Suppliers and packagers for CELONTIN

CELONTIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Parke Davis	CELONTIN	methsuximide	CAPSULE;ORAL	010596	NDA	Parke-Davis Div of Pfizer Inc	0071-0525-24	100 CAPSULE in 1 BOTTLE (0071-0525-24)	1957-02-08

Celontin (methsuximide): Who supplies it, what to buy, and what IP and regulatory constraints govern supply

Last updated: June 13, 2026

Celontin is the brand name for methsuximide, an oral anti-absence seizure medicine. Suppliers and supply-channel visibility depend on country and whether the pharmacy sources brand stock or approved generics. In the U.S., “Celontin” is supplied through the branded product market and manufacturer-labeled NDC supply chains, while generic methsuximide is supplied via FDA-approved ANDA routes where listed.

Who are the suppliers of Celontin (methsuximide) by market?

Answer: Celontin suppliers are those holding manufacturing/marketing rights for the branded product in the relevant country, and those distributing via NDC-labeled channels (U.S.) or wholesaler networks (EU/UK and other jurisdictions). For country-level supplier names, the reliable source is the FDA Orange Book (U.S.) for listed drug products and any labeler/manufacturer fields per NDC, paired with local wholesaler listings.

What “supplier” means for Celontin

• Brand manufacturer/labeler: entity that appears on the branded product label (NDC labeler in the U.S.).
• Wholesaler/distributor: channel partners that handle inventory procurement and distribution, often not the same as the labeler.
• Generic manufacturers: ANDA holders/manufacturers that produce methsuximide equivalents and compete on price and availability.

Key regulatory hook

• In the U.S., the FDA Orange Book is the primary index to identify:
  • whether a branded product is listed,
  • which NDCs are marketed,
  • and what application type covers each product listing. (Orange Book also lists patent and exclusivity status for brand/generic entries.) [FDA Orange Book]

Which companies manufacture methsuximide generics that compete with Celontin?

Answer: Competitive supply usually comes from generic methsuximide manufacturers that appear in the Orange Book under the active ingredient methsuximide. The generic competitive set is defined by:

• ANDA holders with approved bioequivalence and labeling,
• manufacturing sites tied to NDCs,
• and the ability to supply when shortages occur.

How to map the supplier set to practical procurement

For procurement and contracting, suppliers are identified through:

1. Orange Book NDC labeler records for methsuximide (branded and generic).
2. NDC product labeler on the specific dosage form/strength (Celontin is typically an oral solid).
3. Distribution availability via major wholesalers and direct-to-pharmacy programs.

What is the Orange Book status of Celontin and methsuximide generics?

Answer: Celontin’s Orange Book entry (and any active patent listings) dictates whether branded exclusivity or listed patents still constrain generic competition in the U.S. For procurement risk, the decisive items are:

• whether the branded product is still listed,
• whether related patents are expired,
• and whether any generics rely on a Paragraph IV certification history that produced litigation.

What to check on the Orange Book listing

• Drug Product: branded Celontin listing and NDCs.
• Application type: NDA (brand) vs ANDA (generics).
• Patent list: active patent numbers and expiration dates.
• Exclusivity: periods like orphan drug, pediatric exclusivity, or other statutory exclusivities, if applicable to the product’s Orange Book entry. [FDA Orange Book]

When do Celontin-related patents expire and how does that affect supply?

Answer: Patent expiration changes generic entry risk and pricing dynamics more than it changes short-term supply continuity. In practice, methsuximide has multiple supplier options once patent and exclusivity are not barriers for ANDA manufacturing.

What drives supply gaps even after IP expiry

Even when patents expire:

• manufacturing capacity constraints,
• raw material sourcing,
• batch release timelines,
• and distribution allocation during shortages can still limit availability.

What formulations and dosage strengths determine which suppliers can fill a purchase order?

Answer: Supplier eligibility is strength- and dosage-form-specific. Celontin procurement works through the NDC tied to:

• dosage strength,
• tablet/capsule type,
• packaging size.

Generic methsuximide also competes by matching:

• strength,
• dosage form (oral solid),
• and labeling.

Supply-chain implication

A supplier that can make methsuximide at one strength may not be able to supply another without separate NDC mapping and commercial inventory.

What generic entry risks exist for methsuximide if Celontin is scarce?

Answer: Generic entry risk is primarily governed by:

• whether ANDAs are already approved and marketed for the relevant dosage forms,
• whether manufacturing is active for those NDCs,
• and whether any active listed patents still affect the branded product’s ability to support exclusivity claims. In the U.S., once generic ANDAs are approved and marketed, shortage dynamics become supply-capacity rather than legal entry timing.

What patent estate issues affect Celontin’s supply in litigation cycles?

Answer: Patent estates are relevant when:

• generics are filing ANDAs with Paragraph IV certifications,
• or when brand holders seek injunctions tied to listed patents.

For supply planning, the decisive artifacts are Orange Book patent listings and any litigation-triggering Paragraph IV history.

Typical litigation-impact pathways

• Automatic statutory stays tied to Paragraph IV certifications (U.S. Hatch-Waxman framework).
• Settlement agreements that delay marketing for specific generic entrants.
• Country-specific enforcement differences for the same active ingredient.

Commercial landscape: How do Celontin and methsuximide generics compare on supply availability?

Answer: In most mature small-molecule antiepileptics, brand availability depends on:

• brand labeler distribution policies,
• and generic substitution patterns. Supply risk usually concentrates around:
• generic manufacturing throughput,
• or concentrated supplier ownership of a specific strength.

Key takeaways

• Celontin supply suppliers are defined by the brand labeler/marketing authorization holders (U.S.: Orange Book NDC labeler; other markets: local marketing authorization holders) and by generic methsuximide ANDA manufacturers where listed.
• For a procurement-grade supplier list, use the FDA Orange Book to extract NDC labelers for Celontin and methsuximide generics, then map those to available wholesaler/distributor channels.
• IP rarely blocks ongoing supply for older small-molecule products, but Orange Book patent/exclusivity status remains the compliance anchor for entry and substitution risk.

FAQs

1) What is Celontin’s active ingredient and what is it used for?
Celontin is methsuximide, used as an anti-absence seizure therapy in relevant seizure syndromes.

2) Is Celontin the same as generic methsuximide?
Celontin is a brand of methsuximide; generics contain the same active ingredient but may differ in labeling, packaging, and manufacturing sites tied to specific NDCs.

3) Where can I verify Celontin and methsuximide manufacturers in the U.S.?
Use the FDA Orange Book to retrieve the NDC listings and NDC labelers for both the brand and approved generic products.

4) Do patents affect whether generic methsuximide can be marketed in the U.S.?
Yes when Orange Book-listed patents tied to the reference listed drug still appear active; they can drive Paragraph IV and litigation dynamics that delay specific generic marketing.

5) Why might Celontin be hard to source even when patents are expired?
Supply constraints are often capacity- or distribution-related, including manufacturing throughput, batch release timing, and inventory allocation, not only IP status.

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA Approved Drug Products (Orange Book). https://www.accessdata.fda.gov/scripts/cder/daf/ (FDA Orange Book landing interface)