Last updated: May 24, 2026
Eravacycline Dihydrochloride Suppliers: Who Manufactures the API and Finished Drug in Key Markets?
Eravacycline dihydrochloride (brand: Xerava) is supplied through a vertically integrated development and commercialization chain rooted in Tetraphase Pharmaceuticals’ original program and subsequent downstream manufacturing/packaging for FDA marketed product. The active pharmaceutical ingredient and drug-product supply for Xerava have been managed through contract and in-house manufacturing arrangements tied to FDA inspection and Orange Book-registered listings.
What suppliers matter commercially
- API (eravacycline) manufacture and supply: governed by FDA-approved manufacturing sites for the approved NDA and any later API change notifications.
- Finished drug product (drug substance to vial/kit filling): governed by FDA-approved fill-finish sites listed in NDA/CMC and reflected in manufacturing information for marketed product.
- Distribution and market access: importers and wholesalers authorized for U.S. supply chains tied to the label and distribution partners.
Who supplies eravacycline dihydrochloride (API and finished product) for Xerava in the US?
Answer: The market supply for eravacycline dihydrochloride in the U.S. is executed via FDA-approved manufacturing sites associated with the NDA for Xerava and the commercial supply chain used for FDA-labeled presentations.
Supplier identification sources used for definitive attribution
- FDA Orange Book: identifies approved NDA holders and associated patents, but manufacturing sites are typically reflected in NDA CMC sections rather than the patent record.
- FDA labeling (package insert): lists manufacturers/facility identifiers for the drug product (fill-finish) and sometimes references for drug substance.
- FDA inspection history (EIRs/Factory inspection listings): identifies actual manufacturing facilities operating under approved processes.
Because the question asks for “suppliers,” the only defensible supplier set is the one explicitly tied to the FDA-approved label and NDA manufacturing information for marketed Xerava presentations.
What facilities typically appear as suppliers for the marketed drug product?
For eravacycline dihydrochloride, suppliers fall into two buckets:
- Drug product manufacturer (vial fill and final packaging): the label typically names the applicant and may list the manufacturer for the drug product.
- Drug substance manufacturer (eravacycline intermediate and API): typically identified in CMC approvals and may also be referenced in label language depending on the current label revision.
Which companies manufacture eravacycline API (drug substance) for global markets?
Answer: Eravacycline API supply for markets that rely on the FDA-approved product is typically sourced from qualified API sites approved by the NDA holder and governed by technology transfer and change-control under the approved regulatory package.
Practical supplier map used in pharma diligence
- Primary API vendor: the site listed as the commercial drug substance manufacturer for the approved NDA.
- Secondary/backup API vendor(s): may exist via supplemental approvals for manufacturing process scale-up or geography diversification.
- Intermediates: eravacycline manufacturing requires multiple synthetic intermediates and API purification steps; suppliers can differ by intermediate vs API unless the process is fully controlled by one contracted manufacturer.
What is the Orange Book status of Xerava and how does that link to manufacturing suppliers?
Answer: Xerava’s Orange Book listing reflects NDA approval and patent coverage, not direct “supplier names” in a single record field. The supplier attribution requires cross-referencing the approved product labeling and NDA CMC manufacturing information.
Orange Book role in supplier selection
- Drives which NDA presentations are commercially supplied.
- Confirms whether a given manufacturer is producing a labeled presentation tied to a specific NDA and strength.
What FDA labeling lists the eravacycline dihydrochloride (Xerava) drug product manufacturer?
Answer: The drug product supplier is the entity named in the label under “Manufactured for” / “Manufacturing location” lines for the marketed strength and dosage form.
Which dosage forms matter for supplier mapping?
Xerava is supplied as a lyophilized powder for injection in vial presentations (strengths vary by labeling version). Supplier mapping must be done per labeled strength and vial configuration because fill-finish suppliers can change with packaging line approvals.
Do any biosimilar-style “substitutes” exist for eravacycline dihydrochloride that change supplier risk?
Answer: No biosimilar pathway applies. Eravacycline is a small-molecule antibiotic; competitive supply risk is driven by generic and 505(j) / 505(b)(2) chemical copy programs and Paragraph IV challenges (if and when filed), not biologics.
When could generic entry change eravacycline dihydrochloride supplier structure?
Answer: Supplier structure changes when generics are approved and enter distribution, which can occur ahead of or after patent expiration depending on litigation and settlement outcomes tied to Orange Book-listed patents.
Patent and exclusivity timing inputs required for supplier transition
- NDA exclusivity end date for the reference product
- Patent expiration dates for formulation, process, and method-of-use coverage
- Any settlement-driven “launch at risk” calendar for first ANDA filers
These timing inputs determine whether the market continues to rely on the reference label’s established supply chain or expands via approved ANDA vendors.
Which patent estates could affect supplier switching for eravacycline generics?
Answer: Supplier switching for generic products depends on which patents are cleared for design-around: formulations, manufacturing processes, and any method-of-use coverage.
What patent categories matter for supply contracts
- Process patents can block manufacturing adoption or require process redesign.
- Formulation patents can block vial configuration or reconstitution system.
- Method-of-use patents can restrict label carve-outs and require narrow labeling.
What Paragraph IV challenges and litigation affect supplier availability?
Answer: Litigation affects launch timing and can shift which ANDA applicants gain access to the market first. That directly impacts who becomes the next supply-source supplier for the drug product.
Settlement-driven supplier outcomes
A settlement can include:
- Non-launch periods
- Delayed approval-to-market windows
- Limited label commitments that delay some supply configurations
These conditions determine commercial procurement choices by wholesalers and hospital systems.
Commercial procurement: how do wholesalers source eravacycline dihydrochloride?
Answer: U.S. procurement is typically tied to distribution agreements with the label holder and authorized distributors. In practice:
- Hospital group purchasing organizations pull from the reference product distribution network.
- Specialty wholesalers maintain inventory across distribution lanes.
- After generic approval, procurement shifts to contract bids aligned to supply reliability and rebate structures.
Key Takeaways
- Supplier identification for eravacycline dihydrochloride must be grounded in FDA label and NDA manufacturing site information for the approved Xerava presentations.
- Orange Book records support patent-driven market access analysis, but do not directly list supplier companies in a single authoritative field.
- Competitive supply changes are governed by ANDA/generic approvals, which depend on exclusivity and patent/litigation clearance.
FAQs
- How do I determine the specific fill-finish manufacturer for Xerava vial presentations?
- Which FDA documents most reliably identify eravacycline API drug substance manufacturing sites?
- What factors determine whether an ANDA can use the same eravacycline manufacturing process as Xerava?
- How do patent settlements typically affect launch timing for eravacycline dihydrochloride generics?
- Do hospital formularies source eravacycline through wholesalers or direct distribution, and how does that change with generic entry?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Labeling for Xerava (eravacycline) prescribing information.
- U.S. Food and Drug Administration. FDA drug approval package and CMC manufacturing information for NDA approval of Xerava (eravacycline).
