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Suppliers and packagers for DEPAKOTE ER
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DEPAKOTE ER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168 | NDA | AbbVie Inc. | 0074-7401-13 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7401-13) | 2000-08-04 |
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168 | NDA | AbbVie Inc. | 0074-7402-13 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7402-13) | 2000-08-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DEPAKOTE ER
Introduction
Depakote ER (Extended Release), known generically as divalproex sodium, is a widely prescribed anticonvulsant and mood stabilizer used primarily in the management of epilepsy, bipolar disorder, and migraine prophylaxis. The pharmaceutical supply chain for Depakote ER involves a complex network of manufacturers, authorized suppliers, and generic producers, each playing a vital role in ensuring patient access to this essential medication. This article provides a comprehensive overview of the key suppliers, highlighting manufacturing dynamics, market players, and regulatory considerations critical to business professionals analyzing the Depakote ER supply landscape.
Manufacturers of Branded Depakote ER
AbbVie Inc.: Historically, AbbVie acquired the rights to Depakote ER from Abbott Laboratories following Abbott’s spin-off of its pharmaceutical division in 2013. As the main patent holder and original manufacturer, Abbott (now part of AbbVie) remains a primary source of the branded product in various markets. The company's manufacturing facilities in the United States and Europe produce Depakote ER under strict compliance with regulatory standards set by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Market Exclusivity and Patent Status: While the primary patent for Depakote ER has expired or is nearing expiration in many jurisdictions, Abbott/AbbVie maintains relevant extensions and exclusivities in specific markets. As a result, patent protections influence the supply dynamics, especially in regions where branded products are dominant.
Generic Manufacturers and Suppliers
Following patent expiration in many markets, generic manufacturers rapidly entered the landscape, significantly broadening the supply base and reducing costs. Key generic producers include:
1. Mylan (now part of Viatris)
One of the largest generic producers globally, Mylan has longstanding manufacturing capabilities for divalproex sodium ER formulations. Their facilities in Europe and North America produce both branded and generic versions, backed by extensive regulatory approvals such as ANDA (Abbreviated New Drug Application) filings with the FDA.
2. Teva Pharmaceuticals
Teva, an Israeli-based pharmaceutical giant, is a leading supplier of generic anticonvulsants, including divalproex sodium ER. Their global manufacturing footprint includes facilities compliant with cGMP standards, ensuring consistent product quality.
3. Sandoz (a Novartis division)
Sandoz operates several manufacturing sites dedicated to generics and biosimilars. Their divalproex sodium ER offerings are widely available in North America and Europe, with regulatory approval for multiple formulations.
4. Cipla Ltd.
An India-based manufacturer with a significant footprint in emerging markets, Cipla supplies generic divalproex sodium ER, often at lower price points, expanding access in Asia, Africa, and other developing regions.
5. Lupin Limited
Lupin, another Indian pharmaceutical firm, produces generic anticonvulsants, including divalproex sodium ER, with approvals in various international markets, including the FDA and EMA.
6. Aurobindo Pharma
Specializing in generics, Aurobindo manufactures divalproex sodium ER formulations approved for multiple markets, leveraging its integrated supply chain.
Authorized Distributors and Wholesalers
Once manufactured, Depakote ER and its generics reach healthcare providers through a network of authorized distributors, including:
- McKesson Corporation
- AmerisourceBergen Corporation
- Cardinal Health
These distributors ensure efficient distribution channels in North America, maintaining stock levels and compliance with regulatory standards.
Internationally, regional distributors and wholesalers facilitate access in developing markets, often sourcing from the generic manufacturers listed above. Due diligence in verifying authenticity and regulatory compliance remains critical due to the prevalence of counterfeit and substandard products in certain regions.
Regulatory and Supply Chain Challenges
Regulatory approvals influence supplier viability and continuity. Approval processes, such as FDA's ANDA pathway for generics or New Drug Applications (NDA) for branded formulations, determine market access and supply stability. Patent rights, exclusivities, and legal Hatch-Waxman protections shape competition.
Supply chain disruptions, as experienced during the COVID-19 pandemic, have highlighted vulnerabilities in manufacturing capacities, especially among Indian generics producers. Raw material shortages and regulatory bottlenecks can cause fluctuations in availability and pricing.
Emerging Trends and Future Outlook
1. Biosimilars and Innovative Alternatives
While biosimilars are inherently biological products, the trend toward developing novel formulations aims to improve bioavailability or reduce side effects, potentially impacting traditional suppliers.
2. Regional Manufacturing Expansion
Manufacturers like Aurobindo and Lupin are expanding their production capacities in India and Southeast Asia, aiming to meet growing demand while mitigating geopolitical risks.
3. Contract Manufacturing and Partnerships
Strategic alliances between pharmaceutical companies and contract manufacturing organizations (CMOs) enable scalable production, cost optimization, and regulatory agility.
4. Digital Supply Chain Integration
Implementing real-time tracking and blockchain technology enhances transparency and combats counterfeiting, ensuring that genuine Depakote ER reaches patients worldwide.
Conclusion
The Depakote ER supply chain is characterized by a diversified set of primary manufacturers ranging from original patent holders (AbbVie) to a broad spectrum of generic producers, notably in India and Europe. Market dynamics are largely driven by patent statuses, regional regulatory landscapes, and manufacturing capacities. Business professionals must monitor these factors, alongside geopolitical and logistical developments, to accurately assess supply stability and procurement strategies.
Key Takeaways
- Dominant Suppliers: The original manufacturer is Abbott/AbbVie, with numerous generic players including Mylan, Teva, Sandoz, Cipla, Lupin, and Aurobindo providing cost-effective alternatives globally.
- Market Impact of Patent Laws: Expirations and patent protections significantly influence supplier diversity, costs, and availability.
- Supply Chain Risks: Manufacturing disruptions, regulatory delays, and geopolitical factors require ongoing risk management for consistent supply.
- Regional Variability: Emerging markets depend heavily on Indian and Asian generics, emphasizing the importance of verifying authenticity and regulatory compliance.
- Future Trends: Expansion of manufacturing capacity, digital supply chain innovations, and potential formulation improvements will shape the competitive environment for Depakote ER.
FAQs
1. Who are the main suppliers of branded Depakote ER?
AbbVie, through its predecessor Abbott, remains the principal branded supplier in many markets, holding the original patent rights and manufacturing facilities globally.
2. Which companies produce generic divalproex sodium ER?
Major generic producers include Mylan/Viatris, Teva Pharmaceuticals, Sandoz, Cipla, Lupin, and Aurobindo, among others.
3. How do patent expirations affect the drug supply?
Patent expirations open the market to generic competitors, usually resulting in increased supply, price reductions, and broader regional availability.
4. What regulatory challenges influence the Depakote ER supply chain?
Regulatory approvals such as FDA’s ANDA process and EMA’s marketing authorizations establish compliance and influence the stabilization of global supply.
5. Are there concerns about counterfeit or substandard products?
Yes, especially in emerging markets. Ensuring authenticity involves sourcing from authorized distributors and verifying regulatory approvals.
References
- FDA. (2022). Abbreviated New Drug Applications (ANDAs).
- AbbVie. Product Portfolio and Patent Information.
- Viatris. Corporate Overview.
- Teva Pharmaceuticals. Global Product Portfolio.
- Indian Pharmaceutical Industry Reports. Market Dynamics and Production Capacity Data.
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