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ceftolozane sulfate; tazobactam sodium · Cubist Pharms Llc · NDA 206829

Zerbaxa

Earliest generic entry, as listed
14 Feb 2036

Blocked by patent: US 10125149 (pediatric extension).

Listed patents · 12 unexpired

56 Orange Book listing rows for 12 patents, including 12 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 10125149drug product14 Feb 2036
US 10125149 listing rowdrug product14 Aug 2035
US 10125149 listing rowpediatric extension · sets the listed date14 Feb 2036
US 10376496use U-2610, U-2611, U-4548, U-45499 Mar 2035
US 10376496 listing rowuse U-26109 Sep 2034
US 10376496 listing rowuse U-26119 Sep 2034
US 10376496 listing rowuse U-45489 Sep 2034
US 10376496 listing rowuse U-45499 Sep 2034
US 10376496 listing rowpediatric extension9 Mar 2035
US 10933053use U-3090, U-3091, U-4544, U-45459 Mar 2035
US 10933053 listing rowuse U-30909 Sep 2034
US 10933053 listing rowuse U-30919 Sep 2034
US 10933053 listing rowuse U-45449 Sep 2034
US 10933053 listing rowuse U-45459 Sep 2034
US 10933053 listing rowpediatric extension9 Mar 2035
US 8906898drug substance, drug product28 Nov 2034
US 8906898 listing rowdrug substance, drug product28 May 2034
US 8906898 listing rowpediatric extension28 Nov 2034
US 10420841use U-1672, U-2631, U-3360, U-3361, U-4546, U-454714 Sep 2034
US 10420841 listing rowuse U-167214 Mar 2034
US 10420841 listing rowuse U-263114 Mar 2034
US 10420841 listing rowuse U-336014 Mar 2034
US 10420841 listing rowuse U-336114 Mar 2034
US 10420841 listing rowuse U-454614 Mar 2034
US 10420841 listing rowuse U-454714 Mar 2034
US 10420841 listing rowpediatric extension14 Sep 2034
US 11278622use U-3335, U-3336, U-4542, U-454314 Sep 2034
US 11278622 listing rowuse U-333514 Mar 2034
US 11278622 listing rowuse U-333614 Mar 2034
US 11278622 listing rowuse U-454214 Mar 2034
US 11278622 listing rowuse U-454314 Mar 2034
US 11278622 listing rowpediatric extension14 Sep 2034
US 8968753use U-1672, U-1673, U-3360, U-3361, U-4547, U-455014 Sep 2034
US 8968753 listing rowuse U-167214 Mar 2034
US 8968753 listing rowuse U-167314 Mar 2034
US 8968753 listing rowuse U-336014 Mar 2034
US 8968753 listing rowuse U-336114 Mar 2034
US 8968753 listing rowuse U-454714 Mar 2034
US 8968753 listing rowuse U-455014 Mar 2034
US 8968753 listing rowpediatric extension14 Sep 2034
US 9320740drug product14 Sep 2034
US 9320740 listing rowdrug product14 Mar 2034
US 9320740 listing rowpediatric extension14 Sep 2034
US 9872906drug product14 Sep 2034
US 9872906 listing rowdrug product14 Mar 2034
US 9872906 listing rowpediatric extension14 Sep 2034
US 10028963use U-2565, U-2566, U-4542, U-45437 Mar 2033
US 10028963 listing rowuse U-25657 Sep 2032
US 10028963 listing rowuse U-25667 Sep 2032
US 10028963 listing rowuse U-45427 Sep 2032
US 10028963 listing rowuse U-45437 Sep 2032
US 10028963 listing rowpediatric extension7 Mar 2033
US 9724353use U-2565, U-2566, U-4542, U-45437 Mar 2033
US 9724353 listing rowuse U-25657 Sep 2032
US 9724353 listing rowuse U-25667 Sep 2032
US 9724353 listing rowuse U-45427 Sep 2032
US 9724353 listing rowuse U-45437 Sep 2032
US 9724353 listing rowpediatric extension7 Mar 2033
US 7129232drug substance, drug product, use U-1676, U-3360, U-3361, U-36, U-4542, U-4543, U-4547, U-455015 Nov 2028
US 7129232 listing rowdrug substance, drug product, use U-167615 May 2028
US 7129232 listing rowdrug substance, drug product, use U-336015 May 2028
US 7129232 listing rowdrug substance, drug product, use U-336115 May 2028
US 7129232 listing rowdrug substance, drug product, use U-3615 May 2028
US 7129232 listing rowdrug substance, drug product, use U-454215 May 2028
US 7129232 listing rowdrug substance, drug product, use U-454315 May 2028
US 7129232 listing rowdrug substance, drug product, use U-454715 May 2028
US 7129232 listing rowdrug substance, drug product, use U-455015 May 2028
US 7129232 listing rowpediatric extension15 Nov 2028

Exclusivities · 2 unexpired

PEDpediatric (6 months added)12 Nov 2029
NPPnew patient population12 May 2029

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
206829 · 001 · RLDpowder, intravenousEQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL14 Feb 2036