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Generic Zerbaxa Availability

Zerbaxa is a brand name of ceftolozane/tazobactam, approved by the FDA in the following formulation(s):

ZERBAXA (ceftolozane sulfate; tazobactam sodium - powder;iv (infusion))

  • Manufacturer: CUBIST PHARMS LLC
    Approval date: December 19, 2014
    Strength(s): EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL [RLD]

Has a generic version of Zerbaxa been approved?

No. There is currently no therapeutically equivalent version of Zerbaxa available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zerbaxa. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Cephem compounds
    Patent 7,129,232
    Issued: October 31, 2006
    Inventor(s): Ohki; Hidenori & Okuda; Shinya & Yamanaka; Toshio & Ohgaki; Masaru & Toda; Ayako & Kawabata; Kohji & Inoue; Satoshi & Misumi; Keiji & Itoh; Kenji & Satoh; Kenji
    Assignee(s): Astellas Pharma Inc. Wakunaga Pharmaceutical Co., Ltd
    The present invention relates to a compound of the formula [I]: wherein R1 is lower alkyl, hydroxy(lower)alkyl or halo(lower)alkyl, and R2 is hydrogen or amino protecting group, or R1 and R2 are bonded together and form lower alkylene or lower alkenylene; R3 is hydrogen or lower alkyl; R4 is R5 is carboxy or protected carboxy; and R6 is amino or protected amino, or a pharmaceutically acceptable salt thereof, a process for preparing a compound of the formula [I], and a pharmaceutical composition comprising a compound of the formula [I] in admixture with a pharmaceutically acceptable carrier.
    Patent expiration dates:
    • October 21, 2024
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      Patent use: METHODS OF TREATING BACTERIAL ILLNESSES
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      Drug substance
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      Drug product
  • Tazobactam arginine compositions
    Patent 8,476,425
    Issued: July 2, 2013
    Assignee(s): Cubist Pharmaceuticals, Inc.
    This disclosure provides compositions containing solid forms of tazobactam arginine, and methods of manufacturing and using these compositions.
    Patent expiration dates:
    • September 27, 2032
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      Drug substance
  • Tazobactam arginine compositions
    Patent 8,685,957
    Issued: April 1, 2014
    Assignee(s): Cubist Pharmaceuticals, Inc.
    This disclosure provides compositions containing solid forms of tazobactam arginine, and methods of manufacturing and using these compositions.
    Patent expiration dates:
    • September 27, 2032
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      Patent use: METHODS OF TREATING BACTERIAL ILLNESSES
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      Drug substance
  • Solid forms of ceftolozane
    Patent 8,906,898
    Issued: December 9, 2014
    Assignee(s): Calixa Therapeutics, Inc.
    Novel solid forms of ceftolozane are described, as well as methods for the preparation and use of these solid forms.
    Patent expiration dates:
    • May 28, 2034
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      Drug substance
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      Drug product
  • Ceftolozane-tazobactam pharmaceutical compositions
    Patent 8,968,753
    Issued: March 3, 2015
    Assignee(s): Calixa Therapeutics, Inc.
    Pharmaceutical compositions can include ceftolozane lyophilized in the absence of tazobactam.
    Patent expiration dates:
    • March 14, 2034
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      Patent use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS
    • March 14, 2034
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      Patent use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION
  • Ceftolozane-tazobactam pharmaceutical compositions
    Patent 9,320,740
    Issued: April 26, 2016
    Assignee(s): MERCK SHARP & DOHME CORP.
    Pharmaceutical compositions are provided in unit dosage forms comprising ceftolozane and tazobactam in separate unit dosage form containers, ceftolozane prepared in the absence of tazobactam, tazobactam prepared in the absence of ceftolozane, and/or compositions where ceftolozane and tazobactam are first combined within a unit dosage form container.
    Patent expiration dates:
    • March 14, 2034
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      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • December 19, 2019 - NEW CHEMICAL ENTITY
    • December 19, 2024 - GENERATING ANTIBIOTIC INCENTIVES NOW

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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