Last updated: July 30, 2025
Introduction
DYANAVEL XR 15 is a long-acting formulation of amphetamine used primarily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adult populations. As a patented pharmaceutical product, DYANAVEL XR 15's supply chain involves multiple stakeholders, including original drug manufacturers, authorized distributors, and secondary generic suppliers. Understanding the landscape of suppliers is critical for stakeholders in procurement, distribution, and regulatory compliance.
Manufacturers of DYANAVEL XR 15
Genomma Lab International
Originally, DYANAVEL XR was developed and commercialized by Aphena Pharma Solutions in collaboration with Shire plc (now part of Takeda Pharmaceutical Company Limited). The primary manufacturer responsible for the commercial production of DYANAVEL XR 15 is typically Genomma Lab International, a leading pharmaceutical company specializing in niche therapeutic areas and extended-release formulations.
- Manufacturing facilities: Genomma Lab operates state-of-the-art manufacturing plants in Mexico and other regions, adhering to Good Manufacturing Practices (GMP) standards, ensuring product quality and regulatory compliance.
- Quality assurance: The manufacturer maintains rigorous quality controls to meet both FDA and international standards, critical for controlled substances like amphetamines.
Contract Manufacturing Organizations (CMOs)
Given the complexity of extended-release formulations, drug companies often source manufacturing services from CMOs. These organizations may produce DYANAVEL XR 15 on behalf of the primary licensee under strict contractual quality stipulations.
- Examples include: Patheon (a part of Thermo Fisher Scientific), Recipharm, and other global CMO entities specializing in controlled-release pharmaceuticals.
Authorized Distributors and Supply Channels
Pharmaceutical Wholesalers
Authorized distributors play a critical role in ensuring DYANAVEL XR 15 reaches healthcare facilities and pharmacies efficiently. These include:
- McKesson Corporation
- AmerisourceBergen
- Cardinal Health
These major distributors obtain product directly from licensed manufacturers or authorized batch producers and distribute to hospitals, clinics, and retail pharmacies.
Specialty Pharmacies
Given DYANAVEL XR 15’s controlled substance status, specialty pharmacies with appropriate handling and storage capabilities often supply the medication for complex cases or hospital-based dispensing.
International Suppliers
In regions outside North America, authorized regional distributors and importers facilitate access. Their suppliers are often licensed manufacturers adhering to local regulatory standards, such as Health Canada, the European Medicines Agency (EMA), or the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Generic and Biosimilar Suppliers
While DYANAVEL XR 15 remains proprietary, several firms seek to develop generic or biosimilar formulations once patent protections expire.
Emerging Generic Manufacturers
- Larkspur Health Sciences
- Suzhou Zelgen Biopharmaceuticals
- Aurobindo Pharma
These organizations are investing in extended-release amphetamine formulations, but regulatory approvals and manufacturing licenses for DYANAVEL XR 15 specifically are required.
Regulatory Barriers
The controlled-substance classification of DYANAVEL XR 15 poses significant hurdles for generic manufacturers due to stringent regulations governing manufacturing, distribution, and prescribing.
Regulatory and Patent Considerations
Patent Exclusivity
DYANAVEL XR 15's patent protections provide exclusivity for the original manufacturer, delaying generic entry. In the U.S., patents typically last 20 years from filing, with market exclusivity granted until patent expiry.
Regulatory Approvals
Manufacturers and suppliers must obtain approval from respective authorities:
- FDA (U.S. Food and Drug Administration)
- EMA (European Medicines Agency)
- Health Canada
- PMDA (Japan)
Approval involves demonstrating bioequivalence, manufacturing quality, and safety, especially critical for controlled substances.
Supply Chain Challenges
Controlled Substance Regulations
Strict regulatory oversight of amphetamine-based medications limits the number of authorized manufacturing and distribution channels, constraining supply and increasing compliance costs.
Global Supply Constraints
Pandemic disruptions, geopolitical issues, and raw material shortages can impact the supply of active pharmaceutical ingredients (APIs), affecting manufacturing capacity.
Market Demand Dynamics
Rising ADHD diagnoses and long-acting medication preferences increase demand, straining existing supply lines and prompting new entrants cautiously entering the market under tight regulatory conditions.
Key Takeaways
-
Primary manufacturing: Genomma Lab is the primary manufacturer of DYANAVEL XR 15, with potential involvement from CMOs specializing in controlled-release formulations.
-
Distribution channels: Authorized wholesalers such as McKesson, AmerisourceBergen, and Cardinal Health serve as the main distributors within North America.
-
Regulatory barriers: Patent protections and controlled substance regulations significantly influence supply chain dynamics, limiting generic competition and tightening import/export pathways.
-
Global supply considerations: Raw material availability, manufacturing capacity, and pandemic-related disruptions present ongoing challenges.
-
Future outlook: Patent expiry and increased demand may catalyze more generic manufacturers entering the market, diversifying the supplier base.
FAQs
-
Who are the primary suppliers of DYANAVEL XR 15?
The main manufacturer is Genomma Lab International, supplemented by CMOs specializing in controlled-release formulations. Distributors like McKesson and AmerisourceBergen handle widespread distribution.
-
Can I obtain DYANAVEL XR 15 from overseas suppliers?
Due to regulatory restrictions on controlled substances, importing DYANAVEL XR 15 involves strict compliance with national laws. Authorized regional distributors are the proper channels within legal frameworks.
-
Are there generic equivalents of DYANAVEL XR 15?
Currently, DYANAVEL XR 15 remains under patent protection, with no approved generic equivalents. Future market entrants may emerge post-patent expiry, subject to regulatory approval.
-
What regulatory hurdles limit the entry of new suppliers?
Stringent controlled substance licensing, GMP requirements, and bioequivalence standards act as substantial barriers for new manufacturers seeking approval.
-
How might supply chain disruptions impact DYANAVEL XR 15 availability?
Disruptions in raw material supply, manufacturing capacity constraints, and geopolitical factors can lead to shortages or delays in product availability.
References
[1] U.S. Food and Drug Administration (FDA). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[2] Takeda Pharmaceutical Company Limited. Product portfolio and licensing agreements.
[3] International Narcotics Control Board (INCB). Guidelines on controlled substance manufacturing and distribution.
[4] McKesson Corporation. Pharmaceutical distribution services.
[5] European Medicines Agency (EMA). Regulatory requirements for controlled substances.
