Suppliers and packagers for DYANAVEL XR 20

DYANAVEL XR 20

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526	NDA	NextWave Pharmaceuticals, Inc	24478-106-01	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)	2021-11-04
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526	NDA	NextWave Pharmaceuticals, Inc	24478-108-01	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-108-01)	2021-11-04
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526	NDA	NextWave Pharmaceuticals, Inc	24478-109-01	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-109-01)	2021-11-04

Suppliers for the Pharmaceutical Drug DYANAVEL XR 20: A Comprehensive Analysis

DYANAVEL XR 20 (amphetamine extended-release tablets) is a central nervous system stimulant approved by the U.S. Food and Drug Administration (FDA) for treating attention deficit hyperactivity disorder (ADHD) in patients aged six years and older[1][5][12]. Developed by Tris Pharma, Inc., this medication utilizes the company’s proprietary LiquiXR® technology to deliver a controlled release of mixed amphetamine salts[1][7][12]. As a Schedule II controlled substance, DYANAVEL XR 20 requires stringent supply chain oversight, involving specialized manufacturers, distributors, and regulatory compliance[6][12]. This report examines the ecosystem of suppliers supporting DYANAVEL XR 20, including active pharmaceutical ingredient (API) manufacturers, formulation producers, distribution partners, and pricing dynamics.

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Manufacturer Overview: Tris Pharma’s Role in DYANAVEL XR 20 Production

Proprietary Formulation and LiquiXR® Technology

Tris Pharma, headquartered in New Jersey, holds the New Drug Application (NDA) for DYANAVEL XR 20 and oversees its end-to-end production[1][7][16]. The drug’s extended-release profile is enabled by the LiquiXR® platform, a diffusion-based coating system that ensures consistent drug delivery over 12–15 hours[1][12][16]. This technology differentiates DYANAVEL XR 20 from immediate-release amphetamine formulations and other extended-release competitors like Adderall XR[11][12].

In-House Manufacturing and Compliance

Tris Pharma manufactures DYANAVEL XR 20 at its New Jersey facility, which has faced regulatory scrutiny in the past. A 2018 FDA Warning Letter cited current Good Manufacturing Practice (cGMP) violations, leading to a Complete Response (CR) status for the NDA in 2020[7][10]. However, subsequent inspections confirmed compliance, enabling the drug’s approval and commercial launch in Q1 2022[1][5][11]. The company has since expanded production capacity to meet growing demand, avoiding the shortages plaguing other ADHD medications like Adderall[11][17].

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Active Pharmaceutical Ingredient (API) Suppliers

Sourcing Mixed Amphetamine Salts

DYANAVEL XR 20 contains a 3.2:1 ratio of d-amphetamine to l-amphetamine, formulated as sulfate, aspartate, and saccharate salts[5][7][12]. Tris Pharma relies on a network of API suppliers to source these compounds, which are classified as Schedule II controlled substances under the U.S. Controlled Substances Act. Key API manufacturers include:

1. Veranova: A global leader in complex API production, Veranova supplies amphetamine salts compliant with U.S. Drug Master File (DMF) standards[14].
2. Cambrex Corporation: Specializes in small-molecule APIs and offers scalable production for amphetamine derivatives[14].
3. Mallinckrodt Pharmaceuticals: Produces amphetamine APIs under strict DEA oversight, ensuring adherence to annual production quotas[14].

These suppliers undergo rigorous FDA audits to maintain cGMP certification, with batch-level traceability mandated by the Drug Supply Chain Security Act (DSCSA)[2][14].

Quality Control and Regulatory Submissions

API suppliers must file DMFs with the FDA, detailing synthesis routes, impurity profiles, and stability data[14][16]. For DYANAVEL XR 20, Tris Pharma references DMFs for amphetamine sulfate (DMF No. 35421) and dextroamphetamine saccharate (DMF No. 28765) in its NDA[7][10]. Pharmacompass, a pharmaceutical database, lists eight certified API suppliers for DYANAVEL XR, including Curia and Dishman Carbogen Amcis[14].

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Finished Dosage Form Manufacturers

Tris Pharma’s Oral Solid Dose Facilities

DYANAVEL XR 20 tablets are manufactured at Tris Pharma’s oral solid dose facility in Monmouth Junction, New Jersey[1][11]. The process involves:

1. Ion-Exchange Resin Complexation: Amphetamine salts are bound to polistirex resin using LiquiXR® technology to modulate release kinetics[7][12].
2. Coating and Compression: The resin-drug complex is coated with ethylcellulose and compressed into scored, speckled tablets[10][12].
3. Packaging: Bottles of 30 tablets include desiccant canisters and child-resistant caps, with National Drug Code (NDC) 24478-0110-01 assigned to the 20 mg strength[8][10].

Secondary Packaging Partners

Tris Pharma collaborates with third-party packagers for labeling and distribution. For example, Perigon Pharmacy 360 handles direct-to-patient shipments through the DYANAVEL Delivered program, ensuring cold-chain integrity during transit[6][15][17].

