cosyntropin: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amphastar Pharms Inc	CORTROSYN	cosyntropin	INJECTABLE;INJECTION	016750	NDA	Henry Schein, Inc.	0404-9839-99	1 VIAL in 1 BAG (0404-9839-99) / 1 mL in 1 VIAL	2022-01-09
Amphastar Pharms Inc	CORTROSYN	cosyntropin	INJECTABLE;INJECTION	016750	NDA	Amphastar Pharmaceuticals, Inc.	0548-5900-00	10 VIAL in 1 CARTON (0548-5900-00) / 1 mL in 1 VIAL	2003-08-01
Amphastar Pharms Inc	CORTROSYN	cosyntropin	INJECTABLE;INJECTION	016750	NDA	Medical Purchasing Solutions, LLC	71872-7318-1	1 VIAL in 1 BAG (71872-7318-1) / 1 mL in 1 VIAL	2003-08-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 29, 2026

COSYNTROPIN Suppliers (Manufacturers) and Key Sourcing Footprint for Corticotropin Therapy

Cosyntropin (synthetic ACTH 1–24) is supplied in the US and other markets primarily as the branded injectable product Cortrosyn (Cosyntropin for Injection). Current supplier decisions for cosyntropin hinge on (1) who controls the branded sterile manufacturing supply chain, (2) whether authorized generics or multiple NDA holders list on the FDA Orange Book, and (3) availability of contract sterile manufacturing (CSM) capacity for lyophilized or solution formats.

This report summarizes cosyntropin supply positioning, what to check for procurement and continuity planning, and how supplier risk maps to regulatory listings.

Who are the main suppliers of cosyntropin (Cortrosyn) in the US?

The dominant commercial supplier in the US is the holder of Cortrosyn and its distribution channels. Cosyntropin is not widely characterized by a fragmented generic shelf the way many small-molecule injectables are, so procurement typically concentrates on the NDA holder’s manufacturing network and the distribution footprint of that label.

US branded supply: what matters for procurement

Label name and strength: Cortrosyn (cosyntropin) injectable.
Dosage form: typically supplied as a sterile preparation for IV/IM ACTH stimulation testing.
Supply-continuity drivers:
- sterile fill-finish capacity for low-volume niche injectables
- lyophilization capability (if applicable to the marketed form)
- cold-chain needs for finished product (varies by label handling)
- batch release lead times and hold points (sterility/bioburden, particulate)

Actionable supplier due diligence checklist (for sourcing)

Procurement teams typically confirm:

which NDA and label holder is on the packaging (direct seller vs trading partner)
whether product is manufactured by the label holder or through CSM partners
historical NDC availability by week (to flag allocation patterns early)
FDA postmarketing inspection history for the manufacturing sites tied to the product

How many cosyntropin manufacturers are listed in the FDA Orange Book, and what does that imply for competition?

For injectable products like cosyntropin, the Orange Book typically clarifies the number of approved drug product applicants tied to specific NDCs. Procurement and market-entry strategy both depend on:

the count of NDA holders with approved listings
whether multiple NDCs are approved under the same label and whether they represent different manufacturing sites
whether any approved ANDA competitors exist for the same dosage form and route

Orange Book structure relevant to supplier mapping

When Orange Book entries exist for cosyntropin products:

Each listing is tied to an NDC.
Manufacturing site ownership can differ from label holder ownership.
Patent listings can indicate whether generic entry is being actively constrained.

What generic cosyntropin suppliers exist, and what generic entry risks are common?

Generic cosyntropin competition is often limited by:

small-volume demand economics
sterile manufacturing complexity
long validation timelines for fill-finish and container closure systems
risk of shortages if a limited number of sterile facilities support the product

Common entry constraints for injectable ACTH products

sterile processing and aseptic validation requirements
lyophilized product stability and reconstitution validation
bridging clinical data strategy depends on regulatory pathway (historically for injectables it may rely on reference product quality and bioequivalence concepts, but sterile injectables still require robust comparability)

Which Paragraph IV challenges target cosyntropin, and who has the litigation risk?

Paragraph IV filings are the main indicator of generic launch pressure. For cosyntropin, supplier strategy should check whether:

any ANDA applicants have filed Paragraph IV certifications against listed patents
any litigation has been triggered under Hatch-Waxman

What to look for in dockets affecting supplier availability

early motions and stays that delay generic approval
settlement terms that control launch timing and market share
injunction scope if the case implicates a specific dosage form or strength

What patent estate protects cosyntropin products, and how strong is it for supply continuity?

Cosyntropin’s patent estate (when present in the Orange Book) affects:

the timing of generic approvals
the stability of the branded supplier’s market position
the likelihood of delayed launches due to litigation or settlement

How supplier continuity ties to exclusivity

Supplier continuity is most threatened when:

exclusive patent coverage drops
multiple ANDAs approach readiness within the same window
a small number of CSM facilities become bottlenecked

What formulations of cosyntropin are protected and how does that change supplier options?

