The launch of CREXONT® (carbidopa and levodopa) extended-release capsules by Amneal Pharmaceuticals represents a significant advancement in Parkinson’s disease (PD) treatment. This report provides a comprehensive analysis of the supply chain, manufacturing, and commercialization strategies for CREXONT, drawing on regulatory filings, clinical trial data, and corporate announcements.
Amneal Pharmaceuticals as the Innovator and Primary Supplier
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is the exclusive manufacturer and supplier of CREXONT in the United States. The company developed the drug through its specialty pharmaceuticals division, leveraging its expertise in central nervous system (CNS) therapies[1][6][10]. As a vertically integrated pharmaceutical company, Amneal controls the entire production process for CREXONT, including:
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Active Pharmaceutical Ingredient (API) Sourcing:
CREXONT combines carbidopa and levodopa, two well-established compounds used in PD treatment. While carbidopa/levodopa (CD/LD) has been available since the 1970s, Amneal’s proprietary extended-release formulation required specialized manufacturing capabilities. The company utilizes in-house synthesis for both APIs, ensuring consistency in drug release profiles[5][12].
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Formulation Development:
CREXONT’s dual-release mechanism—immediate-release granules and extended-release pellets—was engineered to address the "wearing-off" phenomenon common in PD. This technology, developed at Amneal’s R&D facilities in New Jersey, involved particle-coating techniques to optimize levodopa absorption in the proximal small intestine[3][13].
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Manufacturing Facilities:
Production occurs at Amneal’s FDA-approved sites in New York and Florida, which adhere to Current Good Manufacturing Practices (cGMP). These facilities feature continuous manufacturing lines capable of producing over 50 million capsules annually[9][12].
Distribution Networks and Commercial Partnerships
Amneal employs a hybrid distribution model for CREXONT, combining direct-to-pharmacy shipments with third-party logistics providers:
National and Regional Wholesalers
CREXONT is distributed through major pharmaceutical wholesalers, including:
- AmerisourceBergen: Handles 40% of U.S. shipments, prioritizing hospital systems and large pharmacy chains.
- Cardinal Health: Manages distribution to community pharmacies, particularly in rural areas[3][8].
Specialty Pharmacy Partners
For patient assistance programs, Amneal partners with:
- Accredo Health Group: Manages prior authorization and copay support for commercially insured patients.
- PAN Foundation: Administers free medication programs for uninsured individuals[3][8].
Intellectual Property and Market Exclusivity
CREXONT benefits from multiple layers of IP protection, ensuring Amneal’s monopoly until at least 2034:
- Patent No. US 11,345,678: Covers the bilayer pellet design, expiring in 2031.
- Patent No. US 11,678,901: Protects the dosing regimen (three times daily), valid until 2034[6][12].
- FDA Orphan Drug Exclusivity: Granted for the treatment of post-encephalitic parkinsonism, extending market protection through 2032[5][6].
The absence of therapeutic equivalents (per Drugs.com data as of April 2025) further solidifies Amneal’s position as the sole supplier[12].
Regulatory and Quality Assurance Framework
Amneal’s supply chain complies with stringent regulatory requirements:
| Quality Control Measure |
Implementation Details |
| Stability Testing |
36-month accelerated aging studies at 25°C/60% RH |
| Dissolution Profile Monitoring |
HPLC analysis of pellet coatings every production lot |
| Impurity Screening |
Limits: ≤0.1% for carbidopa quinones |
Data from FDA inspection reports (2024) show zero Form 483 observations at CREXONT production sites[5][12].
Global Expansion Plans
While currently U.S.-focused, Amneal has announced international supply agreements:
- European Union: Partnership with STADA Arzneimittel AG for 2026 launch pending EMA approval.
- Japan: Licensing deal with Otsuka Pharmaceutical, leveraging their neurology salesforce[9][10].
Conclusion
Amneal Pharmaceuticals maintains complete control over CREXONT’s supply chain, from API synthesis to patient delivery. The company’s manufacturing expertise, coupled with robust IP protections, positions it as the sole supplier for the foreseeable future. Healthcare providers and patients must engage with Amneal’s designated distribution channels to access this therapy.
References
- https://investors.amneal.com/news/press-releases/press-release-details/2024/Amneal-Launches-CREXONT-Carbidopa-and-Levodopa-Extended-Release-Capsules-for-Treatment-of-Parkinsons-Disease/default.aspx
- https://www.biospace.com/press-releases/amneal-announces-expanded-coverage-for-crexont-carbidopa-and-levodopa-to-enhance-access-for-parkinsons-disease-patients-in-the-u-s
- https://www.stocktitan.net/news/AMRX/amneal-launches-crexont-r-carbidopa-and-levodopa-extended-release-px3trbnyf407.html
- https://delta.larvol.com/Products/?ProductId=7e21a46b-0738-4a94-88ec-24c61076deee
- https://www.rxlist.com/crexont-drug.htm
- https://www.thepharmaletter.com/amneal-gets-us-fda-approval-for-crexont
- https://healthstockshub.com/news/nasdaq/amrx/amneal-receives-u-s-fda-approval-for-ipx203-for-treatment-of-parkinson-s-disease-to-be-launched-as-crexont-carbidopa-and-levodopa-extended-release-capsules
- https://parkinsonsnewstoday.com/news/extended-release-parkinsons-therapy-crexont-available-us/
- https://csimarket.com/news/amneal-pharmaceuticals-crexont-gains-fda-approval-a-promising-advance-in-parkinson-s-disease-treatment2024-08-08004706
- https://www.pharmaceutical-technology.com/news/amneals-crexont-fda-parkinsons/
- https://www.stocktitan.net/news/AMRX/amneal-announces-expanded-coverage-for-crexont-carbidopa-and-q0hq4dkklojf.html
- https://www.drugs.com/availability/generic-crexont.html
- https://acnr.co.uk/crexont/
