Suppliers and packagers for VIVELLE-DOT

VIVELLE-DOT

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7129-83	8 POUCH in 1 CARTON (0781-7129-83) / 1 PATCH in 1 POUCH (0781-7129-58) / 3.5 d in 1 PATCH	2014-12-22
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7138-83	8 POUCH in 1 CARTON (0781-7138-83) / 1 PATCH in 1 POUCH (0781-7138-58) / 3.5 d in 1 PATCH	2014-12-22
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7144-83	8 POUCH in 1 CARTON (0781-7144-83) / 1 PATCH in 1 POUCH (0781-7144-58) / 3.5 d in 1 PATCH	2014-12-22

Suppliers for the Pharmaceutical Drug: Vivelle-Dot

Last updated: July 29, 2025

Introduction

Vivelle-Dot, a transdermal estrogen replacement therapy, primarily contains estradiol and is prescribed to treat menopause symptoms, osteoporosis prevention, and hormone replacement therapy (HRT) for women with estrogen deficiency. As a prescribed medication, the supply chain for Vivelle-Dot involves various pharmaceutical manufacturers, distributors, and wholesale suppliers specialized in hormone therapies and transdermal drug delivery systems. Understanding the landscape of equipment, raw materials, and commercial suppliers is essential for stakeholders aiming to ensure reliable access, optimize inventory, or explore manufacturing opportunities.

Manufacturing and Brand Ownership

Vivelle-Dot is marketed under the Hormone Replacement Therapy (HRT) category, with responsibilities divided among pharmaceutical giants such as AbbVie and other key players in the hormone therapy segment. Traditionally, the drug has been marketed by AbbVie, a leading global biopharmaceutical company specializing in innovative therapies.

AbbVie's Role as the Primary Manufacturer

AbbVie's Mylan brand historically produced Vivelle-Dot under licensing agreements, but the manufacturing rights are largely held by AbbVie, which formulates, tests, and distributes the product globally. The consistent supply of Vivelle-Dot depends on AbbVie's manufacturing facilities, which are equipped with advanced pharmaceutical production lines tailored for transdermal patches.

Licensing and Partnerships

In some regions, licensing agreements allow local pharmaceutical companies to manufacture generic versions or alternative formulations of estradiol patches that mimic Vivelle-Dot's therapeutic profile. These partnerships affect supply stability and competitive dynamics in the market.

Raw Material Suppliers

The core raw material for Vivelle-Dot is estradiol, a non-steroidal estrogen hormone synthesized via chemical processes or extracted from natural sources. The supply of estradiol hinges on high-purity chemical suppliers that meet regulatory standards (e.g., FDA, EMA) for pharmaceutical manufacturing.

Key Raw Material Suppliers

1. Chiral Chemical Suppliers
   • Companies like BASF and Merck KGaA supply chiral precursors and intermediates essential for synthesizing estradiol.
2. Active Pharmaceutical Ingredient (API) Manufacturers
   • Mitsubishi Tanabe Pharma Corporation and IBSA are prominent suppliers involved in manufacturing estradiol APIs conforming to Good Manufacturing Practice (GMP) standards.
3. Excipient Suppliers
   • The adhesive components, polymers, and other excipients in Vivelle-Dot are supplied by firms such as Lubrizol, Dow Corning, and 3M.

Regulatory and Quality Standards

Suppliers of estradiol and excipients must comply with stringent regulatory standards, including FDA's Current Good Manufacturing Practice (cGMP) and EMA guidelines, to ensure purity, stability, and batch-to-batch consistency.

Manufacturing of Transdermal Patches

Vivelle-Dot's unique delivery system depends on specialized manufacturing equipment, including:

• Layer Coating Systems for precise application of drug formulations onto patches.
• Lamination Lines for integrating various layers to create a stable, flexible patch.
• Quality Control Instruments for in-process testing and final product validation.

Major contract manufacturing organizations (CMOs) specializing in transdermal patches, such as Catalent and Qualicaps, may be engaged for production or packaging, depending on regional regulations and capacity needs.