Even within the same active ingredient, different product forms can be treated as distinct for regulatory and manufacturing purposes:

strength differences
route (IV vs IM)
lyophilized vs solution presentations
device or container closure system changes

Supplier choices tighten when:

a competitor only has coverage for a different presentation
procurement needs a specific NDC for a hospital formulary and the label changes create substitution barriers

What is the FDA regulatory status of cosyntropin suppliers and which pathway is used?

Cosyntropin is an approved injectable medicine used for ACTH stimulation tests. Supplier eligibility to sell in the US generally depends on:

FDA approval status (NDA)
whether a corresponding ANDA exists
whether any biosimilar pathway is involved (not applicable because cosyntropin is a chemically synthesized peptide, not a biologic)
NDC-level availability and labeling compliance

Practical regulatory supplier signals

NDC discontinuations or temporary shortages
label revisions that affect handling instructions
manufacturing site changes that require FDA supplements and can trigger supply interruptions

How do cosyntropin suppliers handle sterile manufacturing constraints and quality oversight?

Sterile injectables concentrate operational risk in:

aseptic processing lines
sterilizing filtration or sterilization validation, depending on final formulation
container closure integrity testing
ongoing process verification for sterility assurance

Quality and inspection risk that can affect supply

Supplier disruptions commonly follow:

warning letters or consent decrees impacting manufacturing sites
remediation timelines for data integrity, sterility assurance, or environmental monitoring
raw material supply constraints (peptide synthesis intermediates, excipients, sterile fill components)

When does cosyntropin lose exclusivity, and when could a new supplier enter?

Exclusivity loss timing depends on:

brand exclusivities (if any)
patent term expirations for listed Orange Book patents
any patent litigation or settlement triggers controlling entry

How to map the “new supplier entry window”

Supplier entry windows are typically narrower than patent expiration dates because:

ANDA approvals require time for inspection and validation
postapproval manufacturing tech transfer can take multiple quarters
supply ramp requires confirmed CMO/CSM capacity

Which companies are challenging cosyntropin with generic applications?

Generic challengers are identified by:

ANDA submissions
Paragraph IV certifications
patent litigation that follows

Litigation-driven supplier landscape

When litigation exists, it can:

cap launch timing
drive “launch at risk” only for certain NDCs
affect whether a generic supplier remains in market or exits after adverse rulings

Commercial comparison: how does cosyntropin supplier availability differ across markets?

Supplier diversity often differs by geography because:

regulatory approval and GMP site distribution vary
procurement systems set substitution rules
national tendering can shift suppliers rapidly if allocation occurs

Cross-border supply considerations

local labeling requirements for ACTH stimulation testing
customs and logistics lead time for sterile products
availability of local wholesalers during shortage events

What generic entry risks exist for cosyntropin in hospital formularies?

Hospital switching is constrained by:

NDC-specific formularies
shortage substitution policies that prefer “same manufacturer, same NDC” during shortages
clinician preference for specific preparation and administration instructions
pharmacy procurement rules for sterile products

Operational risks

reconstitution time differences
compatibility with IV pumps and flush protocols
procurement contract terms that lock in NDC continuity

Key Takeaways

Cosyntropin sourcing in the US is centered on the branded NDA holder for Cortrosyn, with limited visible generic supplier fragmentation compared with broader injectable markets.
Supplier selection risk is driven by sterile manufacturing capacity constraints, FDA-inspection-related manufacturing downtime, and NDC-level availability rather than only patent status.
Procurement and continuity planning should map supplier risk at the NDC and manufacturing-site level, then cross-check Orange Book listings for whether additional approved suppliers exist.
Generic and Paragraph IV-driven supplier expansion depends on Orange Book patent expirations and any settlement or litigation that constrains launch timing.

FAQs

How do I identify the actual cosyntropin supplier behind a distributor listing?
Check the NDC label holder, the manufacturer name on the carton, and the FDA listing tied to that NDC.
Are there multiple cosyntropin NDCs that represent different manufacturing sites?
Yes, NDC-level listings can differ by strength, presentation, or manufacturing site even under the same label holder.
Can cosyntropin shortages occur without patent expiration?
Yes, sterile manufacturing downtime, raw material shortages for peptide/excipients, or inspection/remediation can drive shortages independent of exclusivity.
Does cosyntropin have biosimilar competitors?
No. Cosyntropin is a synthetic peptide product; biosimilar frameworks do not apply in the same way as for monoclonal antibodies or other biologics.
What supplier events should hospitals monitor during ACTH stimulation testing shortages?
NDC availability changes, FDA shortage notifications, and label/manufacturing-site updates that affect substitution rules.

References

FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
FDA Drug Shortages Database. US Food and Drug Administration.

Suppliers and packagers for generic pharmaceutical drug: cosyntropin

cosyntropin