Generic Renvela Availability
RENVELA (sevelamer carbonate - for suspension;oral)
Approval date: February 18, 2009
Strength(s): 2.4GM/PACKET [RLD]
Approval date: August 12, 2009
RENVELA (sevelamer carbonate - tablet;oral)
Has a generic version of Renvela been approved?
An Authorized Generic version of Renvela has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance, and unlike a generic, the Authorized Generic has exactly the same inactive ingredients.
List of authorized generic versions:
- sevelamer carbonate ORAL TABLET, FILM COATED 800 mg
Global Pharmaceuticals Division of IMPAX Laboratories, Inc.
NDC Code: 001151494
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Renvela. 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.
Aliphatic amine polymer salts for tableting
Issued: July 26, 2011
Inventor(s): Bhagat; Hitesh R. & Goldberg; Jeffrey M. & Harianawala; Abizer I. & Brenner; Louis
Assignee(s): Genzyme Corporation
The tablets, compositions and methods of the present invention, comprising a carbonate salt of an aliphatic amine polymer and s monovalent anion can prevent or ameliorate acidosis, in particular acidosis in patients with renal disease. The tablets and compositions of the present invention maintain a disintegration time of no greater than 30 minutes at 37° C. and at pH of at least 1 for a period of at least ten weeks at 60° C. Furthermore, the tablets are stable for extended periods of time without the need for specialized storage conditions.Patent expiration dates:
- October 27, 2025✓
- October 27, 2025
Sachet formulation for amine polymers
Issued: August 4, 2015
Assignee(s): Genzyme Corporation
A powder formulation comprises a pharmaceutically acceptable anionic stabilizer and an aliphatic amine polymer or a pharmaceutically acceptable salt thereof mixed with the anionic stabilizer. The powder formulation is conveniently packaged in a container, such as a sachet. A method of treating a subject with hyperphosphotemia with the powder formulation is also disclosed.Patent expiration dates:
- December 6, 2030✓
- December 6, 2030
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:
- November 25, 2019 - NEW PATIENT POPULATION
More about Renvela (sevelamer)
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Other brands: Renagel
Related treatment guides
|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.|