Suppliers and packagers for SILENOR

SILENOR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036	NDA	Currax Pharmaceuticals LLC	42847-103-03	30 TABLET in 1 BLISTER PACK (42847-103-03)	2010-08-01
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036	NDA	Currax Pharmaceuticals LLC	42847-103-10	100 TABLET in 1 BOTTLE (42847-103-10)	2010-08-01
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036	NDA	Currax Pharmaceuticals LLC	42847-103-30	30 TABLET in 1 BOTTLE (42847-103-30)	2010-08-01
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036	NDA	Currax Pharmaceuticals LLC	42847-103-50	500 TABLET in 1 BOTTLE (42847-103-50)	2010-08-01

Suppliers for the Pharmaceutical Drug: Silenor (Doxepin)

Last updated: July 27, 2025

Introduction

Silenor, the brand name for doxepin hydrochloride, is a prescription medication primarily approved for the treatment of insomnia characterized by difficulty staying asleep. As a tricyclic antidepressant, doxepin’s sedative properties are leveraged for sleep disorders, making it a vital product within the pharmaceutical landscape. Understanding the suppliers involved in its manufacturing, distribution, and supply chain is crucial for pharmaceutical companies, healthcare providers, and market analysts aiming to navigate the complex dynamics of sleep-aid medications.

This article offers an in-depth overview of Silenor’s suppliers, encompassing active pharmaceutical ingredient (API) manufacturers, formulation and finished dosage form producers, and distribution channels. It examines the key players, their geographical presence, regulatory considerations, and supply chain strategies.

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Active Pharmaceutical Ingredient (API) Suppliers for Doxepin

The foundation of Silenor lies in its active component, doxepin hydrochloride. API manufacturing involves complex chemical synthesis, requiring high-quality standards, regulatory compliance, and robust supply chain integration.

Leading API Manufacturers

• Eli Lilly and Company: A primary producer of doxepin, Eli Lilly pioneered the original synthesis and distribution of doxepin, including formulations marketed as Silenor. The company’s global manufacturing facilities produce high-grade API, adhering to strict Good Manufacturing Practices (GMP). As a originator supplier, Lilly’s API supply remains pivotal, although it faces competition from generic manufacturers.

• Generics Manufacturers: Post patent expiration, several generic pharmaceutical companies entered the market, becoming key API suppliers. Notable players include:

  • Dr. Reddy’s Laboratories (India): Active in the production of doxepin API, leveraging cost-effective manufacturing, complying with international quality standards.
  • Sun Pharmaceutical Industries (India): Offers API manufacturing aligned with global standards, serving both domestic and international markets.
  • Lupin Ltd. (India): Provides API chemicals with regulatory approvals in major markets, contributing notably to the global supply chain.
  • Alvogen (USA/EU): Engaged in generic APIs, with manufacturing facilities in compliance with regional GMP standards.

Regulatory and Quality Considerations

API suppliers must ensure rigorous quality control, FMG compliance, and transparency under frameworks such as US FDA, EMA, and other regional authorities. The proliferation of generic API manufacturers increases supply flexibility and price competitiveness while raising the importance of stringent regulatory oversight.

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Formulation and Finished Dosage Form Manufacturers

Once the API is procured, pharmaceutical companies formulate it into the commercially available drug product. For Silenor, Eli Lilly remains the label-owner and primary manufacturer of the finished product, though multiple generic companies also produce doxepin-based sleep aids.

Original Manufacturer

• Eli Lilly and Company: As the patent holder, Lilly manages the formulation, packaging, and distribution of Silenor. Their manufacturing facilities are certified to meet high-quality standards, ensuring product consistency and efficacy. Lilly’s global distribution network enables broad availability across healthcare markets.

Generic Manufacturers

Following patent expiry, various pharmaceutical companies began producing generic doxepin hydrochloride tablets, some marketing themselves under different brand names for sleep aids.

• Mylan (now part of Viatris): A major generics producer with manufacturing sites certified for quality, supplying generic doxepin formulations to multiple regions.
• Teva Pharmaceutical Industries: Known for a broad portfolio of generics, including doxepin, with a focus on regulatory compliance and extensive distribution channels.
• Aurobindo Pharma: An Indian-based manufacturer providing cost-effective generic formulations of doxepin, expanding accessible options in emerging markets.
• Actavis (now part of Teva): Offered generic formulations widely available in the US and Europe.

