Generic Dyloject Availability
DYLOJECT (diclofenac sodium - solution;intravenous)
Manufacturer: JAVELIN PHARMS INC
Approval date: December 23, 2014
Strength(s): 37.5MG/ML (37.5MG/ML) [RLD]
Has a generic version of Dyloject been approved?
No. There is currently no therapeutically equivalent version of Dyloject available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dyloject. 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.
Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation
Issued: June 18, 2002
Inventor(s): Bernd W.; Müller & Ulrich; Brauns
Assignee(s): Janssen Pharmaceutica N.V.
Pharmaceutical compositions comprising inclusion compounds of sparingly water-soluble or water-instable drugs with &bgr;-cyclodextrin ethers or &bgr;-cyclodextrin esters and process for the preparation thereof.Patent expiration dates:
- June 18, 2019✓
- June 18, 2019
Formulations of low dose diclofenac and beta-cyclodextrin
Issued: February 3, 2015
Assignee(s): Javelin Pharmaceuticals, Inc.
The present invention is directed to a pharmaceutical composition containing a unit dose of a diclofenac compound effective to induce analgesia; and a beta-cyclodextrin compound; wherein the dose of the diclofenac compound is less than 75 mg, e.g., from about 18.75 mg to about 37.5 mg. The present invention is also directed to methods of treating a subject in need of analgesia with the pharmaceutical compositions of the invention.Patent expiration dates:
- March 22, 2027✓
- March 22, 2027
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:
- December 23, 2017 - NEW PRODUCT
More about Dyloject (diclofenac)
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- Dosage Information
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|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.|