Suppliers and packagers for oraverse

oraverse

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159	NDA	Septodont, Inc.	0362-0101-10	10 CARTRIDGE in 1 CARTON (0362-0101-10) / 1.7 mL in 1 CARTRIDGE	2011-06-01

Suppliers for the Pharmaceutical Drug: ORAVERSE

Last updated: July 30, 2025

Introduction

Oraverse, known generically asphentolamine mesylate, is a medication primarily used in dentistry to reverse soft tissue anesthesia following dental procedures. Its significance lies in minimizing patient discomfort caused by prolonged numbness after local anesthetic administration. As demand for Oraverse grows in dental practice, understanding its supply chain landscape becomes critical for stakeholders including distributors, dental clinics, and healthcare providers. This report comprehensively examines the primary suppliers for Oraverse, analyzing manufacturing origins, distribution channels, regulatory considerations, and market dynamics influencing supply stability.

Manufacturers and Origin of Oraverse

The origin of Oraverse can be traced to its manufacturer, Dentsply Sirona, a leading global dental products company headquartered in the United States. Dentsply Sirona holds the patent for Oraverse and is the sole authorized producer globally. The formulation comprises phentolamine mesylate, a well-established pharmacologic agent used as a reversible alpha-adrenergic blocker.

Manufacturing and Supply Chain

Dentsply Sirona operates manufacturing facilities in multiple countries, primarily in the United States and Europe, ensuring quality control and regulatory compliance with agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Their integrated production process covers raw material procurement, synthesis, formulation, and packaging.

While Dentsply Sirona maintains exclusive rights to produce Oraverse, the company partners with authorized logistics providers for distribution to global markets. The strategic importance of maintaining a secure and compliant supply chain has led the company to establish regional distribution centers, facilitating rapid delivery and inventory management.

Authorized Distributors and Supply Channels

1. Dentsply Sirona Direct Distribution

Dentsply Sirona directly supplies Oraverse to authorized distributors, dental product resellers, and healthcare institutions worldwide. The company's extensive distribution network ensures timely access to the drug across North America, Europe, Asia-Pacific, and other regions. The direct distribution model helps maintain product integrity, adherence to regulatory standards, and secure supply.

2. Regional Distributors and Market Access

In markets where Dentsply Sirona does not operate directly, local authorized distributors play a pivotal role:

• North America: Regional dental supply distributors such as Henry Schein and Patterson Dental import Oraverse directly from Dentsply Sirona's regional warehouses.

• Europe: Distributors like Henry Schein Europe and Dental Depot receive products through regional channels, ensuring compliance with CE marking and local regulatory approvals.

• Asia-Pacific: Companies like DentalXpress and local authorized importers handle distribution, with regulatory clearance tailored to each country.

These distributors serve as intermediaries, maintaining inventory, providing customer support, and ensuring adherence to local regulations.

3. Online and E-commerce Platforms

While official channels remain primary, some authorized distributors and dental supply e-commerce portals offer Oraverse online. These platforms facilitate bulk purchases by dental clinics, though strict verification ensures product authenticity.

Regulatory Considerations

Oraverse’s distribution is tightly regulated due to its pharmaceutical nature. Dentsply Sirona ensures all shipments comply with Good Manufacturing Practices (GMP), national drug regulations, and import-export controls. In many jurisdictions, the drug is classified as a prescription-only medication, necessitating secure handling and proper documentation during transportation.

Market Dynamics and Supply Challenges

The single-source manufacturing model presents inherent risks. Any disruption—be it regulatory, manufacturing, or geopolitical—can delay supply. Recent global supply chain disruptions, such as those caused by the COVID-19 pandemic, have highlighted vulnerabilities in medical product distribution. Dentsply Sirona has responded by increasing inventory buffers and diversifying regional distribution centers.

Market growth is also influenced by the increasing adoption of dental anesthesia reversal agents. As dental practices seek to enhance patient comfort, the demand for Oraverse is anticipated to rise, potentially straining existing supply channels if production does not scale correspondingly.

Emerging Supply Alternatives and Competition

Currently, Oraverse remains the only approved agent for soft tissue anesthesia reversal, with no direct generic equivalents available commercially. However, ongoing research into alternative agents and formulations could disrupt this landscape in the future, emphasizing the importance of vigilant market monitoring.

Summary

• Manufacture: Dentsply Sirona holds exclusive rights, manufacturing primarily in the U.S. and Europe.
• Distribution: Managed through a combination of direct company channels and authorized regional distributors.
• Supply Chain: Emphasizes quality control, regulatory compliance, and regional logistics.
• Risks: Potential supply disruptions due to manufacturing issues, regulations, or geopolitical factors.
• Market Outlook: Growing demand driven by clinical adoption; supply chain resilience essential.

Key Takeaways

• Dentsply Sirona remains the sole producer of Oraverse, with a tightly controlled global supply chain.
• Authorized distributors, regional and global, serve as critical links facilitating market access.
• Regulatory compliance and quality assurance are paramount in distribution.
• The supply chain faces vulnerabilities from global disruptions; strategic inventory management mitigates risks.
• The expanding dental market underscores the importance of supply chain agility to meet rising demand.

FAQs

1. Who is the main manufacturer of Oraverse?
Dentsply Sirona is the exclusive manufacturer and patent holder of Oraverse globally.

2. How is Oraverse distributed worldwide?
Through a network of authorized regional distributors and direct supply from Dentsply Sirona, ensuring regulatory compliance and product integrity.

3. Are there any generic equivalents to Oraverse?
Currently, no generic versions exist. Dentsply Sirona retains exclusive rights, making supply dependent on their manufacturing capacity.

4. What are the major challenges in the supply chain for Oraverse?
Disruptions can arise from manufacturing delays, regulatory changes, geopolitical events, and global supply chain interruptions like pandemics.

5. How can dental practices ensure reliable access to Oraverse?
By establishing relationships with authorized distributors, maintaining adequate inventory, and considering supply forecasts aligned with clinical demand.

References

[1] Dentsply Sirona Official Website. (2023). Oraverse Product Information.
[2] U.S. Food and Drug Administration. (2023). Drug Approvals and Manufacturers.
[3] European Medicines Agency. (2023). Regulatory Status of Pharmacological Agents.
[4] MarketWatch. (2023). Dental Market Growth and Trends.
[5] International Pharmaceutical Regulators Forum. (2022). Good Manufacturing Practices (GMP) Standards.