TOPAMAX SPRINKLE: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Pharms	TOPAMAX SPRINKLE	topiramate	CAPSULE;ORAL	020844	NDA	Janssen Pharmaceuticals, Inc.	50458-645-65	60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65)	1998-11-01
Janssen Pharms	TOPAMAX SPRINKLE	topiramate	CAPSULE;ORAL	020844	NDA	Janssen Pharmaceuticals, Inc.	50458-647-65	60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-647-65)	1998-11-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Topamax Sprinkle (generic name: topiramate) is a widely prescribed anticonvulsant and mood-stabilizing drug used for epilepsy, migraine prophylaxis, and off-label psychiatric indications. Its specialized formulation—designed to be sprinkled onto food—targets pediatric and adult populations who have difficulty swallowing traditional tablets. As demand for flexible administration grows, a detailed understanding of the suppliers providing Topamax Sprinkle is critical for stakeholders including healthcare providers, pharmaceutical distributors, and investors.

This analysis profiles key suppliers involved in the manufacturing, distribution, and licensing of Topamax Sprinkle, and evaluates their market positioning, regulatory landscape, and strategic implications.

Manufacturers of Topamax Sprinkle

1. Janssen Pharmaceuticals (A Johnson & Johnson Company)

Janssen Pharmaceuticals holds the original patent rights and manufacturing license for Topamax Sprinkle. The company developed the formulation, incorporating specific delivery mechanisms suitable for sprinkling over food or liquids. Janssen, a global leader in neurological therapeutics, maintains strict compliance with regulatory standards enforced by the FDA, EMA, and other agencies.

Manufacturing Footprint:
Janssen operates manufacturing facilities across the U.S., Europe, and Asia, ensuring a robust global supply chain. The company’s integration of R&D and manufacturing capacity allows for the scalability of Topamax Sprinkle, particularly in response to market demand fluctuations.

Regulatory Status:
Approved by multiple regulatory agencies, the patent protections and manufacturing licenses grant Janssen exclusive rights until patent expiry or patent challenges. Post-patent, generic manufacturers can enter the market, but Janssen continues to dominate through patent extensions, exclusivity periods, and strategic patent filings.

2. Generic Manufacturers

Following patent expiry, multiple generic companies have entered the market, producing bioequivalent formulations of topiramate, including sprinkle formulations. These suppliers serve to reduce costs and increase accessibility.

a. Teva Pharmaceuticals

One of the largest global generic drug manufacturers, Teva has established a significant presence in topiramate production, including sprinkle formulations.

Supply Chain & Distribution:
Teva’s extensive distribution network covers North America, Europe, and select Asian markets—making them a primary supplier for hospitals and pharmacies.
Regulatory Approvals:
Teva's generic topiramate has received FDA ANDA approval, with similar clearances from European regulators, affirming bioequivalence and compliance.

b. Mylan (now part of Viatris)

Viatris, formed from Mylan’s merger with Pfizer’s Upjohn division, provides cost-effective alternatives for Topamax Sprinkle.

Market Position:
Viatris leverages a broad manufacturing infrastructure, ensuring supply stability and competitive pricing.
Regulatory Status:
Viatris’s generic topiramate formulations have achieved global approvals, including pivotal labeling for sprinkle variants, aligned with Janssen’s formulations.

c. Sun Pharmaceutical Industries

India’s Sun Pharma produces generic topiramate, including sprinkle formulations, targeting emerging markets.

Global Reach:
Sun Pharma’s ability to supply formulations in various pack sizes and price points supports a wide patient base.
Regulatory Compliance:
Their formulations meet international standards, approved via FDA and other agency filings.

Licensing and Partnerships

In addition to independent manufacturing, strategic licensing agreements influence the supply landscape.

