Assyro AI

Orange Book product · Brand (NDA)

ZERBAXA

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

Brand (NDA)NDA 206829RX CUBIST PHARMS LLC
View CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM familyOpen on FDA Orange Book

At a glance

Dec 19, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

38

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 19, 2014

    11 yr 8 mo ago

  2. Today

  3. Patent 7129232 expires

    Listed drug substance patent expiration.

    May 15, 2028

    in 1 yr 11 mo

  4. Patent 7129232 expires

    Listed drug substance patent expiration.

    May 15, 2028

    in 1 yr 11 mo

  5. Patent 7129232 expires

    Listed drug substance patent expiration.

    May 15, 2028

    in 1 yr 11 mo

  6. Patent 7129232 expires

    Listed drug substance patent expiration.

    May 15, 2028

    in 1 yr 11 mo

  7. Patent 7129232*PED expires

    Listed listed patent expiration.

    Nov 15, 2028

    in 2 yr 5 mo

  8. Patent 10028963 expires

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

    Sep 07, 2032

    in 6 yr 4 mo

  9. Patent 10028963 expires

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

    Sep 07, 2032

    in 6 yr 4 mo

  10. Patent 9724353 expires

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

    Sep 07, 2032

    in 6 yr 4 mo

  11. Patent 9724353 expires

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

    Sep 07, 2032

    in 6 yr 4 mo

  12. Patent 10028963*PED expires

    Listed listed patent expiration.

    Mar 07, 2033

    in 6 yr 10 mo

  13. Patent 9724353*PED expires

    Listed listed patent expiration.

    Mar 07, 2033

    in 6 yr 10 mo

  14. Patent 10420841 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  15. Patent 10420841 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  16. Patent 10420841 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  17. Patent 10420841 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  18. Patent 11278622 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  19. Patent 11278622 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  20. Patent 8968753 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  21. Patent 8968753 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  22. Patent 8968753 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  23. Patent 8968753 expires

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

    Mar 14, 2034

    in 7 yr 10 mo

  24. Patent 9320740 expires

    Listed drug product patent expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  25. Patent 9872906 expires

    Listed drug product patent expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  26. Patent 8906898 expires

    Listed drug substance patent expiration.

    May 28, 2034

    in 8 yr 1 mo

  27. Patent 10376496 expires

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

    Sep 09, 2034

    in 8 yr 4 mo

  28. Patent 10376496 expires

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

    Sep 09, 2034

    in 8 yr 4 mo

  29. Patent 10933053 expires

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

    Sep 09, 2034

    in 8 yr 4 mo

  30. Patent 10933053 expires

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

    Sep 09, 2034

    in 8 yr 4 mo

  31. Patent 10420841*PED expires

    Listed listed patent expiration.

    Sep 14, 2034

    in 8 yr 4 mo

  32. Patent 11278622*PED expires

    Listed listed patent expiration.

    Sep 14, 2034

    in 8 yr 4 mo

  33. Patent 8968753*PED expires

    Listed listed patent expiration.

    Sep 14, 2034

    in 8 yr 4 mo

  34. Patent 9320740*PED expires

    Listed listed patent expiration.

    Sep 14, 2034

    in 8 yr 4 mo

  35. Patent 9872906*PED expires

    Listed listed patent expiration.

    Sep 14, 2034

    in 8 yr 4 mo

  36. Patent 8906898*PED expires

    Listed listed patent expiration.

    Nov 28, 2034

    in 8 yr 7 mo

  37. Patent 10376496*PED expires

    Listed listed patent expiration.

    Mar 09, 2035

    in 8 yr 10 mo

  38. Patent 10933053*PED expires

    Listed listed patent expiration.

    Mar 09, 2035

    in 8 yr 10 mo

  39. Patent 10125149 expires

    Listed drug product patent expiration.

    Aug 14, 2035

    in 9 yr 3 mo

  40. Patent 10125149*PED expires

    Listed listed patent expiration.

    Feb 14, 2036

    in 9 yr 10 mo

Pharmaceutical detail

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

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Listed patents (38)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7129232May 15, 2028in 1 yr 11 mo
SubstanceProductU-36
7129232May 15, 2028in 1 yr 11 mo
SubstanceProductU-1676
7129232May 15, 2028in 1 yr 11 mo
SubstanceProductU-3361
7129232May 15, 2028in 1 yr 11 mo
SubstanceProductU-3360
7129232*PEDNov 15, 2028in 2 yr 5 mo
10028963Sep 07, 2032in 6 yr 4 mo
U-2566
10028963Sep 07, 2032in 6 yr 4 mo
U-2565
9724353Sep 07, 2032in 6 yr 4 mo
U-2565
9724353Sep 07, 2032in 6 yr 4 mo
U-2566
10028963*PEDMar 07, 2033in 6 yr 10 mo
9724353*PEDMar 07, 2033in 6 yr 10 mo
10420841Mar 14, 2034in 7 yr 10 mo
U-2631
10420841Mar 14, 2034in 7 yr 10 mo
U-1672
10420841Mar 14, 2034in 7 yr 10 mo
U-3361
10420841Mar 14, 2034in 7 yr 10 mo
U-3360
11278622Mar 14, 2034in 7 yr 10 mo
U-3335
11278622Mar 14, 2034in 7 yr 10 mo
U-3336
8968753Mar 14, 2034in 7 yr 10 mo
U-1673
8968753Mar 14, 2034in 7 yr 10 mo
U-1672
8968753Mar 14, 2034in 7 yr 10 mo
U-3361
8968753Mar 14, 2034in 7 yr 10 mo
U-3360
9320740Mar 14, 2034in 7 yr 10 mo
Product
9872906Mar 14, 2034in 7 yr 10 mo
Product
8906898May 28, 2034in 8 yr 1 mo
SubstanceProduct
10376496Sep 09, 2034in 8 yr 4 mo
U-2611
10376496Sep 09, 2034in 8 yr 4 mo
U-2610
10933053Sep 09, 2034in 8 yr 4 mo
U-3091
10933053Sep 09, 2034in 8 yr 4 mo
U-3090
10420841*PEDSep 14, 2034in 8 yr 4 mo
11278622*PEDSep 14, 2034in 8 yr 4 mo
8968753*PEDSep 14, 2034in 8 yr 4 mo
9320740*PEDSep 14, 2034in 8 yr 4 mo
9872906*PEDSep 14, 2034in 8 yr 4 mo
8906898*PEDNov 28, 2034in 8 yr 7 mo
10376496*PEDMar 09, 2035in 8 yr 10 mo
10933053*PEDMar 09, 2035in 8 yr 10 mo
10125149Aug 14, 2035in 9 yr 3 mo
Product
10125149*PEDFeb 14, 2036in 9 yr 10 mo
Agent CTA Background

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