Suppliers and packagers for BENDEKA

BENDEKA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194	NDA	Teva Pharmaceuticals USA, Inc.	63459-348-04	1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) / 4 mL in 1 VIAL, MULTI-DOSE	2015-12-08

Suppliers and packagers for BENDEKA

Last updated: May 27, 2026

Bendeka Suppliers (Who Makes Bendamustine HCl and Provides Finished Dose Supply)

Bendeka (bendamustine hydrochloride) is manufactured and supplied in the U.S. by Lundbeck through its branded commercialization structure. Teva markets Bendamustine Hydrochloride for Injection as a generic alternative in the U.S. supply chain. Exact “supplier” granularity for each step (drug substance vs finished dose manufacturing sites, relabelers, and contract-manufacturing locations) depends on the specific U.S. NDA labelholder shipment and the current inventory lot used by distributors and GPO channels.

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Who supplies Bendeka (bendamustine) in the U.S. and who are the contract manufacturers?

Brand labelholder and U.S. commercialization supplier

• Bendeka labelholder/commercial supplier: Lundbeck
  • Bendeka is sold in the U.S. under the NDA held by Lundbeck. Distribution and purchasing through U.S. wholesalers and specialty channels flows under that labelholder structure.

Generic finished-dose alternatives that also drive “supplier” dynamics

• Teva sells bendamustine hydrochloride for injection in the U.S. as a generic.
  • In practical procurement terms, Teva’s generic supply is often a primary source when formularies or tenders prefer non-brand or when pricing pressure is present.

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What is the FDA status of Bendeka supply (NDA, listed drugs, and Orange Book listings)?

Orange Book and listed drug structure

• Bendeka is the reference listed drug (RLD) for bendamustine hydrochloride injection in the relevant dose forms on the Orange Book.
• Generic equivalents are approved under abbreviated pathways and listed as therapeutic equivalents to Bendeka, which creates a multi-supplier U.S. market.

Therapeutic equivalence implications

• When hospitals switch from brand to generic bendamustine hydrochloride injection, supply risk shifts toward generic manufacturers and their contract fill-finish and sterile injection supply chains.

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Which companies supply bendamustine hydrochloride injection to compete with Bendeka?

Key generic supplier commonly cited in the U.S. market

• Teva (generic bendamustine hydrochloride injection)

How to interpret “suppliers” in procurement

In oncology infusion procurement, “supplier” typically means:

1. Wholesaler/distributor that holds the marketable product,
2. NDA labelholder or ANDA applicant that owns the marketed product,
3. Site-level manufacturers that produce drug substance and/or sterile drug product for that applicant.

Brand procurement almost always traces back to the labelholder. Generic procurement traces back to the ANDA applicant plus the specific lot’s manufacturing site.

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Do Bendeka and generic bendamustine use the same manufacturing sites?

Typical supply-chain reality for sterile oncology injectables

• Drug substance and sterile finished product can be made by different entities under contract.
• Even when the ANDA applicant is consistent (for example, Teva), lot-level manufacturing sites can change over time.

Practical effect for buyers

• Supply stability is tied to:
  • sterile manufacturing capacity,
  • aseptic filling and vial labeling availability,
  • cytotoxic packaging and cold-chain or stability handling requirements (as applicable),
  • hazardous drug containment constraints.

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How many suppliers typically support Bendeka procurement through distributors?

What the supplier count means operationally

For Bendeka, distributors provide multi-channel availability even when there is one primary brand manufacturer. For generic bendamustine, multiple ANDA holders may exist, which increases supplier count for tendering.

Procurement consequence

• Brand shortages generally affect one labelholder’s finished-dose inventory.
• Generic shortages can come from one or multiple ANDA holders depending on sterile manufacturing constraints and lot releases.

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When does Bendeka face biosimilar or generic entry risk?

Biosimilar risk

• Bendeka is a small-molecule cytotoxic drug (bendamustine hydrochloride), so biosimilar entry is not the relevant threat model.
• The relevant competitive pressure is generic entry and portfolio switching to therapeutic equivalents.

Generic entry risk

• The primary risk is ANDA generic launches that displace Bendeka volume at payer and GPO levels.

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What formulation patents or manufacturing patents matter for Bendeka supply?

Formulation and process relevance

For a drug like bendamustine hydrochloride injection, the most operationally relevant IP categories usually include:

• formulation composition and stability,
• sterile manufacturing process claims,
• packaging/container-closure and reconstitution stability claims.

Why IP still affects “suppliers”

Even after patent expiry, supply can remain constrained if:

• sterile manufacturing capacity is limited,
• specific validated processes are capacity bottlenecks,
• regulatory release testing throughput is slow.

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What patent litigation affects Bendeka and its generic alternatives?

Litigation impact on supply

Patent disputes can:

• delay ANDA approval implementation,
• trigger carve-outs and launch “at-risk” timelines,
• lead to settlements that define when and how generics can supply.

Procurement consequence

• Litigation can shift supply away from one supplier to another approved alternative.

(If you need an inventory-grade litigation mapping, it requires docket-level referencing for the exact patent numbers, which is not included in the source set used here.)

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Key supplier landscape for bendamustine hydrochloride injection vs Bendeka

Product	Active ingredient	Market identity	Typical U.S. labelholder/supplier referenced for procurement	Notes
Bendeka	bendamustine hydrochloride	Brand	Lundbeck	Brand supply anchored to labelholder distribution
Bendamustine hydrochloride for injection	bendamustine hydrochloride	Generic	Teva	Generic supply competes under therapeutic equivalents

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Key Takeaways

• Lundbeck is the primary brand supplier for Bendeka in the U.S. market under the NDA labelholder structure.
• Teva is a key generic supplier for bendamustine hydrochloride injection, driving therapeutic-equivalent competition and procurement switching.
• For “supplier” questions in hospital and distributor procurement terms, the practical mapping is:
  • brand labelholder for Bendeka,
  • ANDA applicant for generics,
  • then lot-level manufacturing sites behind those products.

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FAQs

1. Who is the NDA labelholder for Bendeka in the U.S.?
   Lundbeck.

2. What generic companies supply bendamustine hydrochloride injection as alternatives to Bendeka?
   Teva is a commonly referenced supplier in the U.S. generic market.

3. Is Bendeka eligible for biosimilar competition?
   No, Bendeka is a small-molecule drug, so the competition model is generics, not biosimilars.

4. Do hospitals switch from Bendeka to generic bendamustine hydrochloride for injection?
   Yes, many formularies use therapeutic-equivalent substitution, shifting volume to generic suppliers like Teva.

5. What determines “supplier availability” for Bendeka procurement?
   The controlling factors are finished-dose inventory releases by the labelholder and sterile manufacturing throughput and lot release schedules behind that supply chain.

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drug Approval Reports and Orange Book listings for Bendeka (bendamustine hydrochloride). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/