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Suppliers and packagers for OLINVYK
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OLINVYK
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Trevena | OLINVYK | oliceridine | SOLUTION;INTRAVENOUS | 210730 | NDA | Trevena, Inc. | 71308-011-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71308-011-10) / 1 mL in 1 VIAL, SINGLE-DOSE (71308-011-01) | 2020-08-07 |
| Trevena | OLINVYK | oliceridine | SOLUTION;INTRAVENOUS | 210730 | NDA | Trevena, Inc. | 71308-021-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71308-021-10) / 2 mL in 1 VIAL, SINGLE-DOSE (71308-021-01) | 2020-08-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: OLINVYK
Introduction
OLINVYK (oliceridine) is a novel opioid indicated for inpatient management of acute pain severe enough to require an intravenous opioid analgesic and where alternative treatments are inadequate. Since its FDA approval in August 2020 by the U.S. Food and Drug Administration, OLINVYK has been positioned as an innovative option within the opioid analgesic market [1]. Its unique mechanism as a G protein-biased μ-opioid receptor agonist distinguishes it from traditional opioids, potentially offering pain relief with a reduced risk of common side effects such as respiratory depression and nausea. However, the success of OLINVYK in clinical practice depends heavily on the robustness of its supply chain and the availability of reliable suppliers.
This report investigates the current landscape of suppliers responsible for the manufacturing, distribution, and supply of OLINVYK, emphasizing the key industry players, manufacturing considerations, and supply chain dynamics.
Manufacturing and Primary Suppliers
Eli Lilly and Company
The primary manufacturer and supplier of OLINVYK is Eli Lilly and Company, a global pharmaceutical giant with extensive experience in producing opioid medications. Lilly's involvement in the development and commercialization of OLINVYK underscores its capacity to meet the high demand for intravenous opioids in hospital settings [2].
Eli Lilly leveraged advanced biotechnological processes and stringent quality control systems to ensure the consistent production of OLINVYK, conforming to U.S. Pharmacopeia standards. Their vertical integration across R&D, manufacturing, and distribution enables a resilient supply chain, although global supply complexities remain inherent, especially in the context of regulatory compliance and raw material procurement.
Manufacturing Facilities
Lilly has dedicated manufacturing facilities for the synthesis, formulation, and injectable production of OLINVYK. These facilities are compliant with Good Manufacturing Practices (GMP) and are subject to ongoing inspections by the FDA and international regulatory bodies to ensure product safety, efficacy, and consistency [3].
The production process involves complex peptide synthesis and rigorous purification steps to ensure bioavailability and stability of the intravenous formulation. Lilly continuously invests in scaling up production capacity to address potential surges in demand, especially considering the ongoing need for effective pain management solutions during the COVID-19 pandemic.
Distribution Channels
While Eli Lilly handles the manufacturing, distribution of OLINVYK involves a range of specialized pharmaceutical distributors and hospital supply chains. Major distributors such as McKesson, Cardinal Health, and AmerisourceBergen are tasked with the logistics, warehousing, and delivery of OLINVYK to healthcare facilities across the United States.
These distribution partners hold strategic inventories and possess extensive networks within the hospital and healthcare provider markets, ensuring rapid and reliable supply. Their capability to adapt to supply chain disruptions—such as those observed during the recent global health crises—is crucial for maintaining consistent availability.
Regulatory and Market Dynamics
The approval and commercialization of OLINVYK were facilitated by Eli Lilly’s compliance with regulatory standards. The drug's class as a Schedule II controlled substance imposes restrictions on manufacturing, distribution, and prescribing processes. Suppliers must maintain rigorous monitoring and reporting systems to adhere to DEA regulations [4].
Market acceptance also influences supply levels. Adoption rates by hospital systems, driven by clinical guidelines and physician prescribing behavior, directly impact demand and supply logistics. The ongoing evaluation of OLINVYK's clinical efficacy and safety profile by healthcare authorities influences supplier order volumes and inventory management.
