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Generic Ofirmev Availability

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

OFIRMEV (acetaminophen - solution;iv (infusion))

  • Manufacturer: MALLINCKRODT IP
    Approval date: November 2, 2010
    Strength(s): 1GM/100ML (10MG/ML) [RLD] [AP]

Has a generic version of Ofirmev been approved?

A generic version of Ofirmev 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 Ofirmev and have been approved by the FDA:

acetaminophen solution;iv (infusion)

  • Manufacturer: PADDOCK LLC
    Approval date: June 13, 2016
    Strength(s): 1GM/100ML (10MG/ML) [AP]
  • Manufacturer: SANDOZ INC
    Approval date: March 22, 2016
    Strength(s): 1GM/100ML (10MG/ML) [AP]

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

  • Stable liquid paracetamol compositions, and method for preparing same
    Patent 6,028,222
    Issued: February 22, 2000
    Inventor(s): Dietlin; Francois & Fredj; Daniele
    Assignee(s): SCR Pharmatop
    Novel stable paracetamol compositions for use in therapeutic chemistry and specifically galenic pharmacy are disclosed. The compositions contain a solution of paracetamol in an aqueous solvent combined with a buffer having a pH of 4 to 8, and a free radical capturing agent. A water-insoluble inert gas is carefully bubbled through the aqueous solvent to remove oxygen from the medium. Said compositions may also be combined with a centrally or peripherally acting analgesic agent, and are provided as injectable compositions for relieving pain.
    Patent expiration dates:
    • August 5, 2017
      ✓ 
      Drug product
    • February 5, 2018
      ✓ 
      Pediatric exclusivity
  • Method for obtaining aqueous formulations of oxidation-sensitive active principles
    Patent 6,992,218
    Issued: January 31, 2006
    Inventor(s): Dietlin; Francois & Fredj; Daniele
    Assignee(s): Pharmatop SCR
    A method for obtaining aqueous formulations with easily oxidizable active principles, notably phenols, stable over a prolonged period, comprising subjecting them to extreme deoxygenation by bubbling with an inert gas and/or placing wider vaccum, protecting them against possible resorption of oxygen by keeping them under an inert gas atmosphere, by filling, under inert gas, into bottles previously cleared of air by insufflation with inert gas, then subjecting them, while stoppering, to low pressure as obtained in the bottle, of 65,000 Pa maximum, to obtain aqueous solutions having a residual oxygen concentration in the solution below 2 ppm, and preferably of the order of 1 ppm and even 0.5 ppm useful as injectable preparations having an oxygen concentration in the solution below 2 ppm.
    Patent expiration dates:
    • June 6, 2021
      ✓ 
      Drug product
    • December 6, 2021
      ✓ 
      Pediatric exclusivity
  • Reduced dose intravenous acetaminophen
    Patent 9,399,012
    Issued: July 26, 2016
    Assignee(s): MALLINCKRODT IP
    Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever.
    Patent expiration dates:
    • September 11, 2031
    • March 11, 2032
      ✓ 
      Pediatric exclusivity

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:
    • January 11, 2017 - 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.
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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