Saturday 23 May 2009

Ozurdex


Ozurdex is a brand name of dexamethasone ophthalmic, approved by the FDA in the following formulation(s):


OZURDEX (dexamethasone - implant; intravitreal)



  • Manufacturer: ALLERGAN

    Approval date: June 17, 2009

    Strength(s): 0.7MG [RLD]

Has a generic version of Ozurdex been approved?


No. There is currently no therapeutically equivalent version of Ozurdex available.


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




  • Methods for treating inflammation-mediated conditions of the eye
    Patent 6,726,918
    Issued: April 27, 2004
    Inventor(s): Vernon G.; Wong & Mae W. L.; Hu
    Assignee(s): Oculex Pharmaceuticals, Inc.
    Methods for treating inflammation-mediated conditions of the eye are described, comprising: implanting into the vitreous of the eye of an individual a bioerodible implant comprising a steroidal anti-inflammatory agent and a bioerodible polymer, wherein the implant delivers the agent to the vitreous in an amount sufficient to reach a concentration equivalent to at least about 0.05 &mgr;g/ml dexamethasone within about 48 hours and maintains a concentration equivalent to at least about 0.03 &mgr;g/ml dexamethasone for at least about three weeks.
    Patent expiration dates:

    • October 20, 2020
      ✓ 
      Patent use: TREATMENT OF MACULAR EDEMA
      ✓ 
      Drug product


    • October 20, 2020
      ✓ 
      Patent use: TREATMENT OF UVEITIS
      ✓ 
      Drug product




  • Methods and apparatus for delivery of ocular implants
    Patent 6,899,717
    Issued: May 31, 2005
    Inventor(s): Weber; David & Kane; Ingrid & Rehal; Mike & Lathrop, III; Robert L. & Aptekarev; Kenny
    Assignee(s): Allergan, Inc.
    An apparatus and methods for delivering ocular implants or microimplants. The apparatus is ergonomically designed for ease of use, and a simple manual depression of an actuator produces proportional movement of a linkage causing the implant or microimplant to be ejected through a cannula disposed at the desired location in the eye. Small gauge cannulas are provided for self-sealing methods of delivery.
    Patent expiration dates:

    • November 1, 2023
      ✓ 
      Patent use: DELIVERING AN OCULAR IMPLANT AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION OF THE APPROVED LABELING OF OZURDEX




  • Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor
    Patent 7,033,605
    Issued: April 25, 2006
    Inventor(s): Wong; Vernon G.
    Assignee(s): Allergan, Inc.
    Methods for reducing or preventing transplant rejection in the eye of an individual are described, comprising: a) performing an ocular transplant procedure; and b) implanting in the eye a bioerodible drug delivery system comprising an immunosuppressive agent and a bioerodible polymer.
    Patent expiration dates:

    • October 20, 2020
      ✓ 
      Drug product




  • Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use
    Patent 7,767,223
    Issued: August 3, 2010
    Inventor(s): Wong; Vernon G.
    Assignee(s): Allergan, Inc.
    Methods for reducing or preventing transplant rejection in the eye of an individual are described, comprising: a) performing an ocular transplant procedure; and b) implanting in the eye a bioerodible drug delivery system comprising an immunosuppressive agent and a bioerodible polymer.
    Patent expiration dates:

    • November 28, 2021
      ✓ 
      Drug product




  • Ocular implant made by a double extrusion process
    Patent 8,034,366
    Issued: October 11, 2011
    Inventor(s): Shiah; Jane-Guo & Bhagat; Rahul & Blanda; Wendy M. & Nivaggioli; Thierry & Peng; Lin & Chou; David & Weber; David A.
    Assignee(s): Allergan, Inc.
    The invention provides biodegradable implants sized for implantation in an ocular region and methods for treating medical conditions of the eye. The implants are formed from a mixture of hydrophilic end and hydrophobic end PLGA, and deliver active agents into an ocular region without a high burst release.
    Patent expiration dates:

    • January 9, 2023
      ✓ 
      Patent use: TREATMENT OF UVEITIS
      ✓ 
      Drug product


    • January 9, 2023
      ✓ 
      Patent use: TREATMENT OF MACULAR EDEMA
      ✓ 
      Drug product




  • Ocular implant made by a double extrusion process
    Patent 8,034,370
    Issued: October 11, 2011
    Inventor(s): Shiah; Jane-Guo & Bhagat; Rahul & Blanda; Wendy M. & Nivaggioli; Thierry & Peng; Lin & Chou; David & Weber; David A.
    Assignee(s): Allergan, Inc.
    The invention provides biodegradable implants sized for implantation in an ocular region and methods for treating medical conditions of the eye. The implants are formed from a mixture of hydrophilic end and hydrophobic end PLGA, and deliver active agents into an ocular region without a high burst release.
    Patent expiration dates:

    • January 9, 2023
      ✓ 
      Drug product




  • Methods for reducing edema
    Patent 8,043,628
    Issued: October 25, 2011
    Inventor(s): Wong; Vernon G.
    Assignee(s): Allergan, Inc.
    Methods for reducing or preventing neovascularization or edema in the eye by implanting in the eye a bioerodible drug delivery system comprising an immunosuppressive agent and a bioerodible polymer.
    Patent expiration dates:

    • October 20, 2020
      ✓ 
      Patent use: TREATMENT OF MACULAR EDEMA
      ✓ 
      Drug product




  • Implants and methods for treating inflammation-mediated conditions of the eye
    Patent 8,063,031
    Issued: November 22, 2011
    Inventor(s): Wong; Vernon G. & Hu; Mae W. L.
    Assignee(s): Allergan, Inc.
    Methods for treating inflammation-mediated conditions of the eye are described, comprising: implanting into the vitreous of the eye of an individual a bioerodible implant comprising a steroidal anti-inflammatory agent and a bioerodible polymer, wherein the implant delivers the agent to the vitreous in an amount sufficient to reach a concentration equivalent to at least about 0.05 μg/ml dexamethasone within about 48 hours and maintains a concentration equivalent to at least about 0.03 μg/ml dexamethasone for at least about three weeks.
    Patent expiration dates:

    • October 20, 2020
      ✓ 
      Drug product




  • Method for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor
    Patent 8,088,407
    Issued: January 3, 2012
    Inventor(s): Wong; Vernon G
    Assignee(s): Allergan, Inc.
    Methods for reducing or preventing transplant rejection in the eye of an individual are described, comprising: a) performing an ocular transplant procedure; and b) implanting in the eye a bioerodible drug delivery system comprising an immunosuppressive agent and a bioerodible polymer.
    Patent expiration dates:

    • October 20, 2020
      ✓ 
      Patent use: TREATMENT OF MACULAR EDEMA
      ✓ 
      Drug product



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, 2012 - NEW DOSAGE FORM

    • September 24, 2017 - ORPHAN DRUG EXCLUSIVITY

See also...

  • Ozurdex Consumer Information (Drugs.com)
  • Ozurdex Consumer Information (Cerner Multum)
  • Ozurdex Advanced Consumer Information (Micromedex)
  • Dexamethasone Drops Consumer Information (Wolters Kluwer)
  • Dexamethasone Suspension Consumer Information (Wolters Kluwer)
  • Dexamethasone intravitreal implant Consumer Information (Cerner Multum)
  • Dexamethasone ophthalmic Consumer Information (Cerner Multum)
  • Dexamethasone Intraocular Advanced Consumer Information (Micromedex)

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