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Orange Book drug · Brand (NDA)

Zerbaxa

Ceftolozane Sulfate; Tazobactam Sodium

RLDNDA 206829 Cubist Pharms LLC
Approved
Dec 19, 2014
Strengths
1
Listed patents
24

What does the FDA Orange Book show for Zerbaxa?

Zerbaxa contains Ceftolozane Sulfate; Tazobactam Sodium and is the new drug FDA Orange Book record for NDA 206829. The application has 1 presentation 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 206829

New drug application identity from the Orange Book snapshot.

Application holder
Cubist Pharmaceuticals LLC

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

Product presentations
1

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

Marketing categories
Prescription

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
None posted

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

Listed patents
24

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
001EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIALPOWDERINTRAVENOUSPrescriptionNone posted
RLDRS

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

Cubist Pharmaceuticals LLC

The Orange Book identifies this organization as the applicant responsible for NDA 206829.

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

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

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

The latest future date recorded across those files is Feb 14, 2036. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 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 206829 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Powder · Intravenous

Ceftolozane Sulfate; Tazobactam Sodium

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-206829

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.

Product detail

NDA 206829
RLDRS
Strength
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr 9 mo ago

  2. Today

  3. Patent 7129232 expires

    Listed drug substance patent expiration.

    in 1 yr 10 mo

  4. Patent 7129232 expires

    Listed drug substance patent expiration.

    in 1 yr 10 mo

  5. Patent 7129232 expires

    Listed drug substance patent expiration.

    in 1 yr 10 mo

  6. Patent 7129232 expires

    Listed drug substance patent expiration.

    in 1 yr 10 mo

  7. Patent 7129232*PED expires

    Listed listed patent expiration.

    in 2 yr 4 mo

  8. Patent 10028963 expires

    Listed method-of-use patent (U-2566) expiration.

    in 6 yr 3 mo

  9. Patent 10028963 expires

    Listed method-of-use patent (U-2565) expiration.

    in 6 yr 3 mo

  10. Patent 9724353 expires

    Listed method-of-use patent (U-2565) expiration.

    in 6 yr 3 mo

  11. Patent 9724353 expires

    Listed method-of-use patent (U-2566) expiration.

    in 6 yr 3 mo

  12. Patent 10028963*PED expires

    Listed listed patent expiration.

    in 6 yr 9 mo

  13. Patent 9724353*PED expires

    Listed listed patent expiration.

    in 6 yr 9 mo

  14. Patent 10420841 expires

    Listed method-of-use patent (U-2631) expiration.

    in 7 yr 9 mo

  15. Patent 10420841 expires

    Listed method-of-use patent (U-1672) expiration.

    in 7 yr 9 mo

  16. Patent 10420841 expires

    Listed method-of-use patent (U-3361) expiration.

    in 7 yr 9 mo

  17. Patent 10420841 expires

    Listed method-of-use patent (U-3360) expiration.

    in 7 yr 9 mo

  18. Patent 11278622 expires

    Listed method-of-use patent (U-3335) expiration.

    in 7 yr 9 mo

  19. Patent 11278622 expires

    Listed method-of-use patent (U-3336) expiration.

    in 7 yr 9 mo

  20. Patent 8968753 expires

    Listed method-of-use patent (U-1673) expiration.

    in 7 yr 9 mo

  21. Patent 8968753 expires

    Listed method-of-use patent (U-1672) expiration.

    in 7 yr 9 mo

  22. Patent 8968753 expires

    Listed method-of-use patent (U-3361) expiration.

    in 7 yr 9 mo

  23. Patent 8968753 expires

    Listed method-of-use patent (U-3360) expiration.

    in 7 yr 9 mo

  24. Patent 9320740 expires

    Listed drug product patent expiration.

    in 7 yr 9 mo

  25. Patent 9872906 expires

    Listed drug product patent expiration.

    in 7 yr 9 mo

  26. Patent 8906898 expires

    Listed drug substance patent expiration.

    in 7 yr 11 mo

  27. Patent 10376496 expires

    Listed method-of-use patent (U-2611) expiration.

    in 8 yr 3 mo

  28. Patent 10376496 expires

    Listed method-of-use patent (U-2610) expiration.

    in 8 yr 3 mo

  29. Patent 10933053 expires

    Listed method-of-use patent (U-3091) expiration.

    in 8 yr 3 mo

  30. Patent 10933053 expires

    Listed method-of-use patent (U-3090) expiration.

    in 8 yr 3 mo

  31. Patent 10420841*PED expires

    Listed listed patent expiration.

    in 8 yr 3 mo

  32. Patent 11278622*PED expires

    Listed listed patent expiration.

    in 8 yr 3 mo

  33. Patent 8968753*PED expires

    Listed listed patent expiration.

    in 8 yr 3 mo

  34. Patent 9320740*PED expires

    Listed listed patent expiration.

    in 8 yr 3 mo

  35. Patent 9872906*PED expires

    Listed listed patent expiration.

