Generic Dextenza Availability
Last updated on Nov 6, 2024.
Dextenza is a brand name of dexamethasone ophthalmic, approved by the FDA in the following formulation(s):
DEXTENZA (dexamethasone - insert;ophthalmic)
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Manufacturer: OCULAR THERAPEUTIX
Approval date: November 30, 2018
Strength(s): 0.4MG [RLD]
Has a generic version of Dextenza been approved?
No. There is currently no therapeutically equivalent version of Dextenza available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dextenza. 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 FAQ.
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.
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Patent 11,458,041
Patent expiration dates:
- November 16, 2037✓
- November 16, 2037✓
- November 16, 2037
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Drug delivery through hydrogel plugs
Patent 8,409,606
Issued: April 2, 2013
Inventor(s): Sawhney Amarpreet S. & Jarrett Peter & Bassett Michael & Blizzard Charles
Assignee(s): Incept, LLCAn embodiment is a medical prosthesis for blocking or reducing tear flow through a punctum or canaliculus of a human eye and delivering a drug to the eye that comprises a dehydrated covalently crosslinked synthetic hydrophilic polymer hydrogel with dimensions to pass through a puncta lacrimali, with the dehydrated hydrogel absorbing physiological water to swell to at least 1 mm in cross-sectional width and conformably fit a canaliculus, with the hydrogel comprising a therapeutic agent dispersed through the hydrogel for release to an eye, with the hydrogel having a water content of at least about 50% by weight or volume when allowed to fully hydrate in vitro in physiological saline.
Patent expiration dates:
- May 14, 2030✓
- May 14, 2030
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Drug delivery through hydrogel plugs
Patent 8,563,027
Issued: October 22, 2013
Inventor(s): Jarrett Peter & Bassett Michael & Blizzard Charles D. & Sawhney Amarpreet S.
Assignee(s): Incept, LLCAn embodiment is a medical prosthesis for blocking or reducing tear flow through a punctum or canaliculus of a human eye and delivering a drug to the eye that comprises a dehydrated covalently crosslinked synthetic hydrophilic polymer hydrogel with dimensions to pass through a puncta lacrimali, with the dehydrated hydrogel absorbing physiological water to swell to at least 1 mm in cross-sectional width and conformably fit a canaliculus, with the hydrogel comprising a therapeutic agent dispersed through the hydrogel for release to an eye, with the hydrogel having a water content of at least about 50% by weight or volume when allowed to fully hydrate in vitro in physiological saline.
Patent expiration dates:
- February 12, 2030✓
- February 12, 2030
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Composite hydrogel drug delivery systems
Patent 9,254,267
Issued: February 9, 2016
Inventor(s): Sawhney Amarpreet S.
Assignee(s): Incept, LLCCompositions and methods are provided to control the release of relatively low molecular weight therapeutic species through hydrogels by first dispersing or dissolving such therapeutic species within relatively hydrophobic rate modifying agents to form a mixture. The mixture is formed into microparticles that are dispersed within bioabsorbable hydrogels, so as to release the water soluble therapeutic agents in a controlled fashion. Methods of using the compositions of the present invention in therapeutic systems are also provided.
Patent expiration dates:
- September 11, 2024✓
- September 11, 2024
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:
- October 7, 2024 - TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
More about Dextenza (dexamethasone ophthalmic)
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- During pregnancy
- FDA approval history
- Drug class: ophthalmic steroids
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.