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Suppliers and packagers for lovaza
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lovaza
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Waylis Therap | LOVAZA | omega-3-acid ethyl esters | CAPSULE;ORAL | 021654 | NDA | Waylis Therapeutics LLC | 80725-420-12 | 120 CAPSULE in 1 BOTTLE, PLASTIC (80725-420-12) | 2025-01-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers of the Pharmaceutical Drug Lovaza
Who are the primary suppliers of Lovaza?
Lovaza is a prescription omega-3-acid ethyl esters used to lower triglyceride levels. The drug is marketed by GlaxoSmithKline (GSK). Since its approval, key suppliers have included:
- GSK: Original patent holder and manufacturer.
- Teva Pharmaceuticals: Generic versions obtained after patent expiry.
- Mylan (now part of Viatris): Developed generic formulations.
- Amneal Pharmaceuticals: Entered the market with generic versions.
- Lupin Pharmaceuticals: Licensed to market generics in certain regions.
Manufacturing and sourcing details
GSK manufacturing landscape
GSK produces Lovaza at multiple facilities globally, primarily located in the United States, where the drug was initially developed and marketed since 2004. The manufacturing process involves extraction of omega-3 fatty acids from fish oil, followed by refining and encapsulation.
Generic suppliers
Post-patent expiration in 2014, several pharmaceutical companies gained approval for generic omega-3-acid ethyl esters, increasing supply competition. These suppliers source omega-3 fatty acids from fish oils, which are processed under Good Manufacturing Practice (GMP) standards to ensure safety and efficacy.
Supply chain considerations
- Raw materials: Fish oil derived from anchovies, sardines, and menhaden in regional harvesting zones.
- Processing: Refining involves extraction, purification, and concentration steps.
- Quality control: Heavy regulation ensures potency, purity, and stability.
Regional suppliers
Regional suppliers may differ based on regulatory approvals and manufacturing licenses. For example, in India, Lupin is among the prominent licensed producers, sourcing raw fish oils from nearby fisheries.
Market dynamics and implications for supply
- Patent expiry in 2014 opened markets for generic omega-3 formulations.
- Market share: GSK retains significant share in the marketed segment, with generics capturing an increasing portion post-patent loss.
- Supply risks: Fish oil shortages, regulatory shifts, and quality concerns influence manufacturing stability.
- Price trends: Generic competition drives prices down; raw material costs impact profit margins.
Summary table: Key Lovaza suppliers
| Supplier | Region | License/Status | Manufacturing Focus |
|---|---|---|---|
| GlaxoSmithKline (GSK) | Global (Primarily US) | Original patent holder; exclusive rights before 2014 | Brand production |
| Teva Pharmaceuticals | Global | Approved generic in multiple markets | Generic omega-3-acid ethyl esters |
| Mylan (Viatris) | Global | Approved generics | Pharmaceutical-grade fish oil sourcing |
| Amneal Pharmaceuticals | US, Europe | Licensed generic rights in US and some markets | Encapsulated omega-3 formulations |
| Lupin Pharmaceuticals | India, select regions | Licensed producer; regional markets | Fish oil processing and pill formulation |
Key considerations for stakeholders
- Supply chain resilience: Vendors need to ensure stable fish oil sourcing under global fishing and environmental regulations.
- Regulatory compliance: Suppliers must meet GMP standards for production and distribution.
- Cost management: Raw material costs and patent expiries influence pricing strategies.
Key Takeaways
- GSK is the primary original manufacturer of Lovaza.
- Multiple generic suppliers—Teva, Mylan, Amneal, Lupin—produce omega-3-acid ethyl esters post-2014 patent expiration.
- Fish oil sourcing and quality control are critical to maintaining supply stability.
- Generic competition has increased supply and driven prices downward.
- Regional suppliers vary, with licensing agreements influencing market availability.
FAQs
Q1: When did the patent for Lovaza expire?
A1: The patent expired in 2014, enabling the emergence of generic versions.
Q2: Are generic versions of Lovaza structurally identical?
A2: Generic omega-3-acid ethyl esters match the active pharmaceutical ingredient (EPA and DHA content) but may differ in excipients and formulation.
Q3: What regions are most affected by generic Lovaza supplies?
A3: The United States, Europe, and India saw the most significant uptake of generic formulations.
Q4: What raw materials are used in the production of Lovaza?
A4: Fish oils from anchovies, sardines, and menhaden serve as raw materials.
Q5: Are there supply concerns that could affect availability?
A5: Yes, issues like fish stock sustainability, regulatory changes, and manufacturing capacity can influence supply stability.
References
[1] U.S. Food and Drug Administration. (2014). FDA approves first generic versions of Lovaza. https://www.fda.gov/
[2] GlaxoSmithKline. (2022). Lovaza product information. https://www.gsk.com/
[3] IMS Health. (2015). Market analysis of omega-3 fatty acid products.
[4] WHO. (2018). Fish Oil Production and Marine Resources.
[5] Mylan. (2020). Product portfolio.
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