Skip to Content

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] [AP], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [RLD] [AP]
  • Manufacturer: HOSPIRA
    Approval date: November 14, 2014
    Strength(s): EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) [RLD] [AP]
  • Manufacturer: HOSPIRA
    Approval date: January 31, 2020
    Strength(s): EQ 1MG BASE/250ML (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: ACCORD HLTHCARE
    Approval date: February 9, 2016
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: ACTAVIS INC
    Approval date: October 17, 2016
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: AKORN INC
    Approval date: November 24, 2014
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: AMNEAL PHARMS CO
    Approval date: May 20, 2020
    Strength(s): EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) [AP], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [AP]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: March 17, 2016
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: BAXTER HLTHCARE CORP
    Approval date: August 21, 2018
    Strength(s): EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) [AP], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [AP]
  • Manufacturer: FRESENIUS KABI USA
    Approval date: September 18, 2015
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: FRESENIUS KABI USA
    Approval date: November 29, 2018
    Strength(s): EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) [AP], EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) [AP], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [AP]
  • Manufacturer: GLAND PHARMA LTD
    Approval date: June 3, 2020
    Strength(s): EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) [AP], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [AP]
  • Manufacturer: HIKMA
    Approval date: January 30, 2020
    Strength(s): EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) [AP], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [AP]
  • Manufacturer: JIANGSU HENGRUI MED
    Approval date: September 19, 2017
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: JIANGSU HENGRUI MED
    Approval date: June 12, 2020
    Strength(s): EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) [AP], EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) [AP], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [AP]
  • 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]
  • Manufacturer: SANDOZ INC
    Approval date: June 14, 2016
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: SLAYBACK PHARMA LLC
    Approval date: December 4, 2019
    Strength(s): EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) [AP], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [AP]
  • Manufacturer: SUN PHARM INDS INC
    Approval date: August 20, 2015
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: TEVA PHARMS USA
    Approval date: November 28, 2017
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: WEST-WARD PHARMS INT
    Approval date: April 26, 2017
    Strength(s): EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) [AP]
  • Manufacturer: ZYDUS PHARMS
    Approval date: February 27, 2018
    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: Generic Drug FAQs.

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.

  • Dexmedetomidine premix formulation
    Patent 10,016,396
    Issued: July 10, 2018
    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
  • 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
      ✓ 
      Drug product
    • July 4, 2032
      ✓ 
      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
  • Dexmedetomidine premix formulation
    Patent 9,320,712
    Issued: April 26, 2016
    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
  • Dexmedetomidine premix formulation
    Patent 9,616,049
    Issued: April 11, 2017
    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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AP Injectable 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.