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Generic Zyvox Availability

Zyvox is a brand name of linezolid, approved by the FDA in the following formulation(s):

ZYVOX (linezolid - for suspension;oral)

  • Manufacturer: PHARMACIA AND UPJOHN
    Approval date: April 18, 2000
    Strength(s): 100MG/5ML [RLD] [AB]

ZYVOX (linezolid - solution;iv (infusion))

  • Manufacturer: PHARMACIA AND UPJOHN
    Approval date: April 18, 2000
    Strength(s): 200MG/100ML (2MG/ML), 400MG/200ML (2MG/ML), 600MG/300ML (2MG/ML) [RLD] [AP]

ZYVOX (linezolid - tablet;oral)

  • Manufacturer: PHARMACIA AND UPJOHN
    Approval date: April 18, 2000
    Strength(s): 600MG [RLD] [AB]

Has a generic version of Zyvox been approved?

A generic version of Zyvox has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Zyvox and have been approved by the FDA:

linezolid for suspension;oral

  • Manufacturer: ROXANE
    Approval date: June 3, 2015
    Strength(s): 100MG/5ML [AB]

linezolid solution;iv (infusion)

  • Manufacturer: HOSPIRA INC
    Approval date: July 7, 2015
    Strength(s): 600MG/300ML (2MG/ML) [AP]
  • Manufacturer: TEVA PHARMS
    Approval date: June 27, 2012
    Strength(s): 600MG/300ML (2MG/ML) [AP]

linezolid tablet;oral

  • Manufacturer: TEVA PHARMS USA
    Approval date: May 18, 2015
    Strength(s): 600MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zyvox. 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.

  • Substituted oxazine and thiazine oxazolidinone antimicrobials
    Patent 5,688,792
    Issued: November 18, 1997
    Inventor(s): Barbachyn; Michael R. & Brickner; Steven J. & Hutchinson; Douglas K.
    Assignee(s): Pharmacia & Upjohn Company
    A compound of structural Formula I: ##STR1## or pharmaceutically acceptable salts thereof wherein: X is O, S, SO, SO.sub.2, SNR.sup.10 or S(O)NR.sup.10 ; R is (a) hydrogen, (b) C.sub.1 -C.sub.8 alkyl optionally substituted with one or more of the following: F, Cl, hydroxy, C.sub.1 -C.sub.8 alkoxy, C.sub.1 -C.sub.8 acyloxy or --O--CH.sub.2 --Ph, (c) C.sub.3 -C.sub.6 cycloalkyl, (d) amino, (e) C.sub.1 -C.sub.8 alkylamino, (f) C.sub.1 -C.sub.8 dialkylamino or (g) C.sub.1 -C.sub.8 alkoxy; R.sup.1 is H, except when X is O then R.sup.1 can be H, CH.sub.3, CN, CO.sub.2 H, CO.sub.2 R or (CH.sub.2).sub.m R.sup.11 (m is 1 or 2); R.sup.2 is independently H, F or Cl; R.sup.3 is H except when X is O and R.sup.1 is CH.sub.3 then R.sup.3 can be H or CH.sub.3 ; R.sup.10 is independently H, C.sub.1 -C.sub.4 alkyl (optionally substituted with chloro, fluoro, hydroxy, C.sub.1 -C.sub.8 alkoxy, amino, C.sub.1 -C.sub.8 alkylamino, or C.sub.1 -C.sub.8 dialkylamino) or p-toluenesulfonyl; R.sup.11 is hydrogen, OH, OR, OCOR, NH.sub.2, NHCOR or N(R.sup.10).sub.2 ; and n is 0, 1 or 2. The oxazine and thiazine oxazolidinone derivatives are useful antimicrobial agents, effective against a number of human and veterinary pathogens, including gram-positive aerobic bacteria such as multiply-resistant staphylococci, streptococci and enterococci as well as anaerobic organisms such as Bacteroides spp. and Clostridia spp. species, and acid-fast organisms such as Mycobacterium tuberculosis, Mycobacterium avium and Mycobacterium spp.
    Patent expiration dates:
    • November 18, 2014
      ✓ 
      Patent use: TREATMENT OF MICROBIAL INFECTIONS
      ✓ 
      Drug substance
    • November 18, 2014
      ✓ 
      Patent use: TREATMENT OF MICROBIAL INFECTIONS
    • May 18, 2015
      ✓ 
      Pediatric exclusivity
  • Oxazolidinone tablet formulation
    Patent 6,514,529
    Issued: February 4, 2003
    Inventor(s): Ken; Yamamoto & Homer; Lin
    Assignee(s): Pharmacia & Upjohn Company
    The present invention provides a compressed tablet of an antibacterial oxazolidinone agent which provides high drug load and excellent bioavailability.
    Patent expiration dates:
    • March 15, 2021
      ✓ 
      Drug product
    • September 15, 2021
      ✓ 
      Pediatric exclusivity
  • Linezolid—crystal form II
    Patent 6,559,305
    Issued: May 6, 2003
    Inventor(s): Michael S.; Bergren
    Assignee(s): Pharmacia & Upjohn Company
    The invention is a novel crystal form (Form II) of a known compound, linezolid which is useful as an antibacterial agent.
    Patent expiration dates:
    • January 29, 2021
      ✓ 
      Drug substance
    • July 29, 2021
      ✓ 
      Pediatric exclusivity

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.
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