Supply Chain and Production Considerations

Manufacturers of finished dosage forms must maintain rigorous adherence to GMP standards, manage raw material sourcing, and coordinate distribution channels to ensure the timely availability of Silenor and equivalent generic products.

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Distribution Channels and Market Supply

The distribution of Silenor involves multiple layers, including wholesalers, pharmacy networks, hospitals, and online pharmacies.

Key Distributors

• Major pharmaceutical wholesalers such as McKesson, AmerisourceBergen, and Cardinal Health are responsible for large-scale drug distribution in North America, providing supply chain stability for Silenor.

• International distribution network relies on regional distributors with partnerships spanning North America, Europe, Asia, and emerging markets. Manufacturers leverage these channels to ensure global product availability, often accommodating regional regulatory demands.

Market Dynamics

Supply chain disruptions, raw material shortages, or regulatory hurdles can impact Silenor’s availability. Notably, competition from generic formulations affects market pricing, driving demand for efficient supply chain management among suppliers.

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Regulatory and Patent Landscape

• Patent Status: Eli Lilly's patent protection for Silenor expired in 2018 in the U.S., opening avenues for generic manufacturers. In other jurisdictions, patent expiry dates vary, influencing regional supplier activity.
• Regulatory Approvals: Suppliers must obtain approval from regional authorities such as the FDA (U.S.), EMA (Europe), and other national agencies, ensuring compliance with quality and safety standards necessary for market authorization.

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Geographical Sourcing and Supply Chain Risks

• India and China dominate API manufacturing for generic doxepin, owing to cost-effective production and established GMP-compliant facilities.
• Europe and North America primarily host formulation and finished product manufacturing, driven by stricter regulatory standards.
• The ongoing geopolitical tensions, patent disputes, and global supply chain disruptions could impact the availability and pricing of Silenor and its generics.

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Future Outlook and Market Trends

The market for sleep aids, including Silenor, faces evolving regulatory landscapes and increasing competition from new pharmacological and non-pharmacological therapies. Suppliers investing in quality assurance, regional expansions, and supply chain resilience will be better positioned to meet market demand.

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Key Takeaways

• The API supply for doxepin, the active ingredient in Silenor, is primarily sourced from Indian and Chinese manufacturers, with Eli Lilly maintaining a significant role as the originator.
• Generic pharmaceutical companies globally have expanded production capacity, increasing supply competition and reducing prices.
• Regulatory compliance and high-quality manufacturing standards are critical for maintaining supply chain integrity across regions.
• The expiration of patent rights in several jurisdictions has significantly diversified the supplier base, facilitating broader availability.
• Supply chain risks such as raw material shortages and geopolitical factors should be proactively managed by stakeholders.

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FAQs

1. Who are the primary suppliers of doxepin API for Silenor?
Major API suppliers include Eli Lilly (originator) and several generics manufacturers such as Dr. Reddy’s, Sun Pharma, Lupin, and Aurobindo, primarily based in India and China.

2. Are there alternative suppliers for Silenor’s finished dosage forms?
Yes. Besides Eli Lilly, multiple generic manufacturers produce doxepin tablets, distributed globally through wholesale and retail channels.

3. How does patent expiry affect supplier diversity for Silenor?
Patent expiration allows generic manufacturers to produce competing formulations, broadening the supplier base and increasing supply options.

4. What regulatory considerations do suppliers need to adhere to?
Suppliers must comply with GMP standards mandated by regional agencies such as the FDA, EMA, and others, to ensure safety, efficacy, and market approval.

5. What regional factors influence the supply chain of Silenor?
Manufacturing in India and China provides cost advantages, while North America and Europe impose stricter quality standards. Geopolitical and logistical challenges can impact global supply continuity.

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References

[1] U.S. Food and Drug Administration. (2022). Drug Master Files and API Manufacturers.
[2] Eli Lilly and Company. (2022). Product information for Silenor.
[3] MarketWatch. (2021). Patent expiry and generic competition in the sleep aid market.
[4] International Pharmaceutical Industry Reports. (2022). Global API manufacturing trends.
[5] European Medicines Agency. (2022). Regulatory standards for pharmaceutical manufacturing in Europe.