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Orange Book drug · Brand (NDA)

Treanda

Bendamustine Hydrochloride

RLDNDA 022249 4 strengths Cephalon
Approved
Mar 20, 2008
Strengths
4
Listed patents
18

What does the FDA Orange Book show for Treanda?

Treanda contains Bendamustine Hydrochloride and is the new drug FDA Orange Book record for NDA 022249. The application has 4 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 022249

New drug application identity from the Orange Book snapshot.

Application holder
Cephalon Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
4

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription and Discontinued

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
AP

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
18

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001100MG/VIALPOWDERINTRAVENOUSPrescriptionAP
RLDRS
00225MG/VIALPOWDERINTRAVENOUSPrescriptionAP
RLDRS
00345MG/0.5ML (90MG/ML)SOLUTIONINTRAVENOUSDiscontinuedNone posted
RLD
004180MG/2ML (90MG/ML)SOLUTIONINTRAVENOUSDiscontinuedNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Cephalon Inc

The Orange Book identifies this organization as the applicant responsible for NDA 022249.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

Status varies by presentation: 2 prescription and 2 on the Discontinued Drug Product List

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

Therapeutic equivalence

TE code AP across rated presentations

An AP code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group. 2 presentations in the application have no posted TE code.

Patent & exclusivity record

12 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Apr 26, 2031. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

8 other ANDAs and 7 other NDAs found

4 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 022249 appears in 2 comparison cohorts. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-022249

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

4 approved presentations · NDA 022249
TE APRLDRS
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    18 yr 7 mo ago

  2. Patent 8609863 expires

    Listed drug product patent expiration.

    7 mo ago

  3. Patent 8791270 expires

    Listed drug product patent expiration.

    7 mo ago

  4. Patent 8895756 expires

    Listed drug product patent expiration.

    7 mo ago

  5. Patent 8609863*PED expires

    Listed listed patent expiration.

    14 d ago

  6. Patent 8791270*PED expires

    Listed listed patent expiration.

    14 d ago

  7. Patent 8895756*PED expires

    Listed listed patent expiration.

    14 d ago

  8. Today

  9. Patent 8445524 expires

    Listed drug substance patent expiration.

    in 2 yr 8 mo

  10. Patent 8669279 expires

    Listed drug product patent expiration.

    in 2 yr 8 mo

  11. Patent 8883836 expires

    Listed drug product patent expiration.

    in 2 yr 8 mo

  12. Patent 9533955 expires

    Listed drug product patent expiration.

    in 2 yr 8 mo

  13. Patent 9533955 expires

    Listed drug product patent expiration.

    in 2 yr 8 mo

  14. Patent 8445524*PED expires

    Listed listed patent expiration.

    in 3 yr 3 mo

  15. Patent 8669279*PED expires

    Listed listed patent expiration.

    in 3 yr 3 mo

  16. Patent 8883836*PED expires

    Listed listed patent expiration.

    in 3 yr 3 mo

  17. Patent 9533955*PED expires

    Listed listed patent expiration.

    in 3 yr 3 mo

  18. Patent 8436190 expires

    Listed drug product patent expiration.

    in 4 yr 4 mo

  19. Patent 8436190*PED expires

    Listed listed patent expiration.

    in 4 yr 10 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032TodayPatent 8609863: 2026-01-12Patent 8609863Patent 8791270: 2026-01-12Patent 8791270Patent 8895756: 2026-01-12Patent 8895756Patent 8609863*PED: 2026-07-12Patent 8609863*PEDPatent 8791270*PED: 2026-07-12Patent 8791270*PEDPatent 8895756*PED: 2026-07-12Patent 8895756*PEDPatent 8445524: 2029-03-26Patent 8445524Patent 8669279: 2029-03-26Patent 8669279Patent 8883836: 2029-03-26Patent 8883836Patent 9533955: 2029-03-26Patent 9533955Patent 9533955: 2029-03-26Patent 9533955Patent 8445524*PED: 2029-09-26Patent 8445524*PEDPatent 8669279*PED: 2029-09-26Patent 8669279*PEDPatent 8883836*PED: 2029-09-26Patent 8883836*PEDPatent 9533955*PED: 2029-09-26Patent 9533955*PEDPatent 8436190: 2030-10-26Patent 8436190Patent 8436190*PED: 2031-04-26Patent 8436190*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BENDAMUSTINE HYDROCHLORIDE

Strength

100MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

AP

Application

NDA 022249

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
86098637 mo ago
Product
87912707 mo ago
ProductU-1542
88957567 mo ago
Product
8609863*PED14 d ago
8791270*PED14 d ago
8895756*PED14 d ago
8445524in 2 yr 8 mo
SubstanceProductU-1402
8669279in 2 yr 8 mo
ProductU-1402
8883836in 2 yr 8 mo
ProductU-1402
9533955in 2 yr 8 mo
ProductU-1952
9533955in 2 yr 8 mo
ProductU-1949
8445524*PEDin 3 yr 3 mo
8669279*PEDin 3 yr 3 mo
8883836*PEDin 3 yr 3 mo
9533955*PEDin 3 yr 3 mo
8436190in 4 yr 4 mo
Product
8436190*PEDin 4 yr 10 mo

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Bendamustine Hydrochloride family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Treanda: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 022249 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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