Generic Symbicort Availability

Symbicort is a brand name of budesonide/formoterol, approved by the FDA in the following formulation(s):

SYMBICORT (budesonide; formoterol fumarate dihydrate - aerosol, metered;inhalation)

  • Manufacturer: ASTRAZENECA
    Approval date: July 21, 2006
    Strength(s): 0.08MG/INH;0.0045MG/INH [RLD], 0.16MG/INH;0.0045MG/INH [RLD]

Has a generic version of Symbicort been approved?

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

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

  • Combination of a bronchodilator and a steroidal anti-inflammatory drug for the treatment of respiratory disorders
    Patent 5,674,860
    Issued: October 7, 1997
    Inventor(s): Carling; Christer Carl Gustav & Trofast; Jan William
    Assignee(s): Astra Aktiebolag
    Effective amounts of formoterol and/or a physiologically acceptable salt and/or solvate thereof and budesonide are used in combination for simultaneous, sequential or separate administration by inhalation in the treatment of an inflammatory respiratory disorder, such as asthma.
    Patent expiration dates:
    • October 7, 2014
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      Patent use: USE FOR THE TREATMENT OF ASTHMA
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      Drug product
  • Pressurized aerosol inhalation compositions
    Patent 6,123,924
    Issued: September 26, 2000
    Inventor(s): Mistry; Suresh N & Gibson; Mark
    Assignee(s): Fisons plc
    Pressurized aerosol inhalation composition consisting essentially of a liquefied hydrofluoroalkane, a powdered medicament dispersible to form a suspension in the liquefied hydrofluoroalkane, and polyvinylpyrrolidone present in a concentration of 0.00001 to 10% w/w.
    Patent expiration dates:
    • September 26, 2017
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      Drug product
  • Inhalation device
    Patent 7,367,333
    Issued: May 6, 2008
    Inventor(s): Hodson; Darren & Rasmussen; Jorgen
    Assignee(s): AstraZeneċa AB
    Actuator for an inhaler for delivering medicament by inhalation. The actuator includes a main body having a tubular member for receiving a canister containing medicament and having a valve stem extending therefrom, and an outlet assembly, as a part formed separately of the main body, having a mouthpiece for guiding medicament to the mouth of a user and a nozzle block for receiving the valve stem of the canister and delivering medicament from the canister into the mouthpiece. At least a part of the outlet assembly is configured so as to deform and optionally break on withdrawal of the outlet assembly from the main body so as to prevent re-use of the outlet assembly.
    Patent expiration dates:
    • November 11, 2018
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      Drug product
  • Inhaler device counter
    Patent 7,587,988
    Issued: September 15, 2009
    Inventor(s): Bowman; Nic & Bradshaw; Douglas & Sörby; Lennart
    Assignee(s): AstraZeneca AB
    Inhaler counter (20) comprising a counter housing (390), a rocker arm (200) with a pawl (210), the rocker arm being pivotally supported by the housing and arranged to perform a rocker movement in response to a linear actuation motion, a return spring (220) for resetting the rocker arm, a ratchet wheel (230) engagable with the pawl to convert the movement of the rocker arm into an incremental rotational motion of an axle arrangement (240) advancing a display means (60), the axle arrangement further comprising a back rotation prevention means (280) in the form of a spring loaded friction brake and a worm gear, the display means comprising rotatable indicator means (120) with teeth that engage the worm-gear and a stationary scale.
    Patent expiration dates:
    • April 10, 2026
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      Drug product
  • Composition for inhalation
    Patent 7,759,328
    Issued: July 20, 2010
    Inventor(s): Govind; Nayna & Marlow; Maria
    Assignee(s): AstraZeneca AB
    The invention relates to a formulation comprising formoterol and budesonide for use in the treatment of respiratory diseases. The composition further contains HFA 227, PVP and PEG, preferably PVP K25 and PEG 1000.
    Patent expiration dates:
    • January 29, 2023
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      Patent use: USE FOR THE TREATMENT OF ASTHMA AND COPD
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      Drug product
  • Use for budesonide and formoterol
    Patent 7,897,646
    Issued: March 1, 2011
    Inventor(s): Bauer; Carl-Axel & Trofast; Jan
    Assignee(s): AstraZeneca AB
    The invention provides the use of formoterol and budesonide in the treatment of chronic obstructive pulmonary disease.
    Patent expiration dates:
    • September 9, 2018
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      Patent use: USE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
  • Inhalation device
    Patent 7,967,011
    Issued: June 28, 2011
    Inventor(s): Hodson; Darren & Rasmussen; Jorgen
    Assignee(s): AstraZeneca AB