Distribution and Wholesale Supply

Distribution channels for Vivelle-Dot involve multiple tiers:

• Pharmaceutical Distributors like McKesson, AmerisourceBergen, and Cardinal Health handle bulk distribution to pharmacies, hospitals, and clinics.
• Specialized Hormone Therapy Suppliers focus on endocrinology clinics and specialty pharmacies, ensuring targeted delivery.

Contrary to the raw material supply chain, distribution is largely determined by market demand, regulatory compliance, and regional supply chain infrastructure.

Global Market and Key Suppliers

While AbbVie's manufacturing facilities serve as central hubs, the global landscape features several key suppliers acting as secondary or tertiary providers:

• GSK and Pfizer produce market competitors and alternative estrogen therapies.
• Teva Pharmaceutical Industries supplies generics, impacting the overall availability and pricing landscape.
• Sandoz, a Novartis division, provides generic estrogen patches, offering alternatives to branded Vivelle-Dot.

The supply chain’s robustness depends on geopolitical stability, raw material availability, and regulatory environment adherence across regions.

Challenges and Opportunities

Supply chain vulnerabilities — such as raw material shortages (notably estradiol), manufacturing disruptions, or regulatory hurdles — can impact the availability of Vivelle-Dot. Conversely, emerging players and biosimilar developers seek to expand supply options, potentially reducing costs and increasing market access.

Advancements in biotechnological synthesis and regulatory streamlining present opportunities for both established manufacturers and new entrants to strengthen supply chains, diversify sourcing, and optimize costs.

Conclusion

The supply chain of Vivelle-Dot comprises multiple interconnected tiers — from raw material suppliers producing high-grade estradiol and excipients to manufacturing facilities specializing in transdermal patches, to extensive distribution networks. Dominated primarily by AbbVie, the ecosystem involves various strategic partnerships and global suppliers committed to compliance with regulatory standards.

Ensuring a reliable supply of Vivelle-Dot requires continuous monitoring of raw material markets, manufacturing capacities, and geopolitical factors influencing key suppliers. Stakeholders must consider these dynamics to mitigate risks, optimize procurement strategies, and secure consistent patient access to this essential hormone therapy.

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Key Takeaways

• AbbVie is the primary manufacturer and market leader for Vivelle-Dot, with global supply chains supported by licensed manufacturers.
• Estradiol raw materials are sourced from specialized chemical suppliers like BASF, Merck, and Mitsubishi Tanabe, all adhering to strict GMP standards.
• Excipients and adhesives are supplied by companies like Lubrizol and 3M, critical for the patch's therapeutic performance.
• Manufacturing involves advanced coating and lamination technologies, often outsourced to specialized CMOs.
• Distribution channels encompass major pharmaceutical wholesalers and specialty pharmacies, ensuring broad patient access.

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FAQs

1. What are the primary raw materials used in Vivelle-Dot production?
   The main raw materials are high-purity estradiol hormone and specific excipients (adhesives, polymers) sourced from certified chemical suppliers.

2. Which companies manufacture the estradiol active pharmaceutical ingredient (API) for Vivelle-Dot?
   Leading API manufacturers include Mitsubishi Tanabe Pharma Corporation and IBSA, among others, all certified under GMP standards.

3. How does supply chain disruption affect Vivelle-Dot availability?
   Disruptions in raw material supply, manufacturing delays, or geopolitical conflicts can lead to shortages, affecting patient access and prescribing practices.

4. Are there generic alternatives to Vivelle-Dot?
   Yes, several generic estradiol transdermal patches are available, produced by companies like Teva and Sandoz, increasing competition and supply options.

5. What role do contract manufacturing organizations (CMOs) play in Vivelle-Dot production?
   CMOs handle manufacturing, packaging, and quality control processes, often specializing in transdermal systems, to meet increased demand or regional regulatory requirements.

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References

1. [1] AbbVie website, product portfolio.
2. [2] FDA, Pharmaceutical Quality Standards.
3. [3] European Medicines Agency, API sourcing guidelines.
4. [4] Market research reports on hormone replacement therapies.
5. [5] Industry publications on transdermal drug manufacturing.