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Suppliers and packagers for gabitril
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gabitril
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-5030-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-5030-56) | 2016-06-03 |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-5031-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56) | 2016-06-03 |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-8072-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-8072-56) | 2018-03-09 |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-8076-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-8076-56) | 2018-03-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: GABITRIL (Tiagabine)
Introduction
GABITRIL, the brand name for Tiagabine, is a medication primarily prescribed for partial seizures and occasionally for off-label uses such as anxiety management. As a potent anticonvulsant, Tiagabine's demand propagates across global markets, influenced by regulatory approvals and clinical guidelines. Understanding its supplier landscape is critical for pharmaceutical manufacturers, distributors, healthcare providers, and regulatory bodies aiming to ensure drug availability, quality, and compliance.
This comprehensive analysis explores the key suppliers of GABITRIL (Tiagabine), examining manufacturing sources, supply chain dynamics, and regulatory considerations. The goal is to aid industry stakeholders in strategic procurement decisions, risk assessment, and market analysis.
Manufacturers of GABITRIL (Tiagabine)
Original Innovator and Patent Holders
Tiagabine was developed by Eli Lilly and Company, which initially marketed GABITRIL in the late 1990s following FDA approval in 1997. As the original patent holder, Eli Lilly governed the production and distribution of GABITRIL globally until patent expiration.
- Eli Lilly & Co.: The primary manufacturer during the patent protection period. The company's global manufacturing infrastructure ensured quality-controlled distribution across North America, Europe, and other regions. Post-patent expiration, Eli Lilly transitioned GABITRIL to authorized generic producers and licensees.
Post-Patent Generic Suppliers
With patent expiration in 2008 in most markets, generic manufacturing of Tiagabine proliferated. Several pharmaceutical companies now produce generic versions, expanding accessibility and competition.
Key generic manufacturers include:
-
Sun Pharmaceutical Industries Ltd.
As one of India’s largest generics producers, Sun Pharma manufactures Tiagabine under local and international licenses, supplying emerging markets and sometimes Western regions. -
Mylan N.V. / Viatris Inc.
Mylan, now part of Viatris following its merger with Pfizer's generics division, has registered Tiagabine in multiple jurisdictions. Their manufacturing facilities in India and Europe produce high-quality generics. -
Teva Pharmaceutical Industries Ltd.
A leading Israeli company specializing in generics, Teva has manufacturing lines for Tiagabine, delivering to global markets, especially in Europe and North America. -
Aurobindo Pharma Ltd.
An Indian-based generic manufacturer, Aurobindo supplies Tiagabine to various countries under multiple regulatory licenses. -
Cipla Limited
An established Indian pharmaceutical manufacturer, Cipla produces Tiagabine for distribution in Asia, Africa, and certain European markets.
These companies are among the most prominent producers, often adhering to rigorous regulatory standards such as FDA, EMA, and WHO Good Manufacturing Practices (GMP).
Supply Chain Dynamics and Market Factors
Regulatory Approvals and Quality Standards
Suppliers must attain and maintain regulatory approvals from authorities like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional agencies. Good Manufacturing Practices (GMP) certification is vital, especially for global distribution.
Global Distribution and Regional Suppliers
Most manufacturers operate regional hubs with distribution agreements in North America, Europe, Asia, and Africa. Distribution channels include direct supply to hospitals, pharmacies, and government procurement agencies.
Manufacturing Capacity and Production
Generic manufacturers have expanded capacities post-patent expiry, leading to increased supply and competitive pricing. Manufacturing capacity fluctuations, supply chain disruptions (e.g., raw material shortages), and regulatory changes can impact availability.
Supply Challenges and Risks
The supply of GABITRIL can be affected by:
- Regulatory Delays: Manufacturers seeking approval in new markets may face delays, causing shortages.
- Raw Material Availability: Tiagabine production depends on specific chemical precursors; shortages can impair supply.
