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Generic Ozurdex Availability

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 in the United States.

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
  • 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
  • Ocular implant made by a double extrusion process
    Patent 8,506,987
    Issued: August 13, 2013
    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
    • January 9, 2023
      ✓ 
      Patent use: TREATMENT OF MACULAR EDEMA
  • Implants and methods for treating inflammation-mediated conditions of the eye
    Patent 9,012,437
    Issued: April 21, 2015
    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
      ✓ 
      Patent use: TREATMENT OF MACULAR EDEMA
  • Ocular implant made by a double extrusion process
    Patent 9,192,511
    Issued: November 24, 2015
    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 treating edema in the eye and intraocular implants for use therefor
    Patent 9,283,178
    Issued: March 15, 2016
    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

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 29, 2017 - INDICATED FOR THE TREATMENT OF DIABETIC MACULAR EDEMA IN PATIENTS WHO ARE PSEUDOPHAKIC OR ARE PHAKIC AND SCHEDULED FOR CATARACT SURGERY
    • September 24, 2017 - ORPHAN DRUG 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.
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