Generic Durezol Availability
DUREZOL (difluprednate - emulsion;ophthalmic)
Manufacturer: ALCON PHARMS LTD
Approval date: June 23, 2008
Strength(s): 0.05% [RLD]
Has a generic version of Durezol been approved?
No. There is currently no therapeutically equivalent version of Durezol available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Durezol. 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.
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.
Compositions containing difluprednate
Issued: September 5, 2000
Inventor(s): Kimura; Masako & Yasueda; Shin-ichi & Yamaguchi; Masazumi & Inada; Katsuhiro
Assignee(s): Senju Pharmaceutical Co., Ltd. Mitsubishi Chemical Corporation
The present invention relates to a liquid composition comprising difluprednate, oil, water and an emulsifier. The composition of the present invention has superior antiinflammatory action and antiallergic action. The composition of the present invention shows superior transfer to a lesion and uniform drug distribution upon administration, as compared to conventional preparations containing difluprednate, so that it shows sufficient efficacy in a smaller dose. The inventive composition is associated with extremely less uncomfortable feeling and foreign sensation upon administration, as compared to conventional preparations containing difluprednate, and it can be administered easily to local sites of eye, nose, ear and the like.Patent expiration dates:
- May 18, 2019✓
- November 18, 2019✓
- May 18, 2019
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 23, 2013 - NEW CHEMICAL ENTITY
- June 13, 2015 - TREATMENT OF ENDOGENOUS ANTERIOR UVEITIS
- December 13, 2015 - PEDIATRIC EXCLUSIVITY
- March 22, 2016 - REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO REFLECT THE RESULTS FROM CLINICAL STUDY C-10-004
- September 22, 2016 - PEDIATRIC EXCLUSIVITY
- June 13, 2019 - ORPHAN DRUG EXCLUSIVITY
- December 13, 2019 - PEDIATRIC EXCLUSIVITY
- Durezol Consumer Information (Drugs.com)
- Durezol emulsion Consumer Information (Wolters Kluwer)
- Durezol Consumer Information (Cerner Multum)
- Durezol Advanced Consumer Information (Micromedex)
- Durezol AHFS DI Monographs (ASHP)
- Difluprednate emulsion Consumer Information (Wolters Kluwer)
- Difluprednate ophthalmic Consumer Information (Cerner Multum)
- Difluprednate Ophthalmic Advanced Consumer Information (Micromedex)
- Difluprednate AHFS DI Monographs (ASHP)
|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.|