muscle relaxant properties, it was not until years later that its critical use in treating malignant hyperthermia was discovered, a finding published in 1975.
Current Dantrium Manufacturers
Today, the manufacturing and distribution landscape for Dantrium is segmented. For the North American market, Par Pharmaceutical Inc. produces the branded Dantrium capsules. Separately, Par Sterile Products LLC manufactures the intravenous (IV) formulation, Dantrium IV. Another company, Endo USA, Inc., is listed as a packager for both capsule and injection forms, indicating their role in the distribution chain.
Other Branded and Generic Dantrolene Sodium Products
Beyond the brand name Dantrium, the market for dantrolene sodium includes several other brands and numerous generic equivalents. This is a common occurrence in the pharmaceutical industry once a drug's patent has expired. These alternative products are crucial for ensuring a reliable supply chain and offering options to healthcare providers. For example, the American Society of Health-System Pharmacists (ASHP) lists multiple manufacturers for dantrolene sodium injections.
- Ryanodex: Manufactured by Eagle Pharmaceuticals, this is another branded injectable form of dantrolene sodium, approved for treating and preventing malignant hyperthermia.
- Revonto: Produced by US WorldMeds, LLC, Revonto is another option for intravenous dantrolene sodium.
- Hikma: Hikma Pharmaceuticals USA is a major manufacturer of generic injectable dantrolene sodium.
- Elite Labs Inc. and Impax Labs: These companies were historically listed as manufacturers of generic dantrolene sodium capsules.
The Role of Generic Manufacturers
Generic drugs play a vital role in providing affordable and accessible treatment. The active ingredient, dantrolene sodium, is no longer under patent exclusivity, allowing other companies to produce bioequivalent versions. This competition is beneficial for the market but also makes tracking the exact source of a specific product more complex. A pharmacist or healthcare provider is the best source of information regarding the specific manufacturer of a generic product on hand.
Comparison of Key Dantrolene Sodium Products
| Feature | Dantrium (Capsules) | Dantrium IV (Injection) | Ryanodex (Injection) | Revonto (Injection) |
|---|---|---|---|---|
| Manufacturer | Par Pharmaceutical, Inc. | Par Sterile Products LLC | Eagle Pharmaceuticals, Inc. | US WorldMeds, LLC |
| Formulation | Oral capsules | Intravenous (IV) | Intravenous (IV) | Intravenous (IV) |
| Primary Use | Chronic spasticity | Malignant hyperthermia | Malignant hyperthermia | Malignant hyperthermia |
| Concentration | 25mg, 50mg, 100mg | 20mg per vial | 250mg per vial | 20mg per vial |
| Speed of Use | Slower onset for chronic conditions | Fast-acting for emergency treatment | Fast-acting for emergency treatment | Fast-acting for emergency treatment |
Global Availability
While this guide focuses on the North American market, it's worth noting that Dantrium and its generic equivalents are distributed globally. For instance, Norgine BV markets Dantrium, along with other brand names like Dantamacrin and Dantrolen, in Europe. The presence of multiple international manufacturers ensures that this critical medication is available worldwide.
Conclusion
In summary, the answer to "who makes Dantrium?" involves a chain of companies rather than a single entity. The brand name Dantrium is currently manufactured by Par Pharmaceutical and its subsidiaries for the North American market, with Endo USA also playing a distribution role. The original synthesis and patent belong to Norwich Pharmacal Co., but patent expiration has paved the way for numerous generic manufacturers and other branded competitors like Eagle Pharmaceuticals (Ryanodex) and US WorldMeds (Revonto). This complex manufacturing ecosystem ensures a consistent supply of dantrolene sodium for treating conditions such as chronic spasticity and the life-threatening condition of malignant hyperthermia.
