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Generic Renvela Availability

Renvela is a brand name of sevelamer, approved by the FDA in the following formulation(s):

RENVELA (sevelamer carbonate - for suspension;oral)

  • Manufacturer: GENZYME
    Approval date: February 18, 2009
    Strength(s): 2.4GM/PACKET [RLD] [AB]
  • Manufacturer: GENZYME
    Approval date: August 12, 2009
    Strength(s): 800MG/PACKET [RLD] [AB]

RENVELA (sevelamer carbonate - tablet;oral)

  • Manufacturer: GENZYME
    Approval date: October 19, 2007
    Strength(s): 800MG [RLD] [AB]

Has a generic version of Renvela been approved?

A generic version of Renvela has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Renvela and have been approved by the FDA:

sevelamer carbonate for suspension;oral

  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: June 13, 2017
    Strength(s): 800MG/PACKET [AB], 2.4GM/PACKET [AB]

sevelamer carbonate tablet;oral

  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: July 17, 2017
    Strength(s): 800MG [AB]

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.

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.

  • Aliphatic amine polymer salts for tableting
    Patent 7,985,418
    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
      ✓ 
      Drug product
  • Sachet formulation for amine polymers
    Patent 9,095,509
    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
      ✓ 
      Drug product

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:
    • November 25, 2019 - NEW PATIENT POPULATION
Glossary
TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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