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Generic Bydureon Availability

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

BYDUREON (exenatide synthetic - for suspension, extended release;subcutaneous)

  • Manufacturer: ASTRAZENECA AB
    Approval date: January 27, 2012
    Strength(s): 2MG/VIAL [RLD]
  • Manufacturer: ASTRAZENECA AB
    Approval date: February 28, 2014
    Strength(s): 2MG [RLD]

Has a generic version of Bydureon been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Bydureon. 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
  • Process for the preparation of polymer-based sustained release compositions
    Patent 6,479,065
    Issued: November 12, 2002
    Inventor(s): Warren E.; Jaworowicz & James I.; Wright
    Assignee(s): Alkermes Controlled Therapeutics, Inc.
    The invention relates to a sustained release composition and methods of forming and using said composition for the sustained release of biologically active agent. The sustained release compositions of the invention comprise a biocompatible polymer and a biologically active agent characterized by a porous center and a less porous outer layer wherein the center and outer layer consist of essentially the same materials. The sustained release compositions can be prepared by annealing at least a substantial portion of the exterior surface of a polymer/active agent matrix. The compositions which have been annealed exhibit a decrease in the release of agent over the first 24 hours following administration (i.e., reduced burst) and as a result can show an increase in the duration of sustained release thereby providing increased therapeutic benefits.
    Patent expiration dates:
    • August 10, 2020
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      Drug product
  • Preparation of injectable suspensions having improved injectability
    Patent 6,495,164
    Issued: December 17, 2002
    Inventor(s): J. Michael; Ramstack & M. Gary I.; Riley & Stephen E.; Zale & Joyce M.; Hotz & Olufunmi L.; Johnson
    Assignee(s): Alkermes Controlled Therapeutics, Inc. I
    Injectable compositions having improved injectability. The injectable compositions include microparticles suspended in an aqueous injection vehicle having a viscosity of at least 20 cp at 20° C. The increased viscosity of the injection vehicle that constitutes the fluid phase of the suspension significantly reduces in vivo injectability failures. The injectable compositions can be made by mixing dry microparticles with an aqueous injection vehicle to form a suspension, and then mixing the suspension with a viscosity enhancing agent to increase the viscosity of the fluid phase of the suspension to the desired level for improved injectability.
    Patent expiration dates:
    • May 25, 2020
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      Drug product
  • Preparation of injectable suspensions having improved injectability
    Patent 6,667,061
    Issued: December 23, 2003
    Inventor(s): J. Michael; Ramstack & M. Gary I.; Riley & Stephen E.; Zale & Joyce M.; Hotz & Olufunmi L.; Johnson
    Assignee(s): Alkermes Controlled Therapeutics, Inc.
    Injectable compositions having improved injectability. The injectable compositions include microparticles suspended in an aqueous injection vehicle having a viscosity of at least 20 cp at 20° C. The increased viscosity of the injection vehicle that constitutes the fluid phase of the suspension significantly reduces in vivo injectability failures. The injectable compositions can be made by mixing dry microparticles with an aqueous injection vehicle to form a suspension, and then mixing the suspension with a viscosity enhancing agent to increase the viscosity of the fluid phase of the suspension to the desired level for improved injectability.
    Patent expiration dates:
    • May 25, 2020
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      Drug product
  • Residual solvent extraction method and microparticles produced thereby
    Patent 6,824,822
    Issued: November 30, 2004
    Inventor(s): Michael E.; Rickey & J. Michael; Ramstack & Rajesh; Kumar
    Assignee(s): Alkermes Controlled Therapeutics Inc. II
    Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.
    Patent expiration dates:
    • October 9, 2022
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      Drug product
  • 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
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      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
      ✓ 
      Patent use: LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF, INCLUDING ONE WITH TYPE 2 DIABETES, BY ADMINISTERING AN EXENDIN OR ANALOG, SUCH AS EXENDIN-4
  • 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
  • Residual solvent extraction method and microparticles produced thereby
    Patent 7,223,440
    Issued: May 29, 2007
    Inventor(s): Rickey; Michael E. & Ramstack; J. Michael & Kumar; Rajesh
    Assignee(s): Alkermes, Inc.
    Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.
    Patent expiration dates:
    • August 31, 2021
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      Drug product
  • Polymer-based sustained release device
    Patent 7,456,254
    Issued: November 25, 2008
    Inventor(s): Wright; Steven G. & Christenson; Troy & Yeah; Thean Y. & Rickey; Michael E. & Hotz; Joyce M. & Kumar; Rajesh & Costantino; Henry R.
    Assignee(s): Alkermes, Inc.
    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
    Patent expiration dates:
    • June 30, 2025
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      Patent use: METHOD FOR TREATING TYPE 2 DIABETES USING A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENATIDE
