Wednesday, October 19, 2016

Lotemax


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


LOTEMAX (loteprednol etabonate - ointment; ophthalmic)



  • Manufacturer: BAUSCH AND LOMB

    Approval date: April 15, 2011

    Strength(s): 0.5% [RLD]

LOTEMAX (loteprednol etabonate - suspension/drops; ophthalmic)



  • Manufacturer: BAUSCH AND LOMB

    Approval date: March 9, 1998

    Strength(s): 0.5% [RLD]

Has a generic version of Lotemax been approved?


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


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.




  • Soft steroids having anti-inflammatory activity
    Patent 4,996,335
    Issued: February 26, 1991
    Inventor(s): Bodor; Nicholas S.
    Assignee(s): Bodor; Nicholas S.
    The invention provides novel soft steroidal anti-inflammatory agents, pharmaceutical compositions containing said agents, and methods of administering same to mammals in the treatment of inflammation. Preferred compounds of the invention include haloalkyl 17.alpha.-alkoxycarbonyloxy-11.beta.-hydroxyandrost-4-en-3-one-17.beta.-ca rboxylates and the corresponding .DELTA..sup.1,4 compounds, optionally bearing 6.alpha.- and/or 9.alpha.-fluorine and 16.alpha.- or 16.beta.-methyl substituents. Especially preferred compounds include haloalkyl 17.alpha.-alkoxycarbonyloxy-9.alpha.-fluoro-11.beta.-hydroxy-16-methylandr osta-1,4-dien-3-one-17.beta.-carboxylates.
    Patent expiration dates:

    • March 9, 2012


    • September 9, 2012
      ✓ 
      Pediatric exclusivity




  • 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



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 - NEW DOSAGE FORM

    • October 15, 2014 - PEDIATRIC EXCLUSIVITY

See also...

  • Lotemax Drops Consumer Information (Wolters Kluwer)
  • Lotemax Ointment Consumer Information (Wolters Kluwer)
  • Lotemax Consumer Information (Cerner Multum)
  • Lotemax Advanced Consumer Information (Micromedex)
  • Loteprednol Drops Consumer Information (Wolters Kluwer)
  • Loteprednol Ointment Consumer Information (Wolters Kluwer)
  • Loteprednol ophthalmic Consumer Information (Cerner Multum)
  • Loteprednol Ophthalmic Advanced Consumer Information (Micromedex)
  • Loteprednol Etabonate AHFS DI Monographs (ASHP)

No comments:

Post a Comment