Last updated: July 29, 2025
Introduction: Overview of DIASTAT
DIASTAT is a pharmaceutical formulation primarily comprising diastat (diazepam rectal gel). It is used as an emergency treatment for seizure episodes, particularly in patients with epilepsy. The drug’s rapid onset of action makes it critical for controlling acute seizure activity, especially in pediatric and adult populations with refractory epilepsy. Due to its importance and specialized formulation, DIASTAT’s supply chain comprises a limited number of manufacturers and authorized suppliers, often under strict regulatory oversight.
Manufacturers and Primary Suppliers
1. Valeant Pharmaceuticals (now part of Bausch Health)
For many years, Valeant Pharmaceuticals was the primary manufacturer responsible for DIASTAT in the United States. Its formulation, under the brand name DIASTAT, was approved by the U.S. Food and Drug Administration (FDA) and marketed specifically for emergency seizure management. Bausch Health (formerly Valeant) continues to be a dominant supplier of DIASTAT in North America.
2. Sandoz (Novartis Division)
While Sandoz is internationally known for generic formulations, it is not a manufacturer of DIASTAT in the US; however, it produces diazepam in various formulations for other indications and regions. The company's broad portfolio includes rectal gels and injectable forms of diazepam, which can serve as alternative supply sources in some markets.
3. Mylan (now part of Viatris)
Mylan has historically produced generic diazepam preparations, including injectable forms and, in some regions, rectal gels. Although Mylan has not been a primary supplier of DIASTAT specifically, their diazepam products are often considered potential sources for supply chains in regions lacking DIASTAT-specific formulations.
4. Teva Pharmaceutical Industries
Teva manufactures generic diazepam tablets and injectable solutions globally. While they are not traditionally associated with DIASTAT’s rectal gel formulation, they form part of the broader diazepam supply matrix that can influence availability.
Regulatory Approvals and Distribution
The supply of DIASTAT is governed by regulatory approvals, including the FDA's regulatory oversight in the U.S. and equivalent agencies globally such as the European Medicines Agency (EMA). Approved suppliers must meet Good Manufacturing Practices (GMP) standards, which restrict the number of authorized manufacturers and distributors.
In the United States, the primary supplier remains Bausch Health, with the product distributed through an authorized network of pharmacies and specialty clinics. The limited manufacturing approvals contribute to the scarcity and high demand for licensed DIASTAT supplies.
Alternative and Competitor Suppliers
With the expiration of some patents and the emergence of generic formulations, alternative suppliers produce diazepam rectal gels under different brand names or as compounded preparations. Compounded diazepam gels are often used as alternatives when DIASTAT is unavailable, though they may not possess the same regulatory approval status or stability profiles.
Global Market Dynamics
In international markets, generic manufacturers in countries such as India, China, and European nations often produce diazepam formulations, including rectal gels. However, these are typically marketed under different brand names and may not be directly comparable or authorized for emergency seizure use like DIASTAT.
Supply Chain Challenges and Risks
- Limited Number of Manufacturers: The proprietary nature and strict regulatory environment restrict the number of authorized DIASTAT manufacturers, magnifying supply vulnerability.
- Regulatory Hurdles: Changes in approval status, manufacturing issues, or supply chain disruptions can impact availability.
- Market Demand: Growing prevalence of epilepsy and need for emergency seizure management exert upward pressure on supply stability.
- Global shortages: Similar to other controlled substances, diazepam-based formulations sometimes experience shortages due to manufacturing and supply chain issues.
Future Outlook
Increasing international demand and supply chain diversification could influence the availability of DIASTAT. Manufacturers may expand or modify formulations to meet clinical needs, fostering competition. Regulatory agencies are also exploring pathways to streamline approval processes for alternative suppliers and generics, which could broaden supply options.
Key Takeaways
- Primary Supplier: Bausch Health (formerly Valeant Pharmaceuticals) remains the main supplier of DIASTAT in North America.
- Alternate Sources: Generic manufacturers like Mylan (Viatris), Teva, and regional players produce diazepam formulations, including rectal gels, impacting the broader supply landscape.
- Supply Risks: Limited manufacturing approvals and high regulation create supply vulnerabilities, necessitating contingency planning among healthcare providers.
- Global Market Variability: International production varies significantly, with many regions relying on imported or compounded formulations.
- Industry Trends: Ongoing regulatory developments and increased generic competition are likely to influence future supply chain configurations.
FAQs
1. Who are the authorized suppliers of DIASTAT in the United States?
Bausch Health remains the primary FDA-approved manufacturer and supplier of DIASTAT in the U.S., with distribution channels tightly regulated to ensure safety and quality.
2. Can other companies produce DIASTAT besides Bausch Health?
While other companies manufacture diazepam formulations, only a select few have FDA authorization to produce DIASTAT specifically, given its specialized rectal gel formulation and labeling.
3. Are generic alternatives available for DIASTAT?
Generic diazepam rectal gels are available in some markets from manufacturers like Mylan (Viatris) and others, but they may lack formal approval as an equivalent emergency seizure treatment.
4. How do supply chain disruptions affect DIASTAT availability?
Limited authorized manufacturing and stringent regulatory controls make DIASTAT susceptible to shortages, which can impact emergency seizure management treatment plans.
5. What is the future outlook for DIASTAT suppliers?
Increased generic competition and regulatory efforts to streamline manufacturing approvals may diversify the supplier base, improving availability and reducing shortages.
References
[1] U.S. Food and Drug Administration. DIASTAT (diazepam rectal gel) - FDA Approval.
[2] Bausch Health. DIASTAT Product Information.
[3] European Medicines Agency. Guidelines on quality requirements for diazepam formulations.
[4] Mylan. Generic diazepam products.
[5] Teva Pharmaceutical Industries. Diazepam formulations overview.
