Summary
The provided claims are primarily about pricing, distributors, discounts, shortages, generics, patents, and alternative antibiotics, none of which are supported or addressed by the provided FDA label excerpts (BOXed Warning, 1.4, 5.1, 5.2, 6.1). No on-label medical claims (indication/dosing/safety instructions) are evaluated against the label.
Category Scores
Accurate Statements
Tigecycline (brand name Tygacil) is an antibiotic for serious infections.
Only partial/indirect support: the provided excerpts do not describe indications or limitations of use beyond HAP/VAP; seriousness/indication is not stated in the supplied label text.
Unsupported Statements
Pricing for tigecycline varies by buyer volume, region, and negotiation.
Not supported by the provided FDA prescribing information excerpts.
Manufacturers and distributors like Pfizer, McKesson, or Henry Schein may provide tiered discounts for bulk hospital or pharmacy purchases.
Not supported by the provided FDA prescribing information excerpts.
Tiered bulk purchase discounts for tigecycline are typically 10-30% off list price for orders over 100-500 vials, depending on contracts.
Not supported by the provided FDA prescribing information excerpts.
Exact bulk discount terms require direct quotes and are not publicly listed.
Not supported by the provided FDA prescribing information excerpts.
Group purchasing organizations (GPOs) can provide deeper discounts for hospitals via annual bids.
Not supported by the provided FDA prescribing information excerpts.
GPO discounts for tigecycline can be up to 40% below average wholesale price (AWP).
Not supported by the provided FDA prescribing information excerpts.
For non-hospital buyers, Drugs.com or GoodRx list base prices of about $200-300 per 50 mg vial.
Not supported by the provided FDA prescribing information excerpts.
Bulk deals for tigecycline require RFQs from suppliers like Cardinal Health.
Not supported by the provided FDA prescribing information excerpts.
Approximate list price estimates per vial for tigecycline are $250-350 for 1-10 vials.
Not supported by the provided FDA prescribing information excerpts.
No bulk discount is listed for tigecycline for 1-10 vials.
Not supported by the provided FDA prescribing information excerpts.
Approximate list price estimates per vial for tigecycline are $220-300 for 50-100 vials.
Not supported by the provided FDA prescribing information excerpts.
For 50-100 vials, the bulk discount range for tigecycline is estimated to be 10-20%.
Not supported by the provided FDA prescribing information excerpts.
Approximate list price estimates per vial for tigecycline are $150-250 for 500+ vials.
Not supported by the provided FDA prescribing information excerpts.
For 500+ vials, the bulk discount range for tigecycline is estimated to be 25-40% (GPO).
Not supported by the provided FDA prescribing information excerpts.
Prices from 2023-2024 data for tigecycline may fluctuate with shortages.
Not supported by the provided FDA prescribing information excerpts.
FDA-approved generics for tigecycline from Mylan (now Viatris) and Sandoz have been available since 2020.
Not supported by the provided FDA prescribing information excerpts.
Tigecycline generics from Mylan (now Viatris) and Sandoz are stated to cut costs by 50-70% versus brand.
Not supported by the provided FDA prescribing information excerpts.
Bulk generic pricing for tigecycline starts at $80-150 per vial for large orders.
Not supported by the provided FDA prescribing information excerpts.
Steeper discounts may be available for bulk tigecycline generics.
Not supported by the provided FDA prescribing information excerpts.
DrugPatentWatch indicates no major barriers remain for competitive bidding regarding tigecycline patents.
Not supported by the provided FDA prescribing information excerpts.
Pfizer (Tygacil) is described as the primary brand source for tigecycline.
Not supported by the provided FDA prescribing information excerpts.
McKesson and AmerisourceBergen are described as distributors providing fast U.S. bulk supply of tigecycline.
Not supported by the provided FDA prescribing information excerpts.
Eravacycline (Xerava) is described as an alternative to tigecycline for similar indications.
Not supported by the provided FDA prescribing information excerpts for TYGACIL.
Meropenem is described as an alternative IV antibiotic that may provide cheaper bulk savings in similar indications.
Not supported by the provided FDA prescribing information excerpts.
Ongoing tigecycline shortages (per FDA) may inflate prices.
Not supported by the provided FDA prescribing information excerpts.
Contradictions
Important Omissions
No mention of key FDA label limitations/warnings relevant to safety: BOXED WARNING for increased all-cause mortality and that TYGACIL should be reserved for use when alternative treatments are not suitable; and that TYGACIL is not indicated for hospital-acquired or ventilator-associated pneumonia (HAP/VAP).
Importance:
High
Safety Assessment
Potential Patient Risk:
High
While the supplied claims are mostly non-clinical (pricing/distribution), the only label-relevant medical claim does not include required boxed-warning context or the specified limitation of use (not indicated for HAP/VAP). This omission could lead to misunderstanding of safety/appropriate use.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Claims largely concern pricing, contracting, distributors, and other drugs and are not supported by the provided FDA prescribing information excerpts; no FDA label safety/limitations content is accurately and completely addressed.
Suggested Improvement
Restrict claims to what is present in the provided FDA label excerpts (e.g., increased all-cause mortality; boxed warning/‘reserved’ use; not indicated for HAP/VAP) and avoid pricing/discount/distributor/general market assertions not contained in the prescribing information.