    in 8 yr 3 mo

  36. Patent 8906898*PED expires

    Listed listed patent expiration.

    in 8 yr 6 mo

  37. Patent 10376496*PED expires

    Listed listed patent expiration.

    in 8 yr 9 mo

  38. Patent 10933053*PED expires

    Listed listed patent expiration.

    in 8 yr 9 mo

  39. Patent 10125149 expires

    Listed drug product patent expiration.

    in 9 yr 2 mo

  40. Patent 10125149*PED expires

    Listed listed patent expiration.

    in 9 yr 8 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036TodayPatent 7129232: 2028-05-15Patent 7129232Patent 7129232: 2028-05-15Patent 7129232Patent 7129232: 2028-05-15Patent 7129232Patent 7129232: 2028-05-15Patent 7129232Patent 7129232*PED: 2028-11-15Patent 7129232*PEDPatent 10028963: 2032-09-07Patent 10028963Patent 10028963: 2032-09-07Patent 10028963Patent 9724353: 2032-09-07Patent 9724353Patent 9724353: 2032-09-07Patent 9724353Patent 10028963*PED: 2033-03-07Patent 10028963*PEDPatent 9724353*PED: 2033-03-07Patent 9724353*PEDPatent 10420841: 2034-03-14Patent 10420841Patent 10420841: 2034-03-14Patent 10420841Patent 10420841: 2034-03-14Patent 10420841Patent 10420841: 2034-03-14Patent 10420841Patent 11278622: 2034-03-14Patent 11278622Patent 11278622: 2034-03-14Patent 11278622Patent 8968753: 2034-03-14Patent 8968753Patent 8968753: 2034-03-14Patent 8968753Patent 8968753: 2034-03-14Patent 8968753Patent 8968753: 2034-03-14Patent 8968753Patent 9320740: 2034-03-14Patent 9320740Patent 9872906: 2034-03-14Patent 9872906Patent 8906898: 2034-05-28Patent 8906898Patent 10376496: 2034-09-09Patent 10376496Patent 10376496: 2034-09-09Patent 10376496Patent 10933053: 2034-09-09Patent 10933053Patent 10933053: 2034-09-09Patent 10933053Patent 10420841*PED: 2034-09-14Patent 10420841*PEDPatent 11278622*PED: 2034-09-14Patent 11278622*PEDPatent 8968753*PED: 2034-09-14Patent 8968753*PEDPatent 9320740*PED: 2034-09-14Patent 9320740*PEDPatent 9872906*PED: 2034-09-14Patent 9872906*PEDPatent 8906898*PED: 2034-11-28Patent 8906898*PEDPatent 10376496*PED: 2035-03-09Patent 10376496*PEDPatent 10933053*PED: 2035-03-09Patent 10933053*PEDPatent 10125149: 2035-08-14Patent 10125149Patent 10125149*PED: 2036-02-14Patent 10125149*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

Strength

EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 206829

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
7129232in 1 yr 10 mo
SubstanceProductU-36
7129232in 1 yr 10 mo
SubstanceProductU-1676
7129232in 1 yr 10 mo
SubstanceProductU-3361
7129232in 1 yr 10 mo
SubstanceProductU-3360
7129232*PEDin 2 yr 4 mo
10028963in 6 yr 3 mo
U-2566
10028963in 6 yr 3 mo
U-2565
9724353in 6 yr 3 mo
U-2565
9724353in 6 yr 3 mo
U-2566
10028963*PEDin 6 yr 9 mo
9724353*PEDin 6 yr 9 mo
10420841in 7 yr 9 mo
U-2631
10420841in 7 yr 9 mo
U-1672
10420841in 7 yr 9 mo
U-3361
10420841in 7 yr 9 mo
U-3360
11278622in 7 yr 9 mo
U-3335
11278622in 7 yr 9 mo
U-3336
8968753in 7 yr 9 mo
U-1673
8968753in 7 yr 9 mo
U-1672
8968753in 7 yr 9 mo
U-3361
8968753in 7 yr 9 mo
U-3360
9320740in 7 yr 9 mo
Product
9872906in 7 yr 9 mo
Product
8906898in 7 yr 11 mo
SubstanceProduct
10376496in 8 yr 3 mo
U-2611
10376496in 8 yr 3 mo
U-2610
10933053in 8 yr 3 mo
U-3091
10933053in 8 yr 3 mo
U-3090
10420841*PEDin 8 yr 3 mo
11278622*PEDin 8 yr 3 mo
8968753*PEDin 8 yr 3 mo
9320740*PEDin 8 yr 3 mo
9872906*PEDin 8 yr 3 mo
8906898*PEDin 8 yr 6 mo
10376496*PEDin 8 yr 9 mo
10933053*PEDin 8 yr 9 mo
10125149in 9 yr 2 mo
Product
10125149*PEDin 9 yr 8 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.

No other applications share this active ingredient.

View full Ceftolozane Sulfate; Tazobactam Sodium 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.

Zerbaxa: 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 206829 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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