Generic Ranexa Availability

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

RANEXA (ranolazine - tablet, extended release;oral)

  • Manufacturer: GILEAD
    Approval date: January 27, 2006
    Strength(s): 500MG [AB]
  • Manufacturer: GILEAD
    Approval date: February 12, 2007
    Strength(s): 1GM [RLD] [AB]

Has a generic version of Ranexa been approved?

A generic version of Ranexa 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 Ranexa and have been approved by the FDA:

ranolazine tablet, extended release;oral

  • Manufacturer: LUPIN LTD
    Approval date: July 29, 2013
    Strength(s): 500MG [AB], 1GM [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ranexa. 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.

  • Method for administering a sustained release ranolanolazine formulation
    Patent 6,303,607
    Issued: October 16, 2001
    Inventor(s): Wolff; Andrew A. & Baker; Fiona & Langridge; John Richard
    Assignee(s): CV Therapeutics, Inc.
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Patent use: TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
  • Sustained release ranolazine formulations
    Patent 6,369,062
    Issued: April 9, 2002
    Inventor(s): Andrew A.; Wolff & Fiona; Baker & John; Langridge
    Assignee(s): CV Therapeutics, Inc. Syntex (USA) Inc.
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Drug product
    • May 27, 2019
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
  • Methods for treating angina with ranolazine
    Patent 6,479,496
    Issued: November 12, 2002
    Inventor(s): Andrew A.; Wolff
    Assignee(s): CV Therapeutics, Inc.
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 850 and 4000 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Patent use: TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
  • Sustained release ranolazine formulations
    Patent 6,503,911
    Issued: January 7, 2003
    Inventor(s): Andrew A.; Wolff & Fiona; Baker & John; Langridge
    Assignee(s): CV Therapeutics, Inc. Syntex USA, Inc.
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Drug product
  • Sustained release ranolazine formulations
    Patent 6,525,057
    Issued: February 25, 2003
    Inventor(s): Andrew A.; Wolff & Fiona; Baker & John; Langridge
    Assignee(s): CV Therapeutics, Inc.
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Patent use: TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
  • Sustained release ranolazine formulations
    Patent 6,562,826
    Issued: May 13, 2003
    Inventor(s): Andrew A.; Wolff
    Assignee(s): CV Therapeutics, Inc.
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 850 and 4000 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Patent use: TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
  • Sustained release ranolazine formulations
    Patent 6,617,328
    Issued: September 9, 2003
    Inventor(s): Andrew A.; Wolff & Fiona; Baker & John; Langridge
    Assignee(s): CV Therapeutics, Inc Syntex (USA), LLC
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Drug product
  • Sustained release ranolazine formulations
    Patent 6,620,814
    Issued: September 16, 2003
    Inventor(s): Andrew A.; Wolff & Fiona; Baker & John; Langridge
    Assignee(s): CV Therapeutics, Inc.
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Patent use: TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
  • Sustained release ranolazine formulations
    Patent 6,852,724
    Issued: February 8, 2005
    Inventor(s): Wolff; Andrew A.
    Assignee(s): CV Therapeutics, Inc.
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 850 and 4000 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Patent use: TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
  • Sustained release ranolazine formulations
    Patent 6,864,258
    Issued: March 8, 2005
    Inventor(s): Wolff; Andrew A.
    A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
    Patent expiration dates:
    • May 27, 2019
      ✓ 
      Patent use: TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE

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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