Last updated: May 25, 2026
HYSINGLA ER Suppliers: Who Manufactures, Supplies, and Distributes Hydrocodone Bitartrate ER?
Executive summary: HYSINGLA ER (hydrocodone bitartrate extended-release) is marketed in the US under AbbVie’s brand. The key “supplier” categories for diligence are (1) the FDA-labeled manufacturer/MAH on the US label, (2) the API and excipient sourcing chain for the ER dosage form, and (3) distributors used to reach pharmacies, hospitals, and wholesalers. Without the exact FDA label/manufacturer block and Orange Book listing entries, a complete and accurate supplier map cannot be produced.
What companies supply HYSINGLA ER in the US (labeler of record, manufacturer, distributor)?
Featured snippet answer: The supplier set for HYSINGLA ER is anchored by the company listed on the FDA-approved prescribing information as the manufacturer/labeler and any listed US distributors. A defensible supplier list requires the product label’s “Manufactured for” / “Distributed by” / “Manufacturing site” entries and the FDA Orange Book labeler-to-product link.
Who is the labeler/MAH for HYSINGLA ER?
- HYSINGLA ER is marketed by AbbVie in the US under brand ownership.
What do “supplier” classifications include for an ER opioid?
- Finished-dose manufacturer: site(s) that manufacture the ER tablets.
- API source: hydrocodone bitartrate API supplier chain (not routinely identified on the public label).
- Excipients and ER matrix components: suppliers of release-controlling polymers and tableting grades.
- Distribution layer: NDA holder supply to wholesalers, group purchasing organizations (GPOs), and specialty channels.
Which firms supply hydrocodone bitartrate extended-release tablets (API and dosage-form supply chain)?
Featured snippet answer: Hydrocodone bitartrate ER tablet supply chains are typically multi-tier. Public disclosures usually identify the drug product manufacturer rather than the API supplier in a way that supports a full “who supplies the API” list.
API supply chain diligence targets
- API manufacturer listed in regulatory filings or DMFs (where accessible).
- Compatibility of hydrocodone bitartrate with ER matrix and coating process.
- Control strategy for impurity profiles (impurities and residual solvents).
ER dosage-form supply chain diligence targets
- Release profile control via polymer matrix and tablet coating system.
- Compression and coating subcontracting (common in ER lines).
- Packaging supplier for tamper-resistant features (where specified in label).
How do Orange Book listings identify HYSINGLA ER suppliers (labeler, patents, and product identifiers)?
Featured snippet answer: Orange Book provides the labeler name and links to formulation/method-of-use patents for the specific drug product strength and dosage form. It does not reliably enumerate API or excipient suppliers.
What Orange Book fields should be pulled for supplier mapping
- Labeler name associated with the listed drug.
- Dosage form and strength identifiers.
- Patent list tied to each listed drug (helps infer technology scope used by the product manufacturer).
What formulations are protected for HYSINGLA ER, and how does formulation tie to supplier selection?
Featured snippet answer: Formulation and manufacturing-process patents typically constrain permissible excipients, release mechanisms, and manufacturing conditions, which in turn narrows the set of qualified contract manufacturers (CMOs) and excipient vendors that can replicate the product.
Formulation and manufacturing-process categories that influence suppliers
- ER matrix composition and particle-size specs
- Granulation method and tablet compression controls
- Coating and post-processing parameters
- Stability and impurity control specifications
Which manufacturers compete for HYSINGLA ER supply (CMOs and contract manufacturing risks)?
Featured snippet answer: Competitive supply is often driven by whether alternative manufacturers can meet opioid ER performance specs and regulatory quality systems, but publicly available “supplier-to-finished-dose” competition signals usually require label manufacturer-site entries or inspection records.
Risk points for sourcing an ER opioid
- FDA inspection outcomes for relevant sites
- Ability to match dissolution profile and abuse-deterrent requirements (where applicable)
- Scale-up capability for ER tablet processes
When could supplier substitution become available (commercial timing and regulatory constraints)?
Featured snippet answer: Supplier substitution timing depends on regulatory approvals for site changes and any linked patent and regulatory exclusivity status for the specific drug product.
Site-change pathways
- NDA supplement approvals for manufacturing site changes
- CMC comparability requirements for ER dissolution and impurity control
What generic entry risks affect the supply base for HYSINGLA ER?
Featured snippet answer: Generic entry risks for HYSINGLA ER depend on patent and exclusivity status. If exclusivity/patents are active, supply typically remains with the listed drug’s established manufacturing network.
Paragraph IV and litigation-driven impacts
- Paragraph IV filings and associated litigation can delay market share shift to generics.
- Settlement terms can lock in supply dynamics via launch timing.
How strong is the patent estate for HYSINGLA ER, and does that constrain supply?
Featured snippet answer: Patent estate strength does not directly determine API supplier identity, but it can constrain which manufacturers can legally supply an AB-rated generic or alternative ER formulation.
Patent types that matter for supply constraints
- Formulation and ER mechanism patents
- Method-of-manufacture patents
- Method-of-use patents (less common to drive supply, more to drive label claims)
Key Takeaways
- A reliable “suppliers for HYSINGLA ER” answer must be anchored to the FDA label’s manufacturer/distributor block and Orange Book labeler linkage.
- Publicly accessible sources generally identify the finished-dose manufacturer and labeler, not the full API/excipient supplier chain.
- Patent and CMC constraints narrow the pool of qualified manufacturers for opioid ER supply, but they do not by themselves identify named suppliers.
FAQs
- Who is the labeler/MAH for HYSINGLA ER in the Orange Book?
- Do Orange Book listings name hydrocodone bitartrate API suppliers for HYSINGLA ER?
- How do manufacturing site changes for HYSINGLA ER get approved with the FDA?
- What role do formulation patents play in blocking generic HYSINGLA ER supply?
- Can contract manufacturers produce HYSINGLA ER tablets under the NDA holder’s control without changing the labeler name?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Drug: HYSINGLA ER). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
