Generic Azasite Availability

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

AZASITE (azithromycin - solution/drops;ophthalmic)

  • Manufacturer: OAK PHARMS AKORN
    Approval date: April 27, 2007
    Strength(s): 1% [RLD]

Has a generic version of Azasite been approved?

No. There is currently no therapeutically equivalent version of Azasite available in the United States.

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

  • Sustained release ophthalmic compositions containing water soluble medicaments
    Patent 6,159,458
    Issued: December 12, 2000
    Inventor(s): Bowman; Lyle M. & Pfeiffer; James F.
    Assignee(s): InSite Vision
    An ophthalmic composition that provides sustained release of a water soluble medicament is formed comprising a crosslinked carboxy-containing polymer, a medicament, a sugar and water. The composition has a pH of at least 6.7 but a viscosity of from about 1000 to 5000 cps.
    Patent expiration dates:
    • November 4, 2017
      ✓ 
      Patent use: METHOD OF COMBATING BACTERIA IN A PATIENT
      ✓ 
      Drug product
  • Topical treatment or prevention of ocular infections
    Patent 6,239,113
    Issued: May 29, 2001
    Inventor(s): Dawson; Chandler R. & Bowman; Lyle M.
    Assignee(s): InSite Vision, Incorporated
    The topical application of an azalide antibiotic such as azithromycin to the eye is useful in treating or preventing ocular infections. In one embodiment, the azalide antibiotic is supplied to the eye in a depot for sustained release. A more convenient dosing regimen can also be provided by the use of an appropriate depot. Furthermore, a composition containing a combination of medicaments is also provided.
    Patent expiration dates:
    • March 31, 2019
      ✓ 
      Patent use: METHOD OF COMBATING BACTERIA IN A PATIENT
  • Topical treatment or prevention of ocular infections
    Patent 6,569,443
    Issued: May 27, 2003
    Inventor(s): Chandler R.; Dawson & Lyle M.; Bowman
    Assignee(s): Insite Vision, Inc.
    The topical application of an azalide antibiotic such as azithromycin to the eye is useful in treating or preventing ocular infections. In one embodiment, the azalide antibiotic is supplied to the eye in a depot for sustained release. A more convenient dosing regimen can also be provided by the use of an appropriate depot. Furthermore, a composition containing a combination of medicaments is also provided.
    Patent expiration dates:
    • March 31, 2019
      ✓ 
      Patent use: METHOD OF COMBATING BACTERIA IN A PATIENT
      ✓ 
      Drug product
  • Method of treating eye infections with azithromycin
    Patent 6,861,411
    Issued: March 1, 2005
    Inventor(s): Ahmed; Imran
    Assignee(s): Pfizer, Inc.
    The invention features methods and compositions for treating ocular infections. The method comprises topically administering to an eye of an animal in need of such treatment an ocular infection-treating amount of azithromycin.
    Patent expiration dates:
    • November 25, 2018
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      Patent use: METHOD OF COMBATING BACTERIA IN A PATIENT
  • Topical treatment for prevention of ocular infections
    Patent 7,056,893
    Issued: June 6, 2006
    Inventor(s): Roy; Samir & Bowman; Lyle M.
    Assignee(s): Insite Vision, Inc.
    Azalide antibiotics such as azithromycin are useful in the treatment and prevention of infections by bacteria and other parasites. Stabilized aqueous compositions containing azithromycin suitable for administration without reconstitution are provided for. Also provided for are aqueous formulations suitable for ocular administration in a employing a convenient dosing formulation suitable for administration in depot formats.
    Patent expiration dates:
    • March 31, 2019
      ✓ 
      Patent use: METHOD OF COMBATING BACTERIA IN A PATIENT
      ✓ 
      Drug product

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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