FDA Orange Book · active-ingredient family
Ceftolozane sulfate; tazobactam sodium
Ceftolozane sulfate; tazobactam sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZERBAXA · NDA 206829
1
Brand (NDA)
0
Generics (ANDA)
24
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZERBAXARLD | CUBIST PHARMS LLC | NDA 206829 | — | Dec 19, 2014 |
Listed patents (24)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7129232 | May 15, 2028 | in 1 yr 11 mo | SubstanceProductU-36 |
| 7129232*PED | Nov 15, 2028 | in 2 yr 5 mo | |
| 9724353 | Sep 07, 2032 | in 6 yr 4 mo | U-2565 |
| 10028963 | Sep 07, 2032 | in 6 yr 4 mo | U-2566 |
| 9724353*PED | Mar 07, 2033 | in 6 yr 10 mo | |
| 10028963*PED | Mar 07, 2033 | in 6 yr 10 mo | |
| 8968753 | Mar 14, 2034 | in 7 yr 10 mo | U-1673 |
| 10420841 | Mar 14, 2034 | in 7 yr 10 mo | U-2631 |
| 11278622 | Mar 14, 2034 | in 7 yr 10 mo | U-3335 |
| 9872906 | Mar 14, 2034 | in 7 yr 10 mo | Product |
| 9320740 | Mar 14, 2034 | in 7 yr 10 mo | Product |
| 8906898 | May 28, 2034 | in 8 yr 1 mo | SubstanceProduct |
| 10376496 | Sep 09, 2034 | in 8 yr 4 mo | U-2611 |
| 10933053 | Sep 09, 2034 | in 8 yr 4 mo | U-3091 |
| 8968753*PED | Sep 14, 2034 | in 8 yr 4 mo | |
| 9872906*PED | Sep 14, 2034 | in 8 yr 4 mo | |
| 9320740*PED | Sep 14, 2034 | in 8 yr 4 mo | |
| 10420841*PED | Sep 14, 2034 | in 8 yr 4 mo | |
| 11278622*PED | Sep 14, 2034 | in 8 yr 4 mo | |
| 8906898*PED | Nov 28, 2034 | in 8 yr 7 mo | |
| 10933053*PED | Mar 09, 2035 | in 8 yr 10 mo | |
| 10376496*PED | Mar 09, 2035 | in 8 yr 10 mo | |
| 10125149 | Aug 14, 2035 | in 9 yr 3 mo | Product |
| 10125149*PED | Feb 14, 2036 | in 9 yr 10 mo |
Ceftolozane sulfate; tazobactam sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
