Suppliers and packagers for generic pharmaceutical drug: ETHOSUXIMIDE

ETHOSUXIMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bionpharma	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	040430	ANDA	Bryant Ranch Prepack	63629-8005-1	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8005-1)	2016-10-21
Bionpharma	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	040430	ANDA	Bionpharma Inc.	69452-152-20	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-152-20)	2016-10-21
Heritage Pharms Inc	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	200892	ANDA	Chartwell RX, LLC	62135-790-12	120 CAPSULE in 1 BOTTLE (62135-790-12)	2015-09-09

Ethosuximide: Who Supplies It and How the Supply Chain Typically Maps to the Patent Landscape

Last updated: April 24, 2026

What suppliers provide ethosuximide globally?

Ethosuximide is widely marketed as an established generic active pharmaceutical ingredient (API) and finished dosage form. Supplier availability is typically split across two layers:

• API manufacturers (ethosuximide as the raw pharmaceutical ingredient)
• Finished dosage form suppliers (tablets/capsules under branded or generic labels)

In practice, the supplier set varies by market due to regulatory approvals, manufacturing sites, and distribution networks. For a patent-focused assessment, the most decision-relevant supplier intelligence comes from:

• Drug Master File (DMF) holders and API producers
• ANDA/market authorization holders by country
• Importer and distributor records tied to specific strengths and dosage forms

Where can supplier identity be verified using hard regulatory artifacts?

A supplier list that is defensible for R&D or investment decisions is usually reconstructed from these sources:

• FDA Orange Book listings for finished products (applicant/holder per strength and dosage form)
  • Used to identify who holds approvals in the US for each NDA/ANDA product line. (See citations [1].)
• FDA DMF and CDER drug substance listings (where accessible via FDA systems) to trace API manufacturing authorizations by DMF holder and site.
• EU national competent authority databases and EMA-linked marketing authorization records to map MAH (marketing authorization holder) and sites.
• UK MHRA product licenses and importer/distributor records tied to specific product strengths.
• Global trade and customs catalogues are sometimes the only way to resolve “API supplier” names in countries that do not publish DMF-to-manufacturer transparency publicly.

What supplier types matter for an ethosuximide deal?

For an established molecule like ethosuximide, the supplier landscape is dominated by generic networks. Patent and freedom-to-operate (FTO) work typically focuses on the supplier side that determines manufacturing and regulatory provenance.

1) Finished dosage form manufacturers (market-facing)

These entities control:

• formulation composition and manufacturing process for tablets/capsules
• labeling, package insert language, and product-specific stability data
• the drug product that patients receive in a given geography

2) API suppliers (process and impurity profile)

These entities control:

• synthetic route variants (if multiple routes exist across approved vendors)
• impurity patterns that can affect ANDA comparability and regulatory scrutiny
• batch consistency and compliance performance

3) Contract manufacturers (CMOs)

These entities control:

• packaging, compression, blending, and quality system execution
• site-specific process controls that can create practical differentiation even when API is common

What does the US supplier footprint look like (regulatory perspective)?

In the US, ethosuximide products are listed in the FDA Orange Book with application holders and approved strengths for marketed dosage forms. The Orange Book is the primary hard registry to enumerate finished-product holders and to map the US supplier base by strength and dosage form. (See citations [1].)

Supplier mapping by patent relevance (how to structure the diligence)

A supplier list needs to be tied to patent work. Use the following mapping logic:

A) Identify product approvals tied to ethosuximide strengths

From regulatory listings (e.g., Orange Book), capture:

• product name
• applicant/holder
• dosage form and strength
• approval type and submission history indicators

B) Link holders to manufacturing and packaging sites

Then trace:

• labeler/manufacturer identity from product packaging and regulatory product listing pages
• importer/distributor data for non-US markets
• site references if available in filings

C) Link to API provenance

Trace DMF and/or supplier certification networks where available:

• API supplier names tied to DMFs
• quality agreements through audit packages (where deal teams can access them)

Where do R&D and investment teams typically land for ethosuximide sourcing?

For an older, generic CNS drug with broad availability, teams typically source through:

• multiple approved generic finished-product vendors for patient access and clinical supply
• multiple qualified API vendors to protect against batch disruption and cost swings
• CMOs experienced in oral solid dose to stabilize manufacturing timelines and fill-finish execution

How to use this for a supplier shortlist (actionable framework)

A defensible shortlist for ethosuximide typically includes:

1. Top US Orange Book holders for finished dosage forms, by strength (for market access and regulatory track record).
2. API suppliers with the most transparent regulatory pathway (DMF holders where public information exists, plus long-running GMP compliance histories in oral solid dose supply chains).
3. CMOs that can support rapid tech transfer to oral solid dose with documented analytical method transfer and impurity monitoring capability.

Key Takeaways

• Ethosuximide supplier coverage is dominated by generic networks; the credible supplier base is best enumerated through regulatory registries rather than marketing claims.
• Finished-product suppliers in each geography map to application holders in registries such as the FDA Orange Book.
• API supplier identity is typically validated via DMF linkage and regulatory filing transparency available in public or deal-access channels.
• For patent and FTO work, supplier diligence should be built as a chain of provenance: approval holder to manufacturing site to API source.

FAQs

1) Is ethosuximide primarily supplied as an API or finished dosage form?

Both. In most jurisdictions it is commercially supplied as finished oral solid dosage forms, with API sourced from multiple qualified vendors.

2) Which registry is the fastest way to identify US finished-product supplier holders?

The FDA Orange Book is the primary starting point for finished-product application holders tied to ethosuximide strengths and dosage forms.

3) Why do API supplier names matter for patent work on ethosuximide?

They can determine manufacturing route, impurity profile, and process equivalence, which affects regulatory comparability and FTO execution in practical scenarios.

4) Are there many different ethosuximide manufacturers?

Yes. Generic drugs like ethosuximide tend to have multiple approval holders and manufacturing sites across regions, producing a dense supplier base.

5) What should be captured to make supplier data “deal-ready”?

Capture regulatory holder identity, strength and dosage form, and site provenance, then map to API supplier linkage through DMF or documented quality agreements.

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References

[1] FDA. Drugs@FDA / Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (ethosuximide listings). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-04-25)