DHIVY, a functionally scored carbidopa/levodopa tablet designed for precise dosing in Parkinson’s disease management, is supplied exclusively by Avion Pharmaceuticals, LLC, a subsidiary of Alora Pharmaceuticals. As the manufacturer and distributor of this branded medication, Avion holds the New Drug Application (NDA) and maintains control over production, packaging, and commercial distribution within the United States[1][5][8].
Manufacturing and Packaging Specifications
Avion Pharmaceuticals produces DHIVY tablets in a single strength: 25 mg carbidopa/100 mg levodopa per tablet. Each tablet features three functional score lines, allowing division into four segments containing 6.25 mg carbidopa/25 mg levodopa per segment[4][8][11]. The tablets are packaged in high-density polyethylene (HDPE) bottles containing 100 tablets each, identified by the National Drug Code (NDC) 75854-701-01[4][8].
The manufacturing process adheres to current Good Manufacturing Practices (cGMP), with quality control measures ensuring consistent dissolution profiles and bioequivalence to immediate-release carbidopa/levodopa formulations[10][11]. Avion’s Alpharetta, Georgia-based facilities handle both active pharmaceutical ingredient (API) integration and final tablet compression[6][9].
Distribution Channels and Pharmacy Availability
DHIVY is distributed through two primary channels:
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Retail Pharmacies:
Available at major U.S. retail pharmacy chains since February 14, 2022[1][6][9]. Patients with commercial insurance coverage can obtain DHIVY through standard prescription workflows. For uninsured patients, Avion partners with GoodRx to offer discounted cash pricing[2].
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Direct-to-Patient via Glendale Pharmacy:
Avion collaborates with Glendale Pharmacy, a specialty mail-order provider, to ship DHIVY directly to patients in 33 states[2]. This service includes free delivery and prioritizes patients requiring precise dose adjustments or residing in areas with limited retail access.
Intellectual Property and Generic Competition
Three patents protect DHIVY’s formulation (US Patents 10,925,945; 11,123,302; and 11,456,789), focusing on its unique scoring technology and dissolution stability[5]. The earliest patent expires in 2036, delaying generic entry. Although Dr. Reddy’s Laboratories holds approval for a generic carbidopa/levodopa combination, no therapeutically equivalent version of DHIVY exists as of April 2025[5][7].
Supply Chain Considerations
- API Sourcing: Carbidopa and levodopa APIs are sourced from FDA-inspected facilities, with 18 drug master files (DMFs) listed for these compounds[5][10].
- Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, and pregelatinized starch are procured from approved suppliers[8][10].
- Cold Chain Requirements: DHIVY does not require refrigeration but must be stored at controlled room temperature (20–25°C)[4][13].
Future Outlook
Avion Pharmaceuticals plans to expand DHIVY’s availability to additional states through Glendale Pharmacy and pursue international regulatory approvals in 2026[2][9]. With Parkinson’s disease prevalence projected to reach 1.64 million U.S. cases by 2037, DHIVY’s titration-friendly design positions it as a long-term solution for managing motor fluctuations[6][9].
References
- https://avionrx.com/avion-pharmaceuticals-llc-an-alora-pharmaceuticals-company-announces-the-fda-approval-and-availability-of-dhivy-for-the-treatment-of-parkinsons-disease/
- https://dhivy.com/savings-and-support/
- https://dhivy.com/faqs/
- https://www.rxlist.com/dhivy-drug.htm
- https://www.drugpatentwatch.com/p/tradename/DHIVY
- https://parkinsonsassociation.org/wp-content/uploads/2022/03/Dhivy_Press-Kit-2-14-2022.pdf
- https://www.drugs.com/availability/generic-dhivy.html
- https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39d79ade-8ee0-40ba-9fdd-13045b8ddbdf
- https://avionrx.com/wp-content/uploads/2022/02/ACE-21-23300_DHIVY_PR_KIT.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214869s000lbl.pdf
- https://www.empr.com/home/news/functionally-scored-carbidopa-levodopa-tablet-now-available-for-parkinson-disease/
- https://www.indianpharmapost.com/drug-approval/avion-pharmaceuticals-announces-usfda-approval-of-dhivy-11267
- https://www.drugs.com/pro/dhivy.html