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      Drug product
  • Polymer-based sustained release device
    Patent 7,563,871
    Issued: July 21, 2009
    Inventor(s): Wright; Steven G. & Christensen; Troy & Yeoh; Thean & Rickey; Michael E. & Hotz; Joyce M. & Kumar; Rajesh & Fineman; Mark & Smith; Christine & Ong; John & Lokensgard; David & Costantino; Henry R.
    Assignee(s): Alkermes, Inc. Amylin Pharmaceuticals, Inc.
    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
    Patent expiration dates:
    • April 15, 2024
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      Drug product
  • Polymer-based sustained release device
    Patent 7,612,176
    Issued: November 3, 2009
    Inventor(s): Wright; Steven G. & Christensen; Troy & Yeoh; Thean & Rickey; Michael E. & Hotz; Joyce M. & Kumar; Rajesh & Costantino; Henry R.
    Assignee(s): Alkermes, Inc.
    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
    Patent expiration dates:
    • April 13, 2025
      ✓ 
      Patent use: METHOD FOR TREATING TYPE 2 DIABETES USING A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENATIDE
      ✓ 
      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
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      Patent use: REDUCTIONS IN BODY WEIGHT ARE OBSERVED WITH EXENATIDE
  • Administering apparatus with functional drive element
    Patent 8,216,180
    Issued: July 10, 2012
    Inventor(s): Tschirren; Markus & Moser; Ulrich & Hirschel; Juerg & Baumert; Jan & Hattler; Eric
    Assignee(s): TecPharma Licensing AG
    An apparatus for administering a fluid product, including a housing, a product member for accommodating the fluid product and/or a reservoir for the fluid product, which product member can be moved relative to the housing from a start position to an inserted position along a longitudinal axis of the housing, a drive member in the housing and movable relative to the product member for emptying the fluid product from the product member and/or the reservoir, wherein the drive member has at least one holding element which holds the drive member in the start position of the product member and wherein, by the movement of the product member, the holding element is moved from the holding position to a released position in which the drive member is movable relative to the housing.
    Patent expiration dates:
    • January 12, 2028
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      Drug product
  • Methods for treating diabetes and reducing body weight
    Patent 8,329,648
    Issued: December 11, 2012
    Inventor(s): Fineman; Mark & MacConell; Leigh & Taylor; Kristin
    Assignee(s): Amylin Pharmaceuticals, LLC
    Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.
    Patent expiration dates:
    • August 18, 2026
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      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
  • Polymer-based sustained release device
    Patent 8,431,685
    Issued: April 30, 2013
    Assignee(s): Alkermes Pharma Ireland Limited
    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
    Patent expiration dates:
    • April 13, 2025
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      Patent use: TREATMENT OF TYPE 2 DIABETES
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      Drug product
  • Device for administering fluid from a multi-chamber ampoule in incremental steps
    Patent 8,439,864
    Issued: May 14, 2013
    Assignee(s): TecPharma Licensing AG
    An administering device for administering an active substance from a multi-chamber container comprising a first chamber holding a solid active substance and a second chamber holding a dissolving liquid for the active substance, wherein the administering device comprises a mixing device for mixing the active substance with the dissolving liquid and a housing accommodating the mixing device, the container being moveable relative to the housing, and the administering device further comprising a first indicator for indicating a position of the container relative to the housing upon completion of a mixing step, and a second indicator for indicating a position of the container relative to the housing upon completion of a venting step.
    Patent expiration dates:
    • March 25, 2028
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      Drug product
  • Polymer-based sustained release device
    Patent 8,461,105
    Issued: June 11, 2013
    Assignee(s): Alkermes Pharma Ireland Limited
    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
    Patent expiration dates:
    • April 13, 2025
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES
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      Drug product
  • Method for treating diabetes
    Patent 8,906,851
    Issued: December 9, 2014
    Assignee(s): Amylin Pharmaceuticals, LLC AstraZeneca Pharmaceuticals LP
    Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.
    Patent expiration dates:
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
  • Polymer-based sustained release device
    Patent 9,238,076
    Issued: January 19, 2016
    Assignee(s): Alkermes Pharma Ireland Limited Amylin Pharmaceuticals, LLC
    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
    Patent expiration dates:
    • April 15, 2024
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES
      ✓ 
      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:
    • September 24, 2018 - INCLUSION OF EFFICACY AND SAFETY DATA TO THE PRESCRIBING INFORMATION OF BYDUREON BASED ON STUDY GWDE

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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