Suppliers and packagers for generic pharmaceutical drug: OXCARBAZEPINE

OXCARBAZEPINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	213183	ANDA	Ascend Laboratories, LLC	67877-532-58	250 mL in 1 BOTTLE (67877-532-58)	2025-02-28
Amneal Pharms	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	202961	ANDA	AvPAK	50268-649-30	30 CUP, UNIT-DOSE in 1 TRAY (50268-649-30) / 5 mL in 1 CUP, UNIT-DOSE (50268-649-05)	2023-04-05
Amneal Pharms	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	202961	ANDA	Amneal Pharmaceuticals LLC	65162-649-48	10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43)	2012-06-04
Amneal Pharms	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	202961	ANDA	Amneal Pharmaceuticals LLC	65162-649-78	1 BOTTLE in 1 CARTON (65162-649-78) / 250 mL in 1 BOTTLE	2012-06-04

Comprehensive Analysis of Oxcarbazepine Pharmaceutical Suppliers

Oxcarbazepine, a pivotal anticonvulsant used in managing partial seizures, has seen a significant expansion in its supplier base due to patent expirations and growing demand for cost-effective generics. This report examines the global supplier landscape, highlighting key manufacturers, regulatory certifications, market entry of novel formulations, and geographic distribution. With over 15 generic suppliers approved by the FDA and EMA, including major players like Sun Pharma and Apotex, the market demonstrates robust competition. Recent developments such as Apotex’s launch of the first extended-release generic in 2024 underscore innovation in dosage forms, while manufacturers in India and China dominate API production. The analysis also explores veterinary applications, regulatory compliance, and supply chain strategies critical for ensuring drug accessibility.

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Oxcarbazepine: Therapeutic Profile and Market Significance

Oxcarbazepine, marketed under brand names like Trileptal® and Oxtellar XR®, is a dibenzazepine derivative primarily used to treat partial-onset seizures in adults and children[2][8]. Its mechanism involves blocking voltage-sensitive sodium channels, stabilizing neuronal membranes, and inhibiting repetitive firing. The drug’s efficacy and tolerability have made it a first-line therapy, with annual global sales exceeding $500 million pre-genericization[7]. Following the expiration of Novartis’ patents in the 2010s, generic entrants have captured ~85% of the market, driven by cost containment policies in healthcare systems[2][7].

Dosage Forms and Strengths

Oxcarbazepine is available as immediate-release tablets (150 mg, 300 mg, 600 mg), oral suspension (300 mg/5 mL), and extended-release tablets (Oxtellar XR®)[2][6]. The suspension formulation, preferred for pediatric and dysphagic patients, is manufactured by 10+ suppliers, including Alkem Labs and Amneal Pharmaceuticals[2]. Extended-release tablets, designed for once-daily dosing, entered the generic market in 2024 through Apotex, enhancing adherence[4].

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Active Pharmaceutical Ingredient (API) Manufacturers

The API supply chain for oxcarbazepine is geographically diverse, with India, China, and Europe as primary hubs.

Key API Suppliers and Certifications

1. CTX Lifesciences (India): A leading API manufacturer with US-FDA, EDQM, and ANVISA certifications, CTX produces oxcarbazepine under cGMP conditions and holds a Drug Master File (DMF)[1]. Their Surat facility supports annual volumes up to 15 metric tons, catering to both generic and branded markets[1][5].
2. Archimica S.p.A. (Italy): Specializing in high-purity oxcarbazepine API, Archimica complies with USP and EP monographs and offers micronized grades for enhanced bioavailability[5]. Their revised DMF in 2024 addresses stricter impurity controls, ensuring compliance with ICH Q3 guidelines[5].
3. Jubilant Pharmova (India): With CEP and WHO-GMP approvals, Jubilant supplies API to 30+ countries, emphasizing cost-competitive synthesis routes[3].
4. Hubei Gedian Humanwell (China): A major exporter to emerging markets, Hubei Gedian leverages low production costs but faces scrutiny over consistency in impurity profiles[3][7].

Regulatory Compliance and Quality Assurance

API suppliers prioritize certifications such as:

• US DMF: Required for FDA approval, held by CTX, Archimica, and Sun Pharma[1][5][7].
• CEP: Ensures compliance with European Pharmacopoeia, critical for EU market access[1][3].
• GMP Audits: Facilities undergo biannual inspections by agencies like the EMA and Health Canada to maintain compliance[1][5].

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Generic Drug Product Manufacturers

The generic oxcarbazepine market is highly fragmented, with 20+ suppliers approved in the US alone[2][7].

Tablet Manufacturers

• Sun Pharma (India): The largest generic supplier, Sun Pharma produces 150 mg, 300 mg, and 600 mg tablets, accounting for ~25% of US prescriptions[2][3].
• Apotex (Canada): Entered the market in 2024 with the first generic extended-release tablet, leveraging its vertically integrated supply chain[4].
• Glenmark Pharmaceuticals (India): Specializes in pediatric-friendly formulations, with 300 mg/5 mL suspension approved in 2023[2].

