Suppliers and packagers for concerta

concerta

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121	NDA	Janssen Pharmaceuticals, Inc.	50458-585-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-585-01)	2000-08-01
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121	NDA	Janssen Pharmaceuticals, Inc.	50458-586-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-586-01)	2000-08-01
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121	NDA	Janssen Pharmaceuticals, Inc.	50458-587-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-587-01)	2000-08-01
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121	NDA	Janssen Pharmaceuticals, Inc.	50458-588-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-588-01)	2000-08-01

Suppliers for the Pharmaceutical Drug: CONCERTA

Last updated: July 28, 2025

Introduction

CONCERTA (methylphenidate hydrochloride ER) is a widely prescribed extended-release formulation primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. As a branded product, its manufacturing and supply chain involve a complex network of authorized manufacturers, contract manufacturers, and suppliers that ensure consistent quality, regulatory compliance, and supply security. Understanding the supply landscape for CONCERTA is essential for stakeholders including healthcare providers, pharmaceutical companies, and investors to assess market stability, potential supply risks, and competitive dynamics.

Manufacturers of CONCERTA

The origin of CONCERTA traces back to Novartis Pharmaceuticals, which developed and originally marketed the drug. Novartis held the patent and manufacturing rights for CONCERTA until the expiration of its patent protections in various jurisdictions, which prompted the entry of generic equivalents.

• Novartis Pharmaceuticals: Historically, Novartis was the sole producer of CONCERTA, overseeing its formulation, manufacturing, and distribution globally. The company’s manufacturing facilities are located primarily in the United States and Europe, equipped to produce high-quality, FDA-compliant products.

Transition to Generic Manufacturing

Following patent expiry, multiple generic pharmaceutical manufacturers have entered the market, producing methylphenidate ER formulations equivalent to CONCERTA. These generics are often marketed under different brand names or as unbranded products.

• Authorized Generics: Novartis and other patent holders sometimes offer authorized generics—exact chemical and formulation equivalents produced by the original manufacturer but marketed under different labels. These products are crucial in markets where patent exclusivity is still active.

• Generic Manufacturers: Numerous companies manufacture methylphenidate ER formulations derived from ablated patents, often utilizing different delivery technologies such as osmotic push-pull or matrix systems. Notable manufacturers include:

  • Impax Laboratories: Known for its Abbreviated New Drug Application (ANDA) filings for methylphenidate ER formulations, supplying both branded and generic markets.
  • Sandoz (Novartis division): As part of Novartis, maintains manufacturing capacity for generic methylphenidate products.
  • Teva Pharmaceutical Industries: A leading producer of generics with methylphenidate ER variants on the market.
  • Mallinckrodt Pharmaceuticals: Operates in the ADHD treatment space, including methylphenidate ER formulations.
  • Other regional and local manufacturers: In markets like Europe, Asia, and Latin America, local manufacturers also supply methylphenidate ER products, sometimes under different brand names.

Supply Chain Complexity

The supply of CONCERTA and its equivalents involves:

• Active Pharmaceutical Ingredient (API) Suppliers: The core of manufacturing hinges on sourcing high-quality methylphenidate API, often manufactured by specialized chemical suppliers in Asia, especially China and India. Leading API providers include:

  • Hubei Sanonda (China)
  • Shenzhen Hairun Pharmaceutical (China)
  • Millennium Chemical (India)
  • Roussel Uclaf and other European API suppliers may also participate in the supply chain, depending on regional manufacturing needs.

• Formulation and Manufacturing: WHO-GMP-certified facilities for formulation, incorporating controlled-release technologies like osmotic pumps or matrix systems, are dispersed globally. The technological differences among formulators influence supply stability and patent litigation.

• Distribution and Logistics: Final distribution channels involve third-party logistics providers, wholesalers, and specialty pharmacies. Regulatory authorities like the FDA (U.S.) and EMA (Europe) monitor manufacturing compliance, impacting supply continuity.

