dexmethylphenidate hydrochloride; serdexmethylphenidate chloride: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994	NDA	Corium, LLC.	65038-286-99	100 CAPSULE in 1 BOTTLE, PLASTIC (65038-286-99)	2021-07-16
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994	NDA	Corium, LLC.	65038-429-99	100 CAPSULE in 1 BOTTLE, PLASTIC (65038-429-99)	2021-07-16
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994	NDA	Corium, LLC.	65038-561-99	100 CAPSULE in 1 BOTTLE, PLASTIC (65038-561-99)	2021-07-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for central nervous system (CNS) stimulants, particularly dexmethylphenidate hydrochloride and its extended-release counterpart, serdexmethylphenidate chloride, is highly competitive and regulated. These drugs are primarily indicated for Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy, with dexmethylphenidate being a potent methylphenidate enantiomer. Recognized for their efficacy, these medications' manufacturing and supply chains involve a complex network of licensed pharmaceutical companies, generic manufacturers, and contract manufacturing organizations (CMOs).

This report provides a comprehensive overview of current suppliers for dexmethylphenidate hydrochloride and serdexmethylphenidate chloride, emphasizing licensed manufacturers, generic entrants, and recent market developments. An understanding of these suppliers offers insights into market competition, regulatory status, and patient access.

Regulatory Status and Market Overview

Dexmethylphenidate Hydrochloride

Dexmethylphenidate hydrochloride, marketed under brands like Focalin and Focalin XR, was developed by Novartis (now part of Teva Pharmaceuticals following various acquisitions). It holds FDA approval for ADHD treatment, with patent protections and licensing established in the early 2000s. Generic versions emerged post-patent expiry, escalating competition and broadening the supply base.

Serdexmethylphenidate Chloride

Serdexmethylphenidate, branded as Azstarys (by Arbor Pharmaceuticals and its licensee, Greenstone), is a prodrug designed for extended-release formulations. It was approved by the FDA in 2021, representing a relatively newer entrant in the stimulant market. Its development involved novel prodrug technology, emphasizing the importance of specialized manufacturing capabilities among its suppliers.

Key Suppliers of Dextmethylphenidate Hydrochloride

1. Original Brand Manufacturers

Novartis/Alcon (Historical)
Originally developed, but Novartis sold its generic division, including dexmethylphenidate products, to other firms during the 2010s. Currently, the brand Focalin is marketed primarily by Teva Pharmaceuticals [1].

2. Major Generic Manufacturers

Teva Pharmaceuticals
As the primary licensee, Teva manufactures and markets dexmethylphenidate hydrochloride instant-release and XR versions globally, leveraging production facilities across the US and Europe. Their strong presence ensures widespread patient access.
Mallinckrodt Pharmaceuticals
Previously a notable manufacturer of generic methylphenidate formulations, including dexmethylphenidate, though recent market exit and restructuring have shifted their focus away from stimulant production.
Sandoz (Novartis division)
As a generic arm of Novartis, Sandoz historically supplied dexmethylphenidate, although its role has diminished since the sale of Novartis generics to other companies.
Lupin Pharmaceuticals
An Indian pharmaceutical manufacturer, Lupin produces generic methylphenidate products, including dexmethylphenidate formulations, targeting international markets.
Aurobindo Pharma
Active in multiple countries, Aurobindo offers generic dexmethylphenidate hydrochloride, primarily for markets outside the US.
Sun Pharmaceutical Industries
Supplies generic methylphenidate derivatives, including dexmethylphenidate, through its global manufacturing network.

3. Contract Manufacturing Organizations (CMOs)

Catalent Pharma Solutions
Provides development, formulation, and manufacturing services for dexmethylphenidate products, especially for generics and complex formulations.
Recipharm
Offers manufacturing services including controlled-release formulations, supporting the production of dexmethylphenidate XR.

Suppliers of Serdexmethylphenidate Chloride

1. Innovator and Licensee

Greenstone (a Pfizer company)
Developed and markets Azstarys, the first FDA-approved extended-release formulation containing serdexmethylphenidate. Greenstone's manufacturing facilities focus on complex controlled-release prodrug formulations, emphasizing purity and stability.
Arbor Pharmaceuticals
Collaborates with Greenstone for distribution and clinical development, though the manufacturing process is primarily handled by Greenstone.