Janssen’s Licensing Strategy:
Janssen licenses manufacturing rights to multiple generic firms post-patent expiration. These licensing deals facilitate wide access while allowing Janssen to maintain patent protections on specific formulations or delivery mechanisms.
Distribution Alliances:
Global pharma distributors such as McKesson, Cardinal Health, and AmerisourceBergen act as critical intermediaries, ensuring the distribution of Topamax Sprinkle across healthcare settings.

Supply Chain Considerations and Market Dynamics

Regulatory Impacts

The strict regulatory environment for pharmaceuticals impacts supplier operations. Patent protections uphold Janssen's exclusivity, while regulatory approvals for generics depend on demonstrating bioequivalence and manufacturing quality. The transition from brand to generic availability typically leads to market price reductions, influencing supplier strategies.

Quality and Consistency

Suppliers maintaining high-quality standards—ISO certifications, cGMP compliance—ensure consistent product quality. This is especially crucial for sprinkle formulations, which demand precise dosing and stability.

Market Trends

Expanding Pediatric Use:
Growing pediatric prescriptions demand reliable sprinkling formulations, encouraging suppliers to develop and maintain supply lines.
Emerging Markets:
Generic manufacturers from India and China are increasingly integral, expanding accessibility and impacting global supply dynamics.

Key Considerations for Stakeholders

Medical Providers and Pharmacists:
Must verify supplier authenticity and formulation compliance to ensure safety.
Distributors:
Require robust supply chain management to prevent shortages, especially during patent transitions.
Investors:
Should monitor patent expirations, licensing agreements, and regulatory approvals, which substantially influence the supplier landscape.

Key Takeaways

Market Dominance and Supply:
Janssen Pharmaceuticals remains the primary provider of the proprietary Topamax Sprinkle formulation, leveraging its patent protections and manufacturing capacity.
Post-Patent Competition:
Generic manufacturers such as Teva, Viatris, and Sun Pharma have established substantial supply lines through bioequivalent formulations, often produced under license from original patent holders or independently.
Regulatory Framework:
Compliance with global regulatory agencies ensures supply stability, with generic approval processes facilitating market entry post-patent expiry.
Global Supply Chain:
Manufacturing diversification across regions—especially in India and Europe—drives availability and pricing dynamics in both developed and emerging markets.
Distribution and Market Expansion:
Strategic distribution partnerships and licensing agreements crucially support product reach, especially in pediatric and outpatient settings.

FAQs

1. Who is the primary manufacturer of Topamax Sprinkle in the U.S.?
Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, is the original manufacturer of Topamax Sprinkle, holding patents and exclusive rights until patent expiration or challenges.

2. Are generic versions of Topamax Sprinkle available, and who produces them?
Yes. Key generic manufacturers include Teva Pharmaceuticals, Viatris (formerly Mylan), and Sun Pharmaceutical Industries, all producing bioequivalent sprinkle formulations post-patent expiry.

3. What regulatory approvals are needed for suppliers to distribute Topamax Sprinkle internationally?
Manufacturers must obtain approvals from respective authorities such as the FDA (U.S.), EMA (Europe), and other national agencies, demonstrating bioequivalence, manufacturing quality, and safety.

4. How do licensing agreements impact the supply of Topamax Sprinkle?
Licensing enables generic firms to produce and distribute formulations under approved patents or biosimilar pathways, expanding supply options and reducing prices.

5. What factors should healthcare providers consider when sourcing Topamax Sprinkle?
Providers should verify supplier licensing, formulation compatibility, manufacturing compliance, and product stability to ensure optimal patient safety and therapeutic efficacy.

References

[1] Johnson & Johnson. (2022). Topamax (topiramate) Product Information.
[2] FDA ANDA Approvals for Topiramate: Bioequivalence and Safety Data.
[3] Teva Pharmaceuticals. (2023). Bioequivalent Topiramate Formulations.
[4] Viatris Corporate Reports. (2023). Generic Topiramate Market Data.
[5] Sun Pharmaceutical Industries. (2022). Global Generic Compliance and Distribution.

Suppliers and packagers for TOPAMAX SPRINKLE