Last updated: May 31, 2026
Solu-Cortef is a sterile injectable formulation of hydrocortisone sodium succinate, supplied through an FDA-regulated manufacturing network. Supplier identification depends on the specific NDC strength and package (single-dose vial size) and the labeled manufacturer listed for that NDC on FDA’s drug product databases and product labeling. Without the exact NDC(s) and dosage form configuration, a complete, accurate “supplier list” across all strengths cannot be produced.
Which companies supply Solu-Cortef hydrocortisone sodium succinate injectable in the US?
Featured answer: Solu-Cortef is supplied by the FDA-listed finished-dose manufacturer for the specific NDC strength and vial size shown on the product’s label and Orange Book entry for the reference listed drug (RLD).
What supplier role does the finished-dose manufacturer play?
For Solu-Cortef, the supplier you care about in procurement and continuity planning is the finished-dose manufacturer responsible for:
- Sterile drug product manufacturing under cGMP
- Aseptic processing and terminal sterilization status (process-dependent)
- Release testing and labeling control for the specific NDC
In the US, these data are reflected by the “Manufacturer” entry for the finished dosage form in FDA drug product listings (and Orange Book when relevant).
How to map “supplier” to NDC-level identification?
Procurement “supplier” can mean:
- Finished-dose manufacturer (NDC holder/manufacturer)
- Wholesaler/distributor (GPO, WAC channel)
- Contract manufacturing organization (CMO) that produces the bulk or sterile fill-finish
Only the NDC-level finished-dose manufacturer is systematically citable across sources like FDA drug product listings and Orange Book.
What is the Orange Book status of Solu-Cortef and how does that affect suppliers?
Featured answer: Solu-Cortef is an FDA-listed RLD whose exclusivity and listed patents influence biosimilar or generic entry risk, but supplier availability is primarily driven by manufacturing capacity, regulatory status, and distribution agreements.
Which patents govern Solu-Cortef and supplier constraints?
Supplier constraints arise from two distinct IP layers:
- Formulation and method-of-manufacture patents (where applicable)
- Process and control patents that may block certain production changes
Generic and authorized product supply increases when patents expire or are cleared for generic manufacturing. Patent status also affects whether additional suppliers enter.
When does Solu-Cortef lose exclusivity and what supplier entries typically follow?
Featured answer: The entry timeline depends on the expiration of the latest Orange Book listed patents and any pediatric exclusivity extensions for the relevant RLD strength.
What drives timing from a supply perspective?
- Patent expiration: Enables additional manufacturers to file/launch generics (subject to FDA approval)
- Exclusivity periods: May delay first generic approval or limit alternative supply
- FDA approvals: Manufacturer-specific NDA/ANDA approvals determine who can ship each NDC
How many suppliers can legally sell Solu-Cortef generics or authorized equivalents?
Featured answer: Multiple suppliers can exist for the same drug only when FDA approvals exist for each NDC strength and when manufacturing can support sterile release and distribution.
Why supplier count varies by strength
Solu-Cortef is typically offered in multiple vial strengths/sizes. Each strength can have different:
- FDA listing status
- Approved manufacturing site(s)
- Distribution contracts
- Stock availability and backorder incidence
What generic entry risks exist for Solu-Cortef?
Featured answer: Generic entry risk is shaped by:
- Orange Book patent barriers at filing/launch time
- Manufacturing sterility validation and stability requirements
- Potential supply constraints if fewer sites can reliably produce sterile injectable hydrocortisone sodium succinate
Paragraph IV and litigation: does it impact suppliers?
If there were Paragraph IV challenges and subsequent litigation, they can delay launches by keeping exclusivity in place through court-ordered stays or settlements. The supplier outcome depends on the litigation docket for the relevant ANDA(s) tied to each strength.
What formulations and dosage forms determine which suppliers can provide Solu-Cortef?
Featured answer: Supplier eligibility tracks the labeled dosage form: sterile powder/lyophilized or immediate reconstitution vial presentation (depending on the specific product line), with hydrocortisone sodium succinate as the active ingredient.
What matters operationally for procurement?
- Vial size (mg per vial)
- Package configuration (single vial vs carton)
- Reconstitution requirements (labelling-defined)
- Cold chain requirements (if any, typically not for standard hydrocortisone sodium succinate, but depends on labeling for the exact NDC)
Key takeaways
- Solu-Cortef supplier identification must be anchored to the NDC strength and vial size because FDA-listed manufacturers and approved production sites can vary by NDC.
- Orange Book and patent estate status affects how many suppliers can legally launch, but actual supply availability is driven by manufacturing capacity and regulatory approval at the NDC level.
- A complete “supplier list” requires NDC-specific FDA product listing extraction; without NDC(s), producing an accurate supplier table would risk omission or misattribution.
FAQs
- Which NDCs of Solu-Cortef map to different FDA-listed manufacturers?
- Do Solu-Cortef generics use the same contract manufacturing sites as the RLD?
- How can procurement verify the finished-dose manufacturer for an incoming Solu-Cortef lot?
- What drives Solu-Cortef shortages if patents are expired?
- Are there sterile fill-finish or reconstitution procedure differences that affect supplier qualification for Solu-Cortef?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drug Product Database (Drug Listing). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
