Medication Guide App

Generic Precedex Availability

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

PRECEDEX (dexmedetomidine hydrochloride - injectable;injection)

  • Manufacturer: HOSPIRA
    Approval date: December 17, 1999
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [RLD] [AP]
  • Manufacturer: HOSPIRA
    Approval date: March 13, 2013
    Strength(s): EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) [RLD], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [RLD]

Has a generic version of Precedex been approved?

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

dexmedetomidine hydrochloride injectable;injection

  • Manufacturer: MYLAN INSTITUTIONAL
    Approval date: August 18, 2014
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: PAR STERILE PRODUCTS
    Approval date: August 18, 2014
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]

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

  • Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist
    Patent 4,910,214
    Issued: March 20, 1990
    Inventor(s): Karjalainen; Arto J. & Virtanen; Raimo E. & Savolainen; Eino J.
    Assignee(s): Farmos Yhtyma Oy
    The separated d and l enantiomers of medetomidine and their salts are selective and potent .alpha..sub.2 -receptor agonists.
    Patent expiration dates:
    • July 15, 2013
      ✓ 
      Patent use: USE FOR SEDATION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 15, 2014
      ✓ 
      Pediatric exclusivity
  • Use of dexmedetomidine for ICU sedation
    Patent 6,716,867
    Issued: April 6, 2004
    Inventor(s): Riku; Aantaa & Romeo; Bachand & Esa; Heinonen
    Assignee(s): Orion Corporation
    The present invention relates to a method of sedating a patient while in the intensive care unit comprising administering dexmedetomidine of a pharmaceutically acceptable salt thereof to the patient, wherein the patient remains arousable and orientated.
    Patent expiration dates:
    • March 31, 2019
      ✓ 
      Patent use: INTENSIVE CARE UNIT SEDATION, INCLUDING SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER PROCEDURES
    • October 1, 2019
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      Pediatric exclusivity
  • Dexmedetomidine premix formulation
    Patent 8,242,158
    Issued: August 14, 2012
    Inventor(s): Roychowdhury; Priyanka & Cedergren; Robert A.
    Assignee(s): Hospira, Inc.
    The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.
    Patent expiration dates:
    • January 4, 2032
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      Drug product
    • July 4, 2032
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      Pediatric exclusivity
  • Dexmedetomidine premix formulation
    Patent 8,338,470
    Issued: December 25, 2012
    Inventor(s): Roychowdhury; Priyanka & Cedergren; Robert A.
    Assignee(s): Hospira, Inc.
    The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.
    Patent expiration dates:
    • January 4, 2032
      ✓ 
      Drug product
    • July 4, 2032
      ✓ 
      Pediatric exclusivity
  • Methods of treatment using a dexmedetomidine premix formulation
    Patent 8,455,527
    Issued: June 4, 2013
    Assignee(s): Hospira, Inc.
    The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.
    Patent expiration dates:
    • January 4, 2032
      ✓ 
      Patent use: USE FOR SEDATION
    • July 4, 2032
      ✓ 
      Pediatric exclusivity
  • Dexmedetomidine premix formulation
    Patent 8,648,106
    Issued: February 11, 2014
    Assignee(s): Hospira, Inc.
    The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.
    Patent expiration dates:
    • January 4, 2032
      ✓ 
      Drug product
    • July 4, 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:
    • June 17, 2016 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
    • December 17, 2016 -

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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