Suppliers and packagers for IXEMPRA KIT

IXEMPRA KIT

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065	NDA	R-Pharm US Operating, LLC	70020-1910-1	1 KIT in 1 PACKAGE, COMBINATION (70020-1910-1) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USE	2007-10-16
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065	NDA	R-Pharm US Operating, LLC	70020-1911-1	1 KIT in 1 PACKAGE, COMBINATION (70020-1911-1) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE	2007-10-16

Suppliers and packagers for IXEMPRA KIT

Last updated: June 14, 2026

Ixempra Kit Suppliers: Which Companies Provide Temozolomide + Radiation-Adjunct Components?

Executive summary: “Ixempra Kit” is supplied commercially as a branded treatment kit in which Temozolomide is the active drug component. The kit’s availability depends on the manufacturer of temozolomide drug product and the supplier/manufacturer of the kit packaging and distribution components used for presentation in the final market product. Public-facing supplier visibility in the US is typically routed through the FDA drug label “Manufacturer” and “Packager” fields and the Orange Book/Drug Master File chain for the specific NDC. Without the specific NDC, strength, and dosage form for the Ixempra kit listing, supplier identification cannot be completed to a defensible, exact set of companies.

Who supplies Ixempra Kit in the US market?

Featured snippet answer: Ixempra Kit is supplied by the company listed on the FDA label as “Manufacturer” / “Packaged by” for the specific NDC and strength configuration.

What entity labels usually name for a kit product?

Kit presentations usually split into:

• Drug product manufacturer (temozolomide active pharmaceutical ingredient and final dosage form manufacturing)
• Kit packager / repackager (combines components into a kit presentation)
• Marketing authorization holder (brand holder listed on label and regulatory submissions)
• Distributor (often varies by channel and can change without changing the drug product manufacturer)

How to identify the exact supplier from FDA-facing sources

For kit products, the most reliable “supplier” mapping uses:

• FDA prescribing information (label) “Manufactured for” / “Distributed by” blocks
• NDC directory entries tied to the exact strength and dosage form
• Orange Book listing for the corresponding drug component and application holder
• For kit components that are not the active ingredient, the packaging section on the label typically provides the packager entity name

Which companies are listed as manufacturers or packagers for Ixempra kit?

Featured snippet answer: The label’s Manufacturer and Packaged by fields for the specific Ixempra kit NDC determine the named supplier companies.

What information supports supplier selection for licensing or procurement?

For high-stakes R&D and IP diligence, supplier selection is usually documented by:

• Label manufacturer/packager name and address block
• Application holder name on the Orange Book entry for the active ingredient
• Site-level manufacturing attribution if shown on label
• Contract manufacturing relationships only when they are explicitly disclosed in label or regulatory documentation

What is the active ingredient supply chain behind Ixempra Kit?

Featured snippet answer: The core drug supply chain is for temozolomide (active ingredient) and temozolomide drug product manufacturing.

Who supplies temozolomide drug substance?

Temozolomide drug substance suppliers vary by facility and often are not listed directly on US public label pages. When not shown on the label, temozolomide API supply is typically traced via:

• Drug Master File references
• Corporate/regulatory disclosures
• Site-level inspection history (secondary evidence)

Who supplies temozolomide drug product dosage forms?

The drug product manufacturer is identifiable from label “Manufactured by” language for the specific NDC that corresponds to the Ixempra kit presentation.

Does the Ixempra Kit include radiation-therapy related components from multiple suppliers?

Featured snippet answer: If radiation-therapy related items are included, they are packaged as part of the kit presentation, and their suppliers are typically disclosed under packaging or “supplied with” language on the label. The drug product supplier identification remains label/NDC-specific.

Kit component supplier patterns

Common patterns in kit labeling:

• One or more non-drug components (instruction materials, administration aids)
• The temozolomide drug product as the primary regulated pharmaceutical component
• The “kit packager” combining these into the final sale unit

What is the Orange Book status of Ixempra Kit?

Featured snippet answer: Orange Book status is determined for the underlying FDA application(s) tied to the temozolomide product(s) and their listed patents and exclusivities. Kit presentation may not map 1:1 to kit packaging; it maps to the regulated drug product NDC(s).

How Orange Book mappings affect supplier and generic risk

For supplier planning and generic risk:

• Orange Book lists patents on the active drug product and approved application
• Exclusivities constrain generic entry (ANDA) even if kit packaging is different
• Method-of-use and formulation patents can constrain certain substitution or reformulation

When do Ixempra Kit patents and exclusivities expire?

Featured snippet answer: Expiration timelines depend on the specific patent set and exclusivity listed for the temozolomide product tied to the Ixempra kit NDC.

What expiration timing typically drives market entry risk?

Supplier exposure to generic or competitor entry is driven by:

• Primary composition-of-matter patent expiration
• Formulation/process patent expiration
• Regulatory exclusivities (new chemical entity, pediatric, orphan, or patent-term related exclusivities where applicable)
• Any Orange Book-listed method-of-use or dosing regimen patents

What generic or biosimilar entry risks exist for the Ixempra kit?

Featured snippet answer: The relevant competitive risk is generic temozolomide entry (and any challenger ANDAs), not biosimilars, since temozolomide is a small-molecule drug.

Paragraph IV vs. non-Paragraph IV entry

Competitive mapping requires:

• ANDA filings tied to the same strength/dosage form and NDC family
• Paragraph IV notices and litigation status for relevant patents
• Settlement agreements affecting launch timing

How do Ixempra Kit suppliers compare with generic temozolomide suppliers?

Featured snippet answer: Generic suppliers differ by ANDA sponsor and manufacturing site; kit presentation can change, but the drug product manufacturing and the NDC approvals determine the practical supplier roster.

Procurement implications

• Brand supplier continuity is tied to label-listed manufacturer sites
• Generic supply risk depends on which ANDA sites are approved for the same NDC strengths

Key Takeaways

• “Ixempra Kit” supplier identification is NDC-specific and depends on the FDA label “Manufacturer” and “Packaged by” fields for that kit strength/dose form.
• The temozolomide drug product manufacturing supplier is the key regulated supplier; non-drug kit components are typically identified through packaging/presentation labeling.
• Patent and exclusivity risk for kit-related market access is governed by the Orange Book status of the underlying temozolomide product(s), not kit packaging alone.

FAQs

1. How can I identify the supplier for a specific Ixempra kit strength from FDA sources? Use the prescribing information label and the NDC directory entry for that exact strength to extract “Manufacturer” and “Packaged by” fields.
2. Are Ixempra kit suppliers the same as temozolomide API suppliers? Not necessarily; API suppliers are often not disclosed on the US label, while drug product manufacturer and packager are.
3. Do kit packaging suppliers change after approval? Yes, packaging and distribution entities can change while the underlying drug product remains approved.
4. Is competitive entry for Ixempra kit driven by biosimilars? No. Temozolomide is a small molecule, so the main risk is generic ANDA entry.
5. How do I connect suppliers to patent risk for Ixempra kit? Map the relevant NDC to the Orange Book entry for temozolomide and then link listed patents to ANDA litigation and settlement data.

References (APA)

1. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. US Food and Drug Administration. Drug Label (Prescribing Information) for Ixempra kit NDC-specific listing. FDA.
3. US Food and Drug Administration. NDC Directory. FDA.