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Suppliers and packagers for BENICAR HCT
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BENICAR HCT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0863-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0863-30) | 2022-09-01 |
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0864-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0864-30) | 2022-09-01 |
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0865-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0865-30) | 2022-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BENICAR HCT
Introduction
Benicar HCT (olmesartan medoxomil with hydrochlorothiazide) is a combination medication widely prescribed for managing hypertension. As a pivotal drug, its supply chain involves numerous pharmaceutical manufacturers, distributors, and authorized generic producers. Ensuring a stable supply chain is critical for healthcare providers, payers, and patients. This comprehensive analysis delineates key suppliers for Benicar HCT, explores their market presence, and highlights factors influencing supply stability.
Manufacturers of Benicar HCT
Benicar HCT is primarily produced through licensing agreements and manufacturing arrangements involving multiple pharmaceutical companies worldwide. The originator of the active ingredients and branded product is Daiichi Sankyo, which markets Benicar HCT under its brand name. Several generic manufacturers also produce bioequivalent versions following patent expirations and regulatory approvals.
Authorized Generic and Patent Landscape
Daiichi Sankyo holds the patent rights for Benicar HCT, but after patent expiry, the drug entered the generic market, expanding the supplier base significantly. Generic manufacturers licensed by patent holders typically seek approval from regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Key Suppliers and Manufacturers
1. Daiichi Sankyo, Inc.
Role: Original Brand Manufacturer
Market Presence: As the patent holder, Daiichi Sankyo remains a primary source for branded Benicar HCT, controlling manufacturing, distribution, and global licensing agreements. The company ensures quality and consistent supply through its manufacturing facilities in Japan and the U.S. ([1]).
2. Mylan (now part of Viatris)
Role: Generic Manufacturer
Market Presence: Mylan was among the first to produce generic versions post-patent expiration. Its production facilities in the U.S. and other regions supply affordable alternatives to the original branded drug. Viatris, the merged entity, continues to supply Benicar HCT generics ([2]).
3. Teva Pharmaceuticals
Role: Generic Manufacturer
Market Presence: Teva is a major global generic producer with facilities in Israel and the U.S., offering bioequivalent versions of olmesartan medoxomil with hydrochlorothiazide. Its extensive distribution network ensures widespread availability ([3]).
4. Sun Pharma
Role: Generics Producer
Market Presence: Sun Pharma, headquartered in India, produces generic olmesartan HCT formulations, serving markets across Asia, the Middle East, and expanding into Europe and North America. Its manufacturing capabilities focus on high-volume production ([4]).
5. Sandoz (Novartis)
Role: Generic Producer
Market Presence: Sandoz supplies generic olmesartan HCT in multiple markets, leveraging its global manufacturing footprint to ensure supply chain robustness and regulatory compliance ([5]).
6. Other Notable Suppliers
Additional manufacturers include Dr. Reddy’s Laboratories, Lupin, and Abbott Laboratories, which produce generic versions for regional markets, contributing to supply diversification and price competitiveness.
Supply Chain Dynamics and Market Factors
Patent Expiry and Market Entry
Post-patent expiration, the entry of multiple generic suppliers has increased market competition, which generally stabilizes supply while driving prices downward. However, manufacturing capacity, regulatory approvals, and raw material availability can influence supply consistency.
Regulatory Approvals and Quality Assurance
Suppliers must meet stringent quality standards defined by agencies like FDA (U.S.) and EMA (Europe). Any regulatory scrutiny or manufacturing deficiencies can temporarily disrupt supply.
Raw Material Sourcing
Active pharmaceutical ingredients (APIs) for olmesartan medoxomil and hydrochlorothiazide are sourced globally. Disruptions in supply chains for these raw materials, due to geopolitical issues or COVID-19-related disruptions, can impact production.
Market Demand and Pre-market Approval
Surge in hypertension prevalence and guidelines promoting combination therapy increase demand for Benicar HCT, affecting supplier production planning.
Global Distribution and Regional Availability
Suppliers operate globally, with regional market dominance varying:
- United States: Major suppliers include Daiichi Sankyo, Mylan/Viatris, Teva, and Sandoz.
- Europe: Sandoz, Novartis, and local generics manufacturers dominate.
- Asia: Sun Pharma, Lupin, Dr. Reddy’s play significant roles.
- Emerging Markets: Various regional suppliers ensure product availability despite logistical challenges.
Market Challenges Impacting Suppliers
- Pricing Pressures: Increased generic competition affects profit margins; suppliers optimize manufacturing efficiencies.
- Regulatory Hurdles: Stringent approval processes may delay new entrants or alternative formulations.
- Supply Chain Disruptions: Raw material shortages and logistical issues, especially amid geopolitical tensions and pandemics.
- Patent Litigation: Ongoing patent disputes can influence licensing agreements and market entry timelines.
Concluding Remarks
Multiple global manufacturers supply Benicar HCT, with primary suppliers including Daiichi Sankyo (brand), Mylan/Viatris, Teva, Sun Pharma, and Sandoz (generics). The broad supplier base promotes supply stability but depends heavily on regulatory compliance, raw material availability, and market demand dynamics. Strategic diversification of sourcing and continuous monitoring of regulatory developments are essential for stakeholders to mitigate supply risks.
Key Takeaways
- Daiichi Sankyo remains the primary brand supplier with an extensive licensing network for generics.
- Major generic manufacturers like Mylan/Viatris, Teva, Sun Pharma, and Sandoz dominate the supply landscape post-patent expiry.
- Supply stability hinges on raw material sourcing, regulatory approvals, and geopolitical factors.
- Global distribution varies but is generally resilient due to multiple regional suppliers.
- Market pressures necessitate continuous supply chain optimization and diversification strategies for stakeholders.
FAQs
1. Who are the primary manufacturers of Benicar HCT today?
Major suppliers include Daiichi Sankyo (original manufacturer), along with generics from Mylan/Viatris, Teva, Sun Pharma, and Sandoz.
2. How does patent expiry impact Benicar HCT supply?
Patent expiry enables multiple generic manufacturers to produce bioequivalent versions, increasing supply options but also intensifying market competition and price pressures.
3. Are there regional differences in Benicar HCT suppliers?
Yes; regional prominence of suppliers such as Sun Pharma in Asia and Sandoz in Europe reflects market demand and manufacturing localization.
4. What factors influence the stability of Benicar HCT supply?
Regulatory approvals, raw material availability, manufacturing capacity, geopolitical issues, and market demand are key influencing factors.
5. How can stakeholders mitigate supply risks for Benicar HCT?
Diversifying suppliers, maintaining quality compliance, monitoring raw material sources, and engaging with regional distributors are effective strategies.
References
[1] Daiichi Sankyo Corporate Website. Overview of Benicar HCT.
[2] Viatris Official Site. Product portfolio insights.
[3] Teva Pharmaceuticals Annual Reports.
[4] Sun Pharma Global. Manufacturing and product details.
[5] Sandoz (Novartis) Corporate Publications. Manufacturing and distribution data.
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