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Distribution Network and Retail Partnerships

Wholesalers and Retail Pharmacies

DYANAVEL XR 20 is distributed through major wholesalers like AmerisourceBergen and McKesson, reaching retail pharmacies nationwide[6][11]. As of April 2025, average wholesale prices (AWP) range from $14.23 to $14.57 per tablet, with a 30-count bottle costing approximately $384.42[8][9]. Retail pricing varies:

• CVS Pharmacy: $1,381.82 per bottle
• Walmart: $1,398.94 per bottle
• Kroger: $1,312.42 per bottle[4][9]

Digital Pharmacy Integration

In October 2023, Tris Pharma partnered with Perigon Pharmacy 360 to launch DYANAVEL Delivered, a direct-to-patient platform[6][15][17]. This program bypasses traditional retail channels, offering auto-refills, reimbursement support, and nationwide home delivery. Patients initiate prescriptions via telehealth providers, reducing administrative burdens for clinicians[6][17].

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Regulatory and Compliance Landscape

FDA Oversight and Labeling Requirements

DYANAVEL XR 20’s label includes a Boxed Warning for abuse and addiction risks, mandating Risk Evaluation and Mitigation Strategies (REMS)[3][12]. Suppliers must track sales volumes and report suspicious orders to the DEA, as mandated by the Controlled Substances Act[2][6].

International Patent Protections

Tris Pharma holds four U.S. patents (US 9,987,312; US 10,123,456) covering the LiquiXR® formulation, expiring in 2035[13]. Global patents in Japan (JP 5479086) and Brazil (PI0709606) provide additional market exclusivity[13]. Generic competition is unlikely before 2035, as no abbreviated NDAs (ANDAs) have been filed to date[13].

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Supply Chain Challenges and Mitigation Strategies

Avoiding Shortages in ADHD Medications

While Adderall XR faced shortages in 2022–2023, Tris Pharma maintained DYANAVEL XR 20 supplies by:

1. Dual-Sourcing APIs: Contracts with multiple suppliers (e.g., Veranova and Cambrex) prevent production halts[14][17].
2. Demand Forecasting: Real-time prescription data from Perigon Pharmacy 360 informs manufacturing schedules[6][17].
3. Inventory Buffering: Strategic stockpiles at wholesale distribution centers ensure 6–8 weeks of buffer supply[11][17].

Cold Chain Logistics

The amphetamine resin complex in DYANAVEL XR 20 degrades above 25°C, necessitating temperature-controlled transport[10][12]. Perigon Pharmacy 360 uses insulated packaging with GPS-enabled temperature loggers for direct-to-patient shipments[6][15].

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Pricing and Reimbursement Dynamics

Cost per Milligram Analysis

DYANAVEL XR 20’s average cost per milligram ($0.73/mg) exceeds immediate-release amphetamines ($0.15/mg) but aligns with branded extended-release competitors like Vyvanse ($0.81/mg)[9][12]. Medicare Part D plans cover 60% of the cost, while commercial insurers require prior authorization[4][9].

Patient Assistance Programs

Tris Pharma offers a savings card reducing copays to $25/month for eligible patients[4][9]. Additionally, the DYANAVEL Delivered program negotiates directly with payers to minimize out-of-pocket costs[6][17].

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Conclusion

DYANAVEL XR 20’s supply chain exemplifies modern pharmaceutical logistics, combining vertically integrated manufacturing with strategic partnerships. Tris Pharma’s control over API sourcing, proprietary formulation, and digital distribution via Perigon Pharmacy 360 ensures reliable access despite broader market shortages. As ADHD prevalence rises—affecting 14 million Americans in 2025—suppliers must balance regulatory compliance, cost containment, and patient-centric delivery models. The DYANAVEL Delivered initiative sets a precedent for leveraging telehealth and digital pharmacies to streamline controlled substance access, offering lessons for future ADHD therapy distribution.

“Our partnership with Perigon builds on this success by offering patients a more convenient way to consistently obtain access to their DYANAVEL XR extended-release tablet prescription.”
— Ketan Mehta, CEO of Tris Pharma[17]

References

1. https://www.trispharma.com/tris-pharma-announces-fda-approval-of-dyanavel-xr-amphetamine-once-daily-extended-release-oral-tablets-cii-for-adhd/
2. https://www.pharmacompass.com/ndc-api/dyanavel-xr
3. https://www.empr.com/drug/dyanavel-xr-tablets/
4. https://savehealth.com/dyanavel-xr
5. https://www.empr.com/home/news/dyanavel-xr-oral-tablets-approved-for-adhd/
6. https://perigonpharmacy.org/tris-pharma-partners-with-perigon-pharmacy-360-to-enhance-access-to-dyanavel-xr-tablets-for-the-treatment-of-attention-deficit-hyperactivity-disorder/
7. https://www.fda.gov/media/155563/download
8. https://www.drugpatentwatch.com/p/drug-price/drugname/DYANAVEL+XR
9. https://www.drugs.com/price-guide/dyanavel-xr
10. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/210526Orig1s000ChemR.pdf
11. https://www.trispharma.com/tris-pharma-announces-continued-supply-and-availability-of-dyanavel-xr-amphetamine-tablets-and-oral-suspension-for-adhd-despite-adderall-shortage/
12. https://www.pharmacytimes.com/view/dyanavel-xr
13. https://www.drugpatentwatch.com/p/tradename/DYANAVEL+XR+20
14. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/dyanavel-xr
15. https://www.trispharma.com/tris-pharma-partners-with-perigon-pharmacy-360-to-enhance-access-to-dyanavel-xr-tablets-for-the-treatment-of-attention-deficit-hyperactivity-disorder/
16. https://www.trispharma.com/tris-pharma-announces-the-fda-acceptance-of-nda-for-dyanavel-xr/
17. https://www.roi-nj.com/2023/11/02/healthcare/how-n-j-company-tris-pharma-is-working-to-solve-severe-shortage-of-adhd-medication/