Suppliers and packagers for generic pharmaceutical drug: dofetilide

Dofetilide supply is concentrated in a small set of qualified manufacturers for the active pharmaceutical ingredient (API) and finished dosage forms (capsules). In the US, what matters for continuity of supply, substitution risk, and generic/authorized-entry timelines is the Orange Book listing coverage for the branded dosage strengths and the underlying FDA-registered sites that can manufacture and ship dofetilide capsules.

Which companies supply dofetilide API and finished capsules?

Bottom line: For dofetilide, the supplier pool is narrow relative to higher-volume cardiovascular drugs. Finished dofetilide capsule supply depends on which ANDA and label holders control dosage strengths and who is contracted to manufacture at FDA-registered sites.

What is dofetilide’s commercial dosage form in the US market?

• Dosage form: capsules (commonly 125 mcg and 250 mcg strengths)
• Administration context: rhythm-control use in atrial fibrillation/flutter under REMS-like prescribing controls (not a typical REMS with a distribution program, but strict initiation/monitoring protocols)

How to identify the true supplier for any dofetilide product?

For business and regulatory due diligence, the “supplier” is not just the label holder. It is the combination of:

• ANDA holder (who controls label and submissions)
• cGMP manufacturing sites for drug product
• DMF holder(s) and their API manufacturing sites (if the ANDA references a DMF or has its own API route)

In practice, contracts shift between label holders and contract manufacturing organizations (CMOs). Tracking FDA registration and application history is the fastest path to confirm current capability.

What does the Orange Book reveal about dofetilide’s market entry and supply chain?

Bottom line: The Orange Book controls what products are listed as therapeutically equivalent and where exclusivity or patents can delay entry. For supply risk and substitution planning, you need the listed strengths, dosage forms, and application numbers, then map each to manufacturing sites.

What to extract from Orange Book listings

• Drug product name and strength (capsule strength)
• Application type (NDA vs ANDA)
• Applicant/holder
• Patent and exclusivity codes tied to each listed strength
• Whether a product is “listed” versus withdrawn or discontinued

Why Orange Book coverage matters for suppliers

• If a strength is tied up by regulatory exclusivity or stays off the market, available supplier capacity is reduced.
• If multiple ANDAs exist for the same strength, supply fragmentation rises, lowering single-site dependency risk.

Which manufacturers are associated with dofetilide capsule supply in the US?

Bottom line: Without the specific FDA application and site data for current dofetilide capsule strengths, the only accurate statement is that supplier identification must be done via FDA product listing and manufacturing-site mapping, not via generic industry assumptions.

Typical evidence trail used by procurement and competitive intelligence teams

• FDA Orange Book for:
  • application numbers by strength
  • label holder names
• FDA Drugs@FDA for:
  • application details and regulatory history
• FDA list of drug establishments and facility registrations for:
  • which sites manufacture at the time of record
• DMF references (where available) to:
  • API manufacturing sites

Do dofetilide API suppliers overlap with other class antiarrhythmics?

Bottom line: API manufacturing for small-molecule cardiovascular drugs often overlaps across chemistry families, but dofetilide’s distinct structure and handling requirements make full supplier interchange less common. Procurement risk depends on whether the same DMF holder has multiple alternative manufacturing lines and redundant qualified sites.

What to check for API supply redundancy

• Multiple qualified API manufacturing sites under the same DMF or supporting documentation
• Batch size and campaign capability for API-to-drug-product turnarounds
• Evidence of shipping and storage suitability for dofetilide intermediates and final API

How do generic and authorized entrants affect dofetilide supply?

Bottom line: Any ANDA entry that is therapeutically equivalent increases the number of possible drug product suppliers. The real-world impact depends on whether each ANDA has:

• active, stable production at a registered site
• sustained commercial shipments (not just approvals)

What drives supply stability after ANDA approval

• Scale-up performance and regulatory inspections
• API availability under the referenced DMF route
• Contract manufacturing commitments and release testing throughput

What patent and litigation factors can constrain dofetilide supplier expansion?

Bottom line: Patent estates tied to branded dofetilide strengths can delay ANDA entry. When entry is delayed, available supply sources stay limited.

Where patent constraints show up operationally

• Fewer ANDAs for a given strength
• Fewer drug product lots available in each quarter
• Concentrated reliance on a small set of manufacturers

Key Takeaways

• Dofetilide supplier identification requires mapping label holders (ANDA/NDA holders) to FDA-registered manufacturing sites for the specific capsule strengths.
• Orange Book listings and corresponding FDA application records are the controlling dataset for current US supply structure.
• Supply stability is driven by the number of active ANDA products per strength and the redundancy of API manufacturing capability under referenced DMFs.

FAQs

1. How do I confirm the actual manufacturer of a specific dofetilide capsule strength sold in the US?
   Use the Orange Book listing for that strength to identify the application holder, then map to FDA-registered drug product manufacturing sites for that application.

2. Which dataset best predicts dofetilide API supply continuity for procurement planning?
   FDA DMF reference mapping and FDA facility registration history for the API manufacturing sites behind the listed product.

3. What are the most common failure points for dofetilide supply during generic ramp-ups?
   API sourcing under the referenced DMF, drug product scale-up at the registered site, and release-test throughput.

4. Can multiple suppliers reduce shortages of dofetilide capsules?
   Yes, but only if multiple ANDA products for each capsule strength are actively producing and shipping, not just approved on paper.

5. How do Orange Book patents affect dofetilide availability even when ANDAs exist?
   They can delay or narrow entry timing by strength, keeping supply constrained until patent and exclusivity barriers clear.

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm