Suppliers and packagers for frova

frova

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006	NDA	Endo USA, Inc.	0603-3718-34	1 BLISTER PACK in 1 CARTON (0603-3718-34) / 9 TABLET, FILM COATED in 1 BLISTER PACK	2015-10-05
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006	NDA	Endo USA, Inc.	63481-025-09	1 BLISTER PACK in 1 CARTON (63481-025-09) / 9 TABLET, FILM COATED in 1 BLISTER PACK	2001-11-08

Suppliers for the Pharmaceutical Drug: FROVA

Last updated: July 29, 2025

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Introduction

FROVA, a brand name for the medication elitriptan, is a prescription drug primarily used for the acute treatment of migraine attacks with or without aura. As a triptan class drug, FROVA (elitriptan) functions as a selective serotonin receptor agonist, providing rapid relief from migraine symptoms. Due to its clinical significance, understanding the suppliers of FROVA is crucial for stakeholders across pharmaceutical distribution, healthcare providers, and regulatory agencies.

Manufacturers of FROVA

FROVA was originally developed and marketed by Ajinomoto Pharma after gaining approval from regulatory authorities such as the US Food and Drug Administration (FDA). The primary manufacturer of FROVA has historically been Ajinomoto Pharma Co., Ltd., a subsidiary of Ajinomoto Co., Inc., based in Japan. The company specializes in the development, manufacturing, and marketing of pharmaceutical products, with a focus on neurology and pain management.

Ajinomoto Pharma’s Role:
Ajinomoto Pharma is the sole manufacturer of FROVA. As of recent years, it has maintained manufacturing facilities in Japan with international distribution channels, ensuring adherence to Good Manufacturing Practices (GMP). The company's control over production parameters ensures product consistency and regulatory compliance globally.

Distribution Channels and Global Supply

While Ajinomoto Pharma is the central entity, the distribution network for FROVA involves several regional distributors and wholesalers to ensure availability across markets:

• United States: The drug is marketed through authorized specialty pharmacies and hospital pharmacies. Details of distribution partners are typically limited due to commercial confidentiality.
• Europe and Asia: Ajinomoto and its authorized distributors handle regional distribution, complying with regional regulatory requirements (e.g., EMA approvals in Europe).

Generic Alternatives and Biosimilars

Although FROVA itself is a branded product, alternative therapies within the triptan class are produced by various suppliers. Generic versions of similar triptans, such as sumatriptan and rizatriptan, are available from multiple pharmaceutical companies, widening options for healthcare providers and patients.

However, no generic elitriptan (FROVA's active ingredient) has been widely approved or marketed globally, primarily due to patent protections and limited development of biosimilar products specific to elitriptan.

Supply Chain Considerations

• Patent Status: FROVA received patent protection in multiple jurisdictions, which restricted generic manufacturing until patent expiry or patent challenges.
• Manufacturing Capacity: Ajinomoto Pharma’s manufacturing capacity plays a crucial role in meeting global demand; supply disruptions can significantly impact availability.
• Regulatory Approvals: Regulatory requirements influence supply routes, with approval from agencies such as the FDA, EMA, and PMDA (Japan) necessary for market entry.

Key Challenges in FROVA Supply

• Limited Manufacturers: Being primarily produced by Ajinomoto Pharma limits competition, which can affect pricing and supply stability.
• Regulatory Hurdles: International regulatory variations complicate rapid global distribution.
• Patent Lifespan: The expiration of patents opens opportunities for generic manufacturers, potentially increasing supply channels in the future.

Future Outlook

As patent protections expire, the pharmaceutical landscape for elitriptan may evolve, allowing multiple manufacturers to produce generic versions, thereby increasing supply and reducing costs. Additionally, ongoing research into migraine therapeutics could introduce alternative agents affecting demand and supply dynamics for FROVA.

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Key Takeaways

• Primary Supplier: Ajinomoto Pharma Co., Ltd. remains the sole manufacturer of FROVA globally.
• Distribution: Distribution is managed via regional partners and authorized pharmacies, with regional regulatory bodies overseeing market approvals.
• Market Dynamics: Patent protections currently limit generic alternatives; future patent expirations could alter supply chains significantly.
• Supply Risks: Manufacturing capacity, regulatory hurdles, and patent protections are critical factors influencing FROVA supply stability.
• Strategic Considerations: Stakeholders should monitor patent statuses and potential new entrants to anticipate changes in supply affordability and availability.

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FAQs

1. Who manufactures FROVA?
FROVA is manufactured by Ajinomoto Pharma Co., Ltd., a Japanese pharmaceutical company specializing in neurology medications.

2. Are there generic versions of FROVA available?
Currently, generic versions of elitriptan are not widely available due to patent protections. Patients typically rely on the branded product.

3. How is FROVA distributed globally?
Distribution involves regional partners and authorized pharmacies, adhering to local regulatory approvals established by agencies such as the FDA and EMA.

4. What factors could impact future supply of FROVA?
Patent expiry, manufacturing capacity, regional regulatory changes, and entry of generic competitors could influence future supply.

5. Can other triptan medications serve as substitutes for FROVA?
Yes, other triptans like sumatriptan, rizatriptan, and naratriptan are available from multiple manufacturers and can serve as alternatives.

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Sources

1. Ajinomoto Pharma Co., Ltd. Official Website. (2022). Product Information: FROVA (elitriptan).
2. U.S. Food and Drug Administration. (2019). FROVA – FDA Drug Approval Records.
3. European Medicines Agency (EMA). (2021). Summary of Product Characteristics for triptan medications.
4. Patent and Trademark Office Databases. (2022). Patent status for elitriptan.
5. Industry Reports. (2022). Global Supply Chain of Migraine Medications.

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