AVYCAZ (Ceftazidime and Avibactam) Patent Litigation
AVYCAZ is a combination antibacterial drug consisting of ceftazidime and avibactam. Ceftazidime is a third-generation cephalosporin that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). Avibactam is a non-beta-lactam beta-lactamase inhibitor that protects ceftazidime from degradation by beta-lactamases produced by resistant bacteria, including certain extended-spectrum beta-lactamases (ESBLs) and carbapenemases. This combination enhances efficacy against resistant gram-negative bacteria. AVYCAZ was first approved by the FDA in February 2015 for indications including complicated intra-abdominal infections, urinary tract infections, and hospital-acquired pneumonia. The patents in question protect the specific molecular combination, its formulations, and methods of use. Allegations of infringement arise when generic manufacturers produce products that fall within the scope of these patent claims without authorization.
2
Pending actions
2
Total actions filed
Active
Status
02/06/2025
Established
Filing deadline
The general statute of limitations for patent infringement claims in the U.S. is six years from the date the infringement occurred. Damages can only be recovered for infringements within this six-year window prior to filing the lawsuit. Specific court-ordered filing deadlines for MDL-3134 are not yet publicly detailed in the available dockets, but the case was transferred to the District of New Jersey in February 2025, initiating active pretrial proceedings.
Who qualifies
In the context of MDL-3134, qualifying criteria for a plaintiff (in this case, the patent holder AbbVie Inc.) to assert infringement against generic manufacturers are based on the claims of the asserted patents. These patents (U.S. Patent Nos. 8,471,025; 8,835,455; 8,969,566; 9,284,314; and 9,695,122) cover specific crystalline forms, processes for preparing heterocyclic compounds, and salts related to the active ingredients of AVYCAZ. Infringement occurs if a generic manufacturer's Abbreviated New Drug Application (ANDA) product or manufacturing process falls within the scope of these patent claims. The specific claims asserted would detail the exact composition of matter, formulation, or method of use that is alleged to be copied or used without authorization. For example, claims related to specific crystalline forms of the active pharmaceutical ingredient or specific synthetic pathways used in manufacturing would define the infringing activity.
Products involved
- AVYCAZ (Ceftazidime and Avibactam)
Bellwether trials
MDL-3134 is in active litigation. While specific bellwether trial schedules have not been publicly detailed, the case was transferred to the District of New Jersey and assigned to Judge Zahid N. Quraishi in February 2025, indicating ongoing pretrial proceedings. There are no recent verdicts or trial results publicly available as the litigation is ongoing.
Settlement landscape
There are no publicly disclosed settlement estimates or average case values for MDL-3134. The litigation is ongoing, and no verdicts or settlements have been reported. A separate MDL concerning generic drug pricing settled for $200 million in early 2026, but this is not directly related to the AVYCAZ patent litigation.
Lead counsel
- Walsh Pizzi O'Reilly Falanga LLP
This page is generated from the official JPML pending-MDL report and public court records, refreshed monthly. It is provided for attorney reference and is not legal advice.