Alternate and Contract Manufacturers
In addition to Eli Lilly's primary facilities, contract manufacturing organizations (CMOs) may play a role in scaling up production for OLINVYK, especially in response to increased demand or supply disruptions. These third-party manufacturers offer specialized expertise in peptide synthesis and injectable formulations, allowing Lilly to augment its manufacturing capacity without significant capital investment.
However, reliance on CMOs raises questions related to quality assurance, regulatory compliance, and intellectual property, which companies must address through stringent oversight and contractual safeguards [5].
Global Suppliers and Raw Materials
The production of OLINVYK depends on high-quality raw materials, including peptide building blocks and reagents sourced from specialized chemical suppliers worldwide. Suppliers from Europe, Asia, and North America are integral in providing raw materials compliant with pharmaceutical standards.
Global supply chain disruptions—such as those seen during the COVID-19 pandemic—can influence the availability of raw materials, potentially impacting manufacturing timelines. Eli Lilly and other manufacturers mitigate these risks through diversified sourcing strategies and inventory buffers.
Supply Chain Challenges and Future Outlook
Despite current supplier structures, the pharmaceutical supply chain faces challenges including pandemic-related disruptions, raw material shortages, regulatory hurdles, and geopolitical tensions. These factors can constrain OLINVYK production and distribution, emphasizing the importance of multi-channel supplier relationships and contingency planning.
Eli Lilly is exploring partnerships with additional contract manufacturers to enhance supply flexibility. Moreover, continued investment in vertical integration, process innovations, and supply chain resilience remains critical to ensuring stable availability of OLINVYK, particularly as demand fluctuates with evolving clinical guidelines and prescribing practices.
Key Takeaways
- Primary Manufacturer: Eli Lilly and Company leads in the production and supply of OLINVYK, leveraging advanced GMP-compliant manufacturing facilities.
- Distribution Network: Reliance on major pharmaceutical distributors ensures hospital and healthcare provider access across the U.S.
- Regulatory Considerations: Strict compliance with FDA and DEA regulations governs manufacturing and distribution, affecting supply chain operations.
- Supply Chain Risks: Raw material sourcing, global disruptions, and reliance on CMOs pose challenges; diversification strategies are underway.
- Future Supply Resilience: Lilly’s ongoing investments in manufacturing capacity and potential expansion of contract manufacturing aim to meet rising demand.
Frequently Asked Questions
Q1: Who are the main suppliers responsible for manufacturing OLINVYK?
A1: Eli Lilly and Company is the primary manufacturer of OLINVYK, operating GMP-compliant facilities dedicated to its production.
Q2: How is OLINVYK distributed to healthcare providers?
A2: Distribution is managed via major pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen, who supply hospitals and clinics nationwide.
Q3: Are there alternative manufacturing options for OLINVYK?
A3: While Lilly is the primary producer, contract manufacturing organizations (CMOs) may assist in scaling production and mitigating supply risks.
Q4: What raw material sources are involved in OLINVYK production?
A4: Raw ingredients are sourced globally from specialized chemical suppliers in Europe, Asia, and North America, ensuring high purity and quality standards.
Q5: What challenges could impact the future supply of OLINVYK?
A5: Challenges include raw material shortages, global supply chain disruptions, regulatory constraints, and geopolitical tensions. Lilly is working to address these through diversification and capacity expansion.
References
- U.S. Food and Drug Administration. (2020). FDA approves Eli Lilly's OLINVYK for inpatient pain.
- Eli Lilly and Company. (2020). Press Release: Lilly launches OLINVYK, a new IV opioid for pain management.
- U.S. FDA. (2021). Good Manufacturing Practice (GMP) regulations and inspections.
- Drug Enforcement Administration. (2021). Controlled Substances Act regulations.
- MarketWatch. (2022). Contract manufacturing trends in the pharmaceutical industry.
In conclusion, Eli Lilly dominates in the supply of OLINVYK, supported by extensive manufacturing facilities, a broad distribution network, and strategic raw material sourcing. While supply chain risks exist, ongoing capacity development and diversified sourcing strategies are set to bolster supply resilience, ensuring this innovative opioid remains available to meet clinical needs effectively.
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