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Suppliers and packagers for DEFINITY RT
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DEFINITY RT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lantheus Medcl | DEFINITY RT | perflutren | INJECTABLE;INTRAVENOUS | 021064 | NDA | Lantheus Medical Imaging, Inc. | 11994-011-01 | 1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS | 2001-07-31 |
| Lantheus Medcl | DEFINITY RT | perflutren | INJECTABLE;INTRAVENOUS | 021064 | NDA | Lantheus Medical Imaging, Inc. | 11994-011-04 | 4 VIAL, GLASS in 1 CARTON (11994-011-04) / 1.5 mL in 1 VIAL, GLASS | 2001-07-31 |
| Lantheus Medcl | DEFINITY RT | perflutren | INJECTABLE;INTRAVENOUS | 021064 | NDA | Lantheus Medical Imaging, Inc. | 11994-011-16 | 16 VIAL, GLASS in 1 CARTON (11994-011-16) / 1.5 mL in 1 VIAL, GLASS | 2001-07-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DEFINITY RT
Introduction
DEFINITY RT, a well-established diagnostic ultrasound contrast agent, is integral for enhancing the visualization of cardiac chambers, vascular structures, and other anatomical features during ultrasound imaging. As a critical product in cardiology and radiology, its supplier landscape significantly impacts healthcare providers’ access, cost structures, and innovation trajectories. This analysis delves into the primary suppliers of DEFINITY RT, evaluates market dynamics, and explores implications for stakeholders.
Overview of DEFINITY RT
DEFINITY RT is a commercially approved ultrasound contrast agent comprising synthetic microbubbles designed for intravenous use. It is primarily utilized in echocardiography and vascular imaging to improve diagnostic accuracy. Developed and marketed by Lantheus Medical Imaging, DEFINITY RT is a medication-intensive product with specific manufacturing and distribution channels governed by strict regulatory standards.
Manufacturers and Supply Chain Overview
1. Lantheus Medical Imaging
Lantheus is the originator and sole manufacturer of DEFINITY RT, holding exclusive rights over its formulation, manufacturing, and distribution. The company operates state-of-the-art facilities adhering to Good Manufacturing Practice (GMP) standards to ensure product consistency and safety. Their manufacturing process involves specialized equipment to produce and package microbubble formulations, with strict control over quality and efficacy parameters.
2. Contract Manufacturing and Licensing
While Lantheus retains primary manufacturing rights, it may leverage third-party manufacturing facilities through licensing agreements. Such arrangements, although not publicly detailed extensively, enhance production capacity or provide regulatory compliance benefits in specific regions.
3. Regional Distributors & Supply Channels
Lantheus maintains a tightly controlled supply chain through regional distributors, hospitals, and healthcare providers. Distribution involves specialized logistics to ensure product integrity, particularly since DEFINITY RT requires refrigerated storage and immediate use following preparation.
Emerging Supply Considerations
a. Supply Chain Disruptions
Global disruptions, such as those caused by the COVID-19 pandemic, have underscored vulnerabilities in the supply of specialized pharmaceuticals like DEFINITY RT. Manufacturing delays, logistical constraints, and regulatory approvals can influence supply stability.
b. Regulatory Approvals and Market Access
Lantheus holds regulatory approvals with agencies like the FDA (United States), EMA (European Union), and other regional authorities, facilitating broad distribution. However, approval processes and subsequent market access can affect supply consistency across geographies.
c. Potential for Biosimilar Entry
Currently, Lantheus retains exclusivity for DEFINITY RT, but the landscape could shift with the advent of biosimilars or generic microbubble contrast agents, pending patent expirations or regulatory pathways. Such entrants could diversify supply sources but require significant investments in manufacturing capabilities and regulatory approval.
Key Suppliers and Competitors
Currently, Lantheus Medical Imaging is the sole supplier of DEFINITY RT. No direct biosimilar or competitive microbubble contrast agents are FDA-approved or widely available in major markets as of 2023. This exclusivity means the supply chain for DEFINITY RT is concentrated and potentially vulnerable to single-source risks.
However, alternative ultrasound contrast agents—such as Lumason (also known as SonoVue outside the United States) and other microbubbles— serve similar functions but are not interchangeable for regulatory or clinical purposes. These alternatives are supplied by different manufacturers and may impact the demand and strategic considerations for DEFINITY RT.
Market Dynamics & Future Outlook
1. Supply Security
Given the proprietary nature of DEFINITY RT, Lantheus’s manufacturing process and regulatory approvals are central to supply stability. The company’s ongoing investments in manufacturing capacity and quality assurance are crucial in mitigating shortages.
2. Competitive Pressures and Innovation
Potential entry of biosimilars or alternative contrast agents could alter the supplier landscape, increase competition, and influence pricing strategies. Such dynamics may also drive Lantheus to innovate or diversify its portfolio.
3. Regional Market Expansion
Expanding into emerging markets with growth in diagnostic imaging could demand increased supply and possibly prompt partnerships with regional manufacturers or distributors.
4. Regulatory Developments
Changes in regulatory policies, including expedited approvals or new safety standards, can influence supply chain operations, especially for novel contrast agents.
Implications for Stakeholders
- Healthcare Providers: Must manage supply risks, especially during periods of manufacturing or logistical disruptions.
- Pharmaceutical Companies: Should monitor regulatory developments and potential entry of biosimilars to anticipate market shifts.
- Investors: Need to evaluate the concentration risk associated with Lantheus’s sole supplier status and assess prospects for diversification.
- Regulatory Agencies: Play a pivotal role in ensuring supply security through streamlined approval processes and monitoring.
Key Takeaways
- Lantheus Medical Imaging is the exclusive manufacturer and supplier of DEFINITY RT globally, leveraging proprietary microbubble technology.
- The supply chain is highly concentrated, subject to risks from manufacturing disruptions, regulatory delays, and regional market access issues.
- No biosimilar competitors currently exist, but potential future entrants could diversify supply sources.
- Ensuring robust manufacturing capacity and regulatory compliance is critical for maintaining supply stability.
- Stakeholders should proactively monitor developments related to regulatory changes, market expansion, and technological innovations that could influence the supply landscape.
FAQs
1. Who are the primary suppliers of DEFINITY RT?
Lantheus Medical Imaging is the sole manufacturer and supplier of DEFINITY RT globally, controlling its production and distribution.
2. Are there any biosimilars or generic alternatives to DEFINITY RT available?
As of 2023, no approved biosimilars or generics for DEFINITY RT are available. The market remains exclusively supplied by Lantheus.
3. What are the main risks to the supply of DEFINITY RT?
Risks include manufacturing delays, regulatory hurdles, logistical disruptions, and potential patent or exclusivity expirations encouraging biosimilar development.
4. How does Lantheus ensure the quality and safety of DEFINITY RT?
Lantheus adheres to GMP standards, employs rigorous quality control in manufacturing, and secures regulatory approvals to maintain product safety and efficacy.
5. What future developments could impact the supply of DEFINITY RT?
The entry of biosimilars, regulatory policy changes, expansions into new markets, and technological innovations in contrast agents could all influence supply dynamics.
References
- Lantheus Medical Imaging. (2022). DEFINITY [Product Information].
- U.S. Food and Drug Administration. (2020). Approved Drug Products: DEFINITY.
- European Medicines Agency. (2019). Marketing authorization for Lumason outside the US.
- Market research reports on contrast agent manufacturing and supply chain risks.
- Industry news articles on biosimilar development in ultrasound contrast agents.
Note: This analysis is based on publicly available information as of 2023 and is intended for informational purposes only. Supply conditions and market dynamics are subject to change.
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