2. Contract and Specialty Manufacturers

Recipharm and Catalent
Both providers support manufacturing of serdexmethylphenidate, especially in formulation development and scale-up phases. Their expertise in prodrug technologies guarantees supply consistency and compliance.

Emerging and Market Entry Players

With the recent FDA approval of serdexmethylphenidate, several companies are entering the market or expanding their manufacturing capacity:

Hikma Pharmaceuticals
Has shown interest in stimulant drugs, including methylphenidate formulations, though specific serdexmethylphenidate manufacturing approvals are pending.
Mylan (now Viatris)
Is evaluating production capacity for similar CNS stimulants, potentially entering the market for generic or biosimilar versions.
Pharmaceutical Contract Manufacturers
Companies like Endo International and Lupin are investing in manufacturing capabilities for extended-release CNS stimulants, including potential formulations of serdexmethylphenidate.

Supply Chain Challenges and Considerations

Regulatory Compliance: Manufacturing of methylphenidate derivatives, especially prodrugs like serdexmethylphenidate, requires stringent adherence to DEA regulations and FDA Good Manufacturing Practices (GMP).
API Availability: Active pharmaceutical ingredient (API) supply is complex due to the synthesis of specific enantiomers and prodrug components, involving multi-step processes and specialized facilities.
Market Dynamics: Patent expirations and the approval of new formulations stimulate generic manufacturing, increasing competition but also presenting manufacturing scale challenges.
Collaborations & Licensing: Strategic licensing agreements between originators and generics significantly influence supplier dominance and market access.

Conclusion

The supply landscape for dexmethylphenidate hydrochloride is robust, led predominantly by Teva Pharmaceuticals, supported by several international generic manufacturers like Lupin, Aurobindo, and Sandoz. For serdexmethylphenidate chloride, Greenstone (Pfizer) remains the sole primary supplier, with manufacturing capacity expanding as the drug gains approvals and market penetration.

The supply chain is characterized by a combination of brand owners, generic pharmaceutical companies, and specialized CMOs, all navigating regulatory complexities, technological demands, and market competition. As demand for CNS stimulants grows, especially with the advent of novel formulations like serdexmethylphenidate, supply chains are expected to evolve, emphasizing manufacturing agility and regulatory compliance.

Key Takeaways

Teva leads in dexmethylphenidate hydrochloride supply, supported by global manufacturing networks.
Generic manufacturers such as Lupin, Aurobindo, and Sun are expanding their roles, increasing market competition.
Serdexmethylphenidate supply is primarily controlled by Greenstone (Pfizer), with manufacturing capacity poised for growth post-approval.
Regulatory hurdles and API sourcing complexities influence supply stability and market entry.
Contract manufacturing organizations like Catalent and Recipharm are critical to scaling production and innovating formulations.

FAQs

Who are the primary producers of dexmethylphenidate hydrochloride globally?
The leading producers include Teva Pharmaceuticals, Lupin, Aurobindo Pharma, and Sun Pharmaceutical Industries, supported by various CMOs.
Is serdexmethylphenidate chloride widely available?
As of 2023, serdexmethylphenidate is primarily supplied by Greenstone (a Pfizer entity) after FDA approval in 2021. Market availability continues to expand.
What regulatory considerations affect the supply of these drugs?
Both drugs are controlled substances regulated by the DEA and require strict compliance with GMP, along with adherence to international and local health authorities’ guidelines.
Are there generic versions of serdexmethylphenidate on the market?
Currently, there are no generics; Greenstone is the sole approved manufacturer. Future entrants may emerge as the market matures.
How might supply chain disruptions impact patient access?
API shortages, manufacturing delays, or regulatory changes can hamper supply, making diversified manufacturing sources and strong regulatory oversight critical to ensuring patient access.

References
[1] U.S. Food and Drug Administration. Focalin and Focalin XR approval notices. 2005-2021.

Suppliers and packagers for generic pharmaceutical drug: dexmethylphenidate hydrochloride; serdexmethylphenidate chloride