Generic Lotemax Availability

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

LOTEMAX (loteprednol etabonate - gel;ophthalmic)

  • Manufacturer: BAUSCH AND LOMB INC
    Approval date: September 28, 2012
    Strength(s): 0.5% [RLD]

LOTEMAX (loteprednol etabonate - ointment;ophthalmic)

LOTEMAX (loteprednol etabonate - suspension/drops;ophthalmic)

Has a generic version of Lotemax been approved?

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

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

  • Suspension of loteprednol etabonate for ear, eye, or nose treatment
    Patent 5,540,930
    Issued: July 30, 1996
    Inventor(s): Guy; Yaacov J. & Friedman; Doron I.
    Assignee(s): Pharmos Corporation
    The invention provides novel compositions of matter containing water-insoluble steroid drugs suitable for therapeutic use. The invention provides stable aqueous suspensions of water-insoluble steroid drugs of particle sizes of .ltoreq.15 .mu.m which remain in such a state so as to allow for immediate suspension, when desired, even after extended periods of settling.
    Patent expiration dates:
    • October 25, 2013
    • April 25, 2014
      ✓ 
      Pediatric exclusivity
  • Suspension of loteprednol etabonate for ear, eye, or nose treatment
    Patent 5,747,061
    Issued: May 5, 1998
    Inventor(s): Amselem; Shimon & Friedman; Doron
    Assignee(s): Pharmos Corporation
    The invention provides novel compositions of matter for delivering water-insoluble steroid drugs suitable for therapeutic use. The invention also provides stable aqueous suspensions of water-insoluble steroid drugs of particle sizes of .ltoreq.30 .mu.m which remain in such a state so as to allow for immediate suspension, when desired, even after extended periods of settling.
    Patent expiration dates:
    • October 25, 2013
      ✓ 
      Patent use: LOTEMAX OPTHALMIC SUSPENSION IS INDICATED FOR THE TREATMENT OF STEROID RESPONSIVE CONDITIONS OF THE PALPEBRAL BULBAR CONJUNCTIVA, CORNEA AND ANTERIOR SEGMENT OF THE GLOBE.
      ✓ 
      Drug product
    • April 25, 2014
      ✓ 
      Pediatric exclusivity
  • Ophthalmic compositions including glycerin and propylene glycol
    Patent 5,800,807
    Issued: September 1, 1998
    Inventor(s): Hu; Zhenze & Denick; John
    Assignee(s): Bausch & Lomb Incorporated
    There are disclosed ophthalmic compositions having high water-binding properties which are useful as: moisturizing and lubricating (i.e. artificial tear) solutions, dry eye therapies, contact lens wetting and lubricating solutions, and as delivery vehicles for ophthalmic drugs. The subject compositions include glycerin in combination with propylene glycol. The subject compositions may further include cellulose derivatives, e.g. hydroxypropyl methyl cellulose, along with preservatives, e.g. benzylalkonium chloride, PHMB, sorbic acid, etc. Preferred compositions have at least 11% bound water, a pH from about 7.1 to 7.5, and an osmolality between about 280 to about 320 mOsm/Kg.
    Patent expiration dates:
    • January 29, 2017
      ✓ 
      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:
    • April 15, 2014 -
    • October 15, 2014 -
    • September 28, 2015 -

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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