    Actuator for an inhaler for delivering medicament by inhalation, having a mouthpiece for guiding medicament to the mouth of a user; and a removable protection cap for the mouthpiece. The cap is secured to the mouthpiece by a cap retaining member that engages a mating recess in the mouthpiece outer periphery. The cap includes at least one release button arranged to provide an elastic deformation of the cap inner periphery that disengages the cap retaining member from the recess.
    Patent expiration dates:
    • August 11, 2021
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      Drug product
  • Composition for inhalation
    Patent 8,143,239
    Issued: March 27, 2012
    Inventor(s): Govind; Nayna & Marlow; Maria
    Assignee(s): AstraZeneca AB
    The invention relates to a formulation comprising formoterol and budesonide for use in the treatment of respiratory diseases. The composition further contains HFA 227, PVP and PEG, preferably PVP K25 and PEG 1000.
    Patent expiration dates:
    • January 29, 2023
      ✓ 
      Patent use: USE FOR THE TREATMENT OF ASTHMA AND COPD
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      Drug product
  • Inhaler cap strap
    Patent 8,387,615
    Issued: March 5, 2013
    Assignee(s): AstraZeneca AB
    An inhaler (1) for dispensing doses of medicament from a container under user activation said inhaling which comprises a body (7) which includes a mouthpiece (5) through which the medicament is dispensed and a cap (2) which can be place in a position to substantially occlude the mouthpiece (5). The cap (2) is attached to said body (7) by a strap (3) which pivots from said body (7), said cap (2) being arranged to slide on the strap (3) such that the cap (2) must translate away from the mouthpiece (5) prior to the pivoting of the strap (3).
    Patent expiration dates:
    • November 10, 2024
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      Drug product
  • Use for budesonide and formoterol
    Patent 8,461,211
    Issued: June 11, 2013
    Assignee(s): AstraZeneca AB
    The invention provides the use of formoterol and budesonide in the treatment of chronic obstructive pulmonary disease.
    Patent expiration dates:
    • September 9, 2018
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      Patent use: USE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
  • Inhaler device that reduces the risk for miscounting a dosage
    Patent 8,528,545
    Issued: September 10, 2013
    Assignee(s): AstraZeneca AB
    Inhaler device (10) comprising an actuator body (20) and an inhaler canister assembly (70), the inhaler canister assembly (70) is comprised of a canister (30) with a metering valve at a valve end and a dose counter unit (60) attached to a base end thereof. Further, the inhaler canister assembly (70) comprises first position ensuring means (110, 230), the actuator body comprises second position ensuring means (120,210), wherein the first and second position ensuring means being complementary mating means, and the first and second position ensuring means being so arranged that the inhaler device (10) cannot be fired, nor the counter unit (60) count unless the first and second position ensuring means are in a mating relationship. There is also provided an inhaler canister assembly (70) and an actuator body (20).
    Patent expiration dates:
    • October 16, 2028
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      Drug product
  • Composition for inhalation
    Patent 8,575,137
    Issued: November 5, 2013
    Assignee(s): AstraZeneca AB
    The invention relates to a formulation comprising formoterol and budesonide for use in the treatment of respiratory diseases. The composition further contains HFA 227, PVP and PEG, preferably PVP K25 and PEG 1000.
    Patent expiration dates:
    • January 29, 2023
      ✓ 
      Patent use: USE FOR THE TREATMENT OF ASTHMA AND COPD
      ✓ 
      Drug product
  • Inhalation device and a method for assembling said inhalation device
    Patent 8,616,196
    Issued: December 31, 2013
    Assignee(s): AstraZeneca AB
    An inhalation device for delivering doses of medicament to a user comprising: —a canister (5), said canister being adapted to accommodate the medicament to be dispensed to a user, and —a counter (15) which is connected to the canister (5). According to the invention —the canister (5) is adapted to receive the counter (15) on a base end (6a), —the counter and/or the canister further having contact parts (18, 20) for their attachment having means for increasing the friction and thereby allowing the counter to fixedly be attached onto the canister in a range of different positions in the lengthwise direction, —the counter further being adapted to during the process to assemble the counter to the canister, be urged onto the canister until the length of the counter and canister together is within a predefined tolerance of a predefined length.
    Patent expiration dates:
    • April 7, 2029
      ✓ 
      Drug product

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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