Generic Byetta Availability

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

BYETTA (exenatide synthetic - injectable;subcutaneous)

  • Manufacturer: ASTRAZENECA AB
    Approval date: April 28, 2005
    Strength(s): 300MCG/1.2ML (250MCG/ML) [RLD], 600MCG/2.4ML (250MCG/ML) [RLD]

Has a generic version of Byetta been approved?

No. There is currently no therapeutically equivalent version of Byetta available in the United States.

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

  • Exendin-3 and exendin-4 polypeptides, and pharmaceutical compositions comprising same
    Patent 5,424,286
    Issued: June 13, 1995
    Inventor(s): Eng; John
    This invention encompasses pharmaceutical compositions containing exendin-3 or exendin-4, fragments thereof, or any combination thereof, and methods for the treatment of diabetes mellitus and the prevention of hyperglycemia.
    Patent expiration dates:
    • December 1, 2016
      ✓ 
      Patent use: TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE
    • December 1, 2016
      ✓ 
      Patent use: STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE
  • Methods for regulating gastrointestinal motility
    Patent 6,858,576
    Issued: February 22, 2005
    Inventor(s): Young; Andrew A. & Gedulin; Bronislava & Beeley; Nigel Robert Arnold & Prickett; Kathryn S.
    Assignee(s): Amylin Pharmaceuticals, Inc.
    Methods for reducing gastric motility and delaying gastric emptying for therapeutic and diagnostic purposes are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist. Methods for treating conditions associated with elevated, inappropriate, or undesired post-prandial blood glucose levels are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist alone or in conjunction with other anti-gastric emptying agents.
    Patent expiration dates:
    • January 6, 2017
      ✓ 
      Patent use: REDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN EXENDIN, SUCH AS EXENDIN-4
  • Methods for glucagon suppression
    Patent 6,872,700
    Issued: March 29, 2005
    Inventor(s): Young; Andrew A. & Gedulin; Bronislava
    Assignee(s): Amylin Pharmaceuticals, Inc.
    Methods for use of an exendin, an exendin agonist, or a modified exendin or exendin agonist having an exendin or exendin agonist linked to one or more polyethylene glycol polymers, for example, for lowering glucagon levels and/or suppressing glucagon secretion in a subject are provide. These methods are useful in treating hyperglucagonemia and other conditions that would be benefited by lowering plasma glucagon or suppressing glucagon secretion.
    Patent expiration dates:
    • January 14, 2020
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      Patent use: LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF, INCLUDING ONE WITH TYPE 2 DIABETES, BY ADMINISTERING AN EXEDIN OR ANALOG, SUCH AS EXENDIN-4
  • Exendin agonist formulations and methods of administration thereof
    Patent 6,902,744
    Issued: June 7, 2005
    Inventor(s): Kolterman; Orville G. & Young; Andrew A.
    Assignee(s): Amylin Pharmaceuticals, Inc.
    Novel exendin and exendin agonist compound formulations and dosages and methods of administration thereof are provided. These compositions and methods are useful in treating diabetes and conditions that would be benefited by lowering plasma glucose or delaying and/or slowing gastric emptying or inhibiting food intake.
    Patent expiration dates:
    • January 14, 2020
      ✓ 
      Drug product
  • Use of exendins for the reduction of food intake
    Patent 6,956,026
    Issued: October 18, 2005
    Inventor(s): Beeley; Nigel Robert Arnold & Bhavsar; Sunil
    Assignee(s): Amylin Pharmaceuticals, Inc.
    Methods for treating conditions or disorders which can be alleviated by reducing food intake are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist, alone or in conjunction with other compounds or compositions that affect satiety. The methods are useful for treating conditions or disorders, including obesity, Type II diabetes, eating disorders, and insulin-resistance syndrome. The methods are also useful for lowering the plasma glucose level, lowering the plasma lipid level, reducing the cardiac risk, reducing the appetite, and reducing the weight of subjects. Pharmaceutical compositions for use in the methods of the invention are also disclosed.
    Patent expiration dates:
    • January 7, 2018
      ✓ 
      Patent use: REDUCING FOOD INTAKE IN A SUBJECT WITH TYPE 2 DIABETES BY ADMINISTERING AN EXENDIN, SUCH AS EXENDIN-4
  • Pharmaceutical compositions containing exendins
    Patent 7,297,761
    Issued: November 20, 2007
    Inventor(s): Beeley; Nigel Robert Arnold & Prickett; Kathryn S. & Bhavsar; Sunil & Young; Andrew & Gedulin; Bronislava
    Assignee(s): Amylin Pharmaceuticals, Inc.
    Methods for treating conditions or disorders which can be alleviated by reducing food intake are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist, alone or in conjunction with other compounds or compositions that affect satiety. The methods are useful for treating conditions or disorders, including obesity, Type II diabetes, eating disorders, and insulin-resistance syndrome. The methods are also useful for lowering the plasma glucose level, lowering the plasma lipid level, reducing the cardiac risk, reducing the appetite, and reducing the weight of subjects. Pharmaceutical compositions for use in the methods of the invention are also disclosed.
    Patent expiration dates:
    • October 15, 2017
      ✓ 
      Drug product
  • Exendin pharmaceutical compositions
    Patent 7,521,423
    Issued: April 21, 2009
    Inventor(s): Young; Andrew A. & Gedulin; Bronislava
    Assignee(s): Amylin Pharmaceuticals, Inc.
    Methods for reducing gastric motility and delaying gastric emptying for therapeutic and diagnostic purposes are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist. Methods for treating conditions associated with elevated, inappropriate, or undesired post-prandial blood glucose levels are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist alone or in conjunction with other anti-gastric emptying agents.
    Patent expiration dates:
    • October 15, 2017
      ✓ 
      Drug product
  • Exendins and exendin agonists for weight reduction and obesity
    Patent 7,741,269
    Issued: June 22, 2010
    Inventor(s): Young; Andrew A. & Bhavsar; Sunil & Gedulin; Bronislava
    Assignee(s): Amylin Pharmaceuticals, Inc.
    Methods for treating conditions or disorders which can be alleviated by reducing food intake are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist, alone or in conjunction with other compounds or compositions that affect satiety. The methods are useful for treating conditions or disorders, including obesity, Type II diabetes, eating disorders, and insulin-resistance syndrome. The methods are also useful for lowering the plasma glucose level, lowering the plasma lipid level, reducing the cardiac risk, reducing the appetite, and reducing the weight of subjects. Pharmaceutical compositions for use in the methods of the invention are also disclosed.
    Patent expiration dates:
    • January 7, 2018
      ✓ 
      Patent use: USE OF EXENATIDE MAY RESULT IN REDUCTION IN BODY WEIGHT

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:
    • October 19, 2014 - LABELING CHANGES BASED ON STUDY HW80-EW-GWCI ENTITLED A PLACEBO AND POSITIVE CONTROLLED STUDY OF THE ELECTROPHYSIOLOGICAL EFFECTS OF A SINGLE 10 MCG DOSE OF EXENATIDE ON THE 12 LEAD ELECTROCARDIOGRAM QT INTERVAL IN HEALTHY SUBJECTS
    • October 19, 2014 - LABELING CHANGES BASED ON STUDY H80-US-GWCO ENTITLED A RANDOMIZED TRIAL COMPARING EXENATIDE WITH PLACEBO IN SUBJECTS WITH TYPE 2 DIABETES ON INSULIN GLARGINE WITH OR WITHOUT ORAL ANTIHYPERGLYCEMIC MEDICATIONS

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.
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