Generic Veletri Availability
VELETRI (epoprostenol sodium - injectable;injection)
Manufacturer: ACTELION PHARMS LTD
Approval date: June 27, 2008
Strength(s): EQ 1.5MG BASE/VIAL [RLD]
Manufacturer: ACTELION PHARMS LTD
Approval date: June 28, 2012
Strength(s): EQ 0.5MG BASE/VIAL
Has a generic version of Veletri been approved?
No. There is currently no therapeutically equivalent version of Veletri available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Veletri. 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.
Epoprostenol formulation and method of making thereof
Issued: November 27, 2012
Inventor(s): Palepu; Naglesh R.
Assignee(s): Actelion Pharmaceuticals Ltd.
This invention relates to a stable epoprostenol composition that can be combined with commercially available IV fluids and can be administered in its reconstituted and/or diluted form under ambient conditions of about 15-30° C. for greater than 24 hours. The composition preferably contains (a) epoprostenol or a salt thereof; (b) a alkalinization agent; and (c) a base, such that when reconstituted or in solution, the solution has a pH>11. Methods for making the lyophilized composition are also disclosed.Patent expiration dates:
- March 15, 2027✓
- March 15, 2027
- Veletri Consumer Information (Wolters Kluwer)
- Veletri Consumer Information (Cerner Multum)
- Veletri Advanced Consumer Information (Micromedex)
- Epoprostenol Consumer Information (Wolters Kluwer)
- Epoprostenol Consumer Information (Cerner Multum)
- Epoprostenol Intravenous Advanced Consumer Information (Micromedex)
- Epoprostenol Sodium 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.|