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Generic NeoProfen Availability

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

NEOPROFEN (ibuprofen lysine - injectable;intravenous)

  • Manufacturer: RECORDATI RARE
    Approval date: April 13, 2006
    Strength(s): EQ 20MG BASE/2ML (EQ 10MG BASE/ML) [RLD] [AP]

Has a generic version of NeoProfen been approved?

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

ibuprofen lysine injectable;intravenous

  • Manufacturer: EXELA PHARMA SCIENCE
    Approval date: March 30, 2016
    Strength(s): EQ 20MG BASE/2ML (EQ 10MG BASE/ML) [AP]

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

  • Composition and method for parenteral administration of ibuprofen d,l- or l-lysine salt
    Patent 6,342,530
    Issued: January 29, 2002
    Inventor(s): Laszlo; Darko
    Assignee(s): Farmacon-Il, LLC
    Pharmaceutical compositions are disclosed suitable for parenteral administration having anti-inflammatory, analgesic, and anti-pyretic properties, which consist of a therapeutically effective amount of d,l or l-lysine salt of R,S or S-ibuprofen as active ingredient dissolved in sterile water to form a solution in the absence of an inert atmosphere and either substantially free or absolutely free of any excipient, organic solvent, buffer, acid, base, salt other than the active ingredient and capable of storage in the absence of an inert atmosphere. Also disclosed are methods employing the new compositions in the treatment of pain and inflammation, in reducing fever and in treating patent ductus arterious or intraventricular hemorrhage in prematurely born neonates.
    Patent expiration dates:
    • November 14, 2020
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      Patent use: TREATMENT OF PATENT DUCTUS ARTERIOSUS
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      Drug product
    • November 14, 2020
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      Patent use: CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
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      Drug product
  • Method of preventing retinopathy of prematurity in a neonate
    Patent 6,344,479
    Issued: February 5, 2002
    Inventor(s): Bart; Van Overmeire & Laszlo; Darko
    Assignee(s): Farmacon-Il, LLC
    A method is disclosed of preventing retinopathy of prematurity in a prematurely born neonate susceptible to developing retinopathy of prematurity, which comprises the step of parenterally administering to said prematurely born neonate, a therapeutically effective amount of a water-soluble, pharmaceutically effective salt of ibuprofen as an active ingredient to promote retinal and choroidal blood flow autoregulation in said neonate.
    Patent expiration dates:
    • March 20, 2021
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      Patent use: CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
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      Drug substance
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      Drug product
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      Sponsor has requested patent be delisted
  • Ibuprofen compositions and methods of making same
    Patent 8,415,337
    Issued: April 9, 2013
    Assignee(s): Recordati Rare Diseases Inc.
    The present invention provides an improved ibuprofen lysine pharmaceutical composition and a process for preparing the same.
    Patent expiration dates:
    • March 2, 2032
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      Drug substance
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      Drug product

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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