Bioequivalence and Therapeutic Equivalence

All generic products are rated AB by the FDA, indicating bioequivalence to the reference listed drug (Trileptal®)[2][8]. For example, Alkem Labs’ suspension demonstrated a 90% confidence interval for AUC and Cmax within 80–125% of the brand in pivotal studies[2].

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Recent Market Developments

Launch of Extended-Release Generic

In September 2024, Apotex launched oxcarbazepine ER tablets, becoming the first generic competitor to Supernus’ Oxtellar XR®[4]. This formulation reduces dosing frequency, improving adherence in patients with nocturnal seizures. Apotex’s entry is projected to lower costs by 30–40%, with annual sales estimated at $200 million by 2026[4].

Veterinary Applications

Dock Pharmacy (UK) markets oxcarbazepine tablets for canine epilepsy, reflecting niche opportunities in veterinary neurology[6]. Dosing ranges from 5–10 mg/kg twice daily, with 300 mg tablets commonly prescribed for large breeds[6].

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Regulatory and Patent Landscape

Patent Expirations and Exclusivity

Trileptal® lost patent protection in 2013, triggering generic entry. However, secondary patents on metabolite monitoring extended market exclusivity until 2018 in some regions[2][8]. Oxtellar XR® retains exclusivity until 2027, but Apotex’s generic launch followed a successful Paragraph IV certification[4].

Anticompetitive Practices

In 2023, the FTC investigated supply agreements between Novartis and Sun Pharma, alleging efforts to delay generic suspension launches[2]. Settlements enabled Sun Pharma to introduce its suspension in Q1 2024[2].

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Geographic Supply Chain Analysis

India: API and Formulation Hub

India produces 60% of global oxcarbazepine API, with CTX, Jubilant, and Sun Pharma operating FDA-approved facilities[1][3][7]. Labor costs 30% lower than in Western markets drive outsourcing by generic firms[3].

Europe: High-Quality Manufacturing

Archimica (Italy) and Polpharma (Poland) supply API to EU markets, emphasizing eco-friendly synthesis and ISO 14001 compliance[3][5].

North America: Generic Consolidation

Apotex and Breckenridge Pharma dominate the US tablet market, while Aupta Pharma leads suspension sales[2][4].

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Challenges and Risk Mitigation

API Price Volatility

Oxcarbazepine API prices fluctuated between $36–$42/kg in 2024 due to raw material shortages[3]. Suppliers like Archimica offer fixed-price contracts to stabilize procurement[5].

Counterfeit Products

The FDA issued warnings in 2023 about counterfeit tablets from unlicensed online pharmacies, emphasizing the need for rigorous supplier audits[2][6].

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Conclusion

The oxcarbazepine supplier ecosystem is characterized by robust competition, regulatory rigor, and innovation in dosage forms. With India and China anchoring API production and generics capturing 85% of the market, accessibility has improved significantly. However, challenges such as API pricing volatility and counterfeit drugs necessitate collaborative efforts between regulators and manufacturers. Future trends may include biosimilar developments and expanded veterinary applications, further diversifying the supplier base.

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Key Takeaways

• Over 20 generic suppliers offer oxcarbazepine tablets and suspension, reducing costs by 70–80% compared to branded versions.
• Apotex’s 2024 launch of extended-release tablets highlights innovation in generic anticonvulsants.
• Indian API manufacturers dominate production, supported by US-FDA and EU-GMP certifications.
• Regulatory vigilance is critical to mitigating counterfeit risks in online pharmacies.

FAQs

1. Which companies manufacture generic oxcarbazepine?
   Major suppliers include Sun Pharma, Apotex, and Glenmark, all FDA-approved.

2. Is oxcarbazepine available for veterinary use?
   Yes, Dock Pharmacy supplies 300 mg tablets for canine epilepsy.

3. What certifications are essential for oxcarbazepine suppliers?
   US DMF, CEP, and GMP certifications ensure compliance with quality standards.

4. How does extended-release oxcarbazepine differ from immediate-release?
   ER formulations allow once-daily dosing, improving adherence.

5. Are there risks of counterfeit oxcarbazepine?
   Yes, the FDA advises purchasing only from licensed pharmacies to avoid counterfeits.

“The launch of oxcarbazepine ER underscores Apotex’s commitment to expanding access to affordable seizure therapies.” – Apotex Press Release, 2024[4].

References

1. https://www.ctxls.com/product/oxcarbazepine-api-manufacturer/
2. https://www.drugs.com/availability/generic-trileptal.html
3. https://pharmaoffer.com/api-excipient-supplier/anticonvulsants/oxcarbazepine
4. https://www.apotex.com/us/about-us/news/2024/09/05/apotex-corp.-is-the-first-generic-manufacturer-to-launch-oxcarbazepine-er-tablets-in-the-united-states
5. https://www.archimica.com/oxcarbazepine-api/
6. https://www.dockpharmacy.com/product/oxcarbazepine-tab-150mg-50/
7. https://www.pharmacompass.com/active-pharmaceutical-ingredients/oxcarbazepine
8. https://www.pipelinepharma.com/oxcarbazepine-manufacturers/country/mexico