Regulatory and Patent Considerations

Patent landscape significantly influences supplier dynamics:

• Patent Expiry: The original patent for CONCERTA expired in the U.S. in 2016, opening the market for generics. In other territories, patent expiration varies (e.g., patents lasting until 2025 in some European jurisdictions), governing when new suppliers can enter the market.

• Regulatory Approvals: Manufacturers must secure approvals through the FDA’s ANDA pathway for generics in the U.S. or equivalent processes elsewhere, establishing equivalency and safety standards.

• Legal Challenges: Patent litigations and settlement agreements sometimes restrict or delay generic entry, affecting the availability of suppliers.

Market Dynamics and Supply Security

The supply chain's robustness directly affects market availability, drug pricing, and patient access:

• Market Competition: Multiple generic manufacturers foster price competition, but supply shortages can occur due to manufacturing disruptions, regulatory delays, or raw material scarcity.

• Supply Chain Risks: Dependence on API sourced from China and India introduces geopolitical and supply stability risks. Disruptions from pandemics, trade policies, or quality issues can impact drug availability.

• Recent Trends: The COVID-19 pandemic strained global supply chains, leading to temporary shortages of methylphenidate ER formulations in some regions. Manufacturers are increasingly diversifying API sourcing and investing in manufacturing capacity.

Strategic Implications for Stakeholders

• Healthcare Providers: Should monitor formulary updates, especially if shortages of CONCERTA occur, to ensure uninterrupted treatment options.

• Pharmaceutical Companies: Must evaluate supplier reliability, regulatory status, and technological capabilities when entering or expanding in the methylphenidate ER market.

• Investors: Should consider patent expiry timelines, the entry of generic competitors, and supply chain stability as critical factors influencing market valuation.

Conclusion

The supply landscape for CONCERTA is characterized by a primary originator (Novartis) followed by a diverse array of generic manufacturers supported by global API suppliers and formulation specialists. The dynamics are heavily influenced by patent status, regulatory pathways, and geopolitical factors affecting raw material sourcing. Ensuring supply stability requires continuous risk mitigation strategies by manufacturers, diversified sourcing, and adherence to regulatory standards.

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Key Takeaways

• CONCERTA was originally produced by Novartis, with the patent expiring in key markets, opening the market for multiple generics.
• Major generic manufacturers include Impax, Sandoz, Teva, and Mallinckrodt, supported by Asian API providers.
• The supply chain relies heavily on sourcing methylphenidate API from Chinese and Indian suppliers, introducing geopolitical risks.
• Patent expiry and regulatory approvals are primary drivers influencing the number of suppliers and market competitiveness.
• Ongoing supply vulnerabilities, highlighted during the COVID-19 pandemic, underscore the importance of supply chain diversification for sustained drug availability.

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FAQs

1. Who are the primary suppliers of CONCERTA’s active ingredient?
Most methylphenidate hydrochloride API is sourced from major Asian manufacturers in China and India, such as Hubei Sanonda and Shenzhen Hairun Pharmaceutical.

2. Can other companies produce generic versions of CONCERTA?
Yes. Post-patent expiry, multiple manufacturers have developed and marketed generic methylphenidate ER formulations, subject to regulatory approval and patent litigation outcomes.

3. How do patent protections impact the supply chain?
Patent protections delay entry of generics, limiting supply options and maintaining higher prices. Patent expiration enables increased manufacturing and competition, expanding supply sources.

4. Are there supply risks associated with manufacturing CONCERTA?
Yes. Risks include API supply disruptions, regulatory delays, quality issues, and geopolitical factors affecting raw material sourcing, all of which can lead to shortages.

5. How is the supply chain for methylphenidate ER formulations evolving?
Manufacturers are diversifying API suppliers, investing in technological innovation for generic formulations, and enhancing logistical resilience to mitigate supply disruptions.

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Sources

[1] FDA’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] Novartis Official Website.
[3] IMPAX Laboratories filings and product portfolio.
[4] Teva Pharmaceuticals corporate disclosures.
[5] Market analyses on ADHD medication manufacturing and supply chain.