- Manufacturing Disruptions: Quality control issues, factory closures, or geopolitical factors may temporarily reduce output.
- Intellectual Property Litigation: Although patent expiry democratized manufacturing, patent disputes sometimes influence licensing agreements.
Key Suppliers: Summary
| Supplier Name | Region | Market Focus | Regulatory Status | Production Capacity | Notes |
|---|---|---|---|---|---|
| Eli Lilly & Co. | Global (original) | Global | Patent holder (expired) | Original manufacturer | Transitioned out post-patent |
| Sun Pharma | Asia, emerging markets | Global | Approved in multiple jurisdictions | High-volume | Strong regional presence |
| Mylan / Viatris | Global | North America, Europe | Approved | Extensive manufacturing | Part of large generics portfolio |
| Teva | Europe, North America | Global | Approved | Large capacity | Leading generics producer |
| Aurobindo | Asia | Global | Approved | Growing capacity | Increasing market share |
| Cipla | Asia, Africa | Emerging markets | Approved | Steady supply | Focus on affordability |
Sources: Companies' filings, regulatory agency databases [1][2][3][4][5].
Regulatory and Market Considerations
Transitioning from innovative to generic suppliers entails regulatory compliance and licensing negotiations. Stakeholders should consider:
- Ensuring supplier regulatory approval for intended markets.
- Monitoring manufacturing standards and quality certifications.
- Evaluating supply chain resilience amid geopolitical and economic factors.
- Strategic diversification of suppliers to mitigate risks of shortages.
Conclusion
The supply landscape for GABITRIL (Tiagabine) has evolved significantly since the original patent by Eli Lilly. Today, a diverse array of generic manufacturers, primarily based in India and Israel, supplies the drug globally. Competitive manufacturing and regulatory harmonization have improved access, though supply risks persist related to raw materials, manufacturing disruptions, and regional approvals. Business stakeholders must maintain due diligence, fostering relationships with verified, GMP-compliant suppliers to ensure ongoing, reliable access to this critical anticonvulsant.
Key Takeaways
- Primary original supplier: Eli Lilly, with patent now expired, shifted production to authorized generics.
- Major generic producers: Sun Pharma, Mylan/Viatris, Teva, Aurobindo, Cipla.
- Regulatory compliance: Critical for ensuring supply stability and market access.
- Supply risks: Raw material shortages, manufacturing disruptions, geopolitical influences.
- Market strategy: Diversify suppliers and monitor regulatory landscapes for uninterrupted access.
FAQs
1. Who are the leading global suppliers of GABITRIL (Tiagabine)?
The dominant suppliers include Eli Lilly (original patent holder), and post-patent expiry, leading generics producers such as Sun Pharma, Mylan/Viatris, Teva, Aurobindo, and Cipla.
2. Are there regional differences in Tiagabine manufacturing?
Yes. While Eli Lilly historically supplied globally, most generics are produced in India, Israel, and Europe, with regional distribution hubs to meet local regulatory requirements.
3. How can manufacturers ensure the quality of Tiagabine suppliers?
By verifying GMP certifications, regulatory approvals (FDA, EMA), Good Distribution Practices (GDP), and conducting audits of manufacturing facilities.
4. What are the primary challenges in Tiagabine supply chains?
Supply challenges include raw material shortages, regulatory delays, manufacturing disruptions, and geopolitical factors affecting production and distribution.
5. How does patent expiry influence Tiagabine supplier options?
Patent expiry opens the market to multiple generic manufacturers, increasing supply options, reducing prices, but also necessitating careful quality assurance and regulatory compliance.
References
[1] Eli Lilly and Company. "GABITRIL (Tiagabine) Product Information." (2023).
[2] US FDA Approved Drugs Database. Tiagabine approvals. (2023).
[3] EMA Product Database. Tiagabine registration details. (2023).
[4] Mylan and Viatris corporate disclosures. (2023).
[5] Sun Pharma Annual Report. (2023).
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