Generic Symbicort Availability

Last updated on Jun 12, 2024.

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] ^[AB], 0.16MG/INH;0.0045MG/INH ^[RLD] ^[AB]

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

Manufacturer: ASTRAZENECA
Approval date: April 28, 2023
Strength(s): 0.16MG/INH;0.0048MG/INH ^[RLD]

Has a generic version of Symbicort been approved?

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

BREYNA (budesonide; formoterol fumarate dihydrate aerosol, metered;inhalation)

Manufacturer: MYLAN
Approval date: March 15, 2022
Strength(s): 0.08MG/INH;0.0045MG/INH ^[AB], 0.16MG/INH;0.0045MG/INH ^[AB]

Note: No generic formulation of the following product is available.

budesonide; formoterol fumarate - aerosol, metered;inhalation

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.

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.

Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems
Patent 10,716,753
Issued: July 21, 2020
Inventor(s): Vehring Reinhard & Hartman Michael Steven & Smith Adrian Edward & Joshi Vidya B. & Dwivedi Sarvajna Kumar
Assignee(s): Pearl Therapeutics, Inc.
Compositions, methods and systems are provided for pulmonary delivery of long-acting muscarinic antagonists and long-acting βadrenergic receptor agonists via a metered dose inhaler. In particular embodiments, the compositions include a suspension medium, active agent particles, and suspending particles, in which the active agent particles and suspending particles form a co-suspension within the suspension medium.
Patent expiration dates:
- May 28, 2030
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  Patent use: MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
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  Drug product
Patent 7,587,988
Patent expiration dates:
See Also
How much is Symbicort without insurance?AstraZeneca caps patient out-of-pocket costs at $35 per month for its US inhaled respiratory portfolio Symbicort and Price: Generic, Brand Name, and More 6 ways to save money on Symbicort
- April 10, 2026
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  Drug product
Patent 7587988*PED
Patent expiration dates:
- October 10, 2026
  ✓
  Pediatric exclusivity
Inhaler cap strap
Patent 8,387,615
Issued: March 5, 2013
Inventor(s): Bunce Martin
Assignee(s): AstraZeneca AB
An inhaler () for dispensing doses of medicament from a container under user activation said inhaling which comprises a body () which includes a mouthpiece () through which the medicament is dispensed and a cap () which can be place in a position to substantially occlude the mouthpiece (). The cap () is attached to said body () by a strap () which pivots from said body (), said cap () being arranged to slide on the strap () such that the cap () must translate away from the mouthpiece () prior to the pivoting of the strap ().
Patent expiration dates:
- March 26, 2027
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  Drug product
Inhaler cap strap
Patent 8387615*PED
Issued: March 5, 2013
Inventor(s): Bunce Martin
Assignee(s): AstraZeneca AB
An inhaler () for dispensing doses of medicament from a container under user activation said inhaling which comprises a body () which includes a mouthpiece () through which the medicament is dispensed and a cap () which can be place in a position to substantially occlude the mouthpiece (). The cap () is attached to said body () by a strap () which pivots from said body (), said cap () being arranged to slide on the strap () such that the cap () must translate away from the mouthpiece () prior to the pivoting of the strap ().
Patent expiration dates:
- September 26, 2027
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  Pediatric exclusivity
Inhaler device that reduces the risk for miscounting a dosage
Patent 8,528,545
Issued: September 10, 2013
Inventor(s): Hodson Darren & Treneman William
Assignee(s): AstraZeneca AB
Inhaler device () comprising an actuator body () and an inhaler canister assembly (), the inhaler canister assembly () is comprised of a canister () with a metering valve at a valve end and a dose counter unit () attached to a base end thereof. Further, the inhaler canister assembly () comprises first position ensuring means (), the actuator body comprises second position ensuring means (), 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 () cannot be fired, nor the counter unit () count unless the first and second position ensuring means are in a mating relationship. There is also provided an inhaler canister assembly () and an actuator body ().
Patent expiration dates:
See Also
Symbicort: 7 things you should know - Drugs.com
- October 16, 2028
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  Drug product
Inhaler device that reduces the risk for miscounting a dosage
Patent 8528545*PED
Issued: September 10, 2013
Inventor(s): Hodson Darren & Treneman William
Assignee(s): AstraZeneca AB
Inhaler device () comprising an actuator body () and an inhaler canister assembly (), the inhaler canister assembly () is comprised of a canister () with a metering valve at a valve end and a dose counter unit () attached to a base end thereof. Further, the inhaler canister assembly () comprises first position ensuring means (), the actuator body comprises second position ensuring means (), 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 () cannot be fired, nor the counter unit () count unless the first and second position ensuring means are in a mating relationship. There is also provided an inhaler canister assembly () and an actuator body ().
Patent expiration dates:
- April 16, 2029
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  Pediatric exclusivity
Inhalation device and a method for assembling said inhalation device
Patent 8,616,196
Issued: December 31, 2013
Inventor(s): Hodson Darren & Treneman William
Assignee(s): AstraZeneca AB
An inhalation device for delivering doses of medicament to a user comprising: —a canister (), said canister being adapted to accommodate the medicament to be dispensed to a user, and —a counter () which is connected to the canister (). According to the invention —the canister () is adapted to receive the counter () on a base end (), —the counter and/or the canister further having contact parts () 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
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  Drug product
Inhalation device and a method for assembling said inhalation device
Patent 8616196*PED
Issued: December 31, 2013
Inventor(s): Hodson Darren & Treneman William
Assignee(s): AstraZeneca AB
An inhalation device for delivering doses of medicament to a user comprising: —a canister (), said canister being adapted to accommodate the medicament to be dispensed to a user, and —a counter () which is connected to the canister (). According to the invention —the canister () is adapted to receive the counter () on a base end (), —the counter and/or the canister further having contact parts () 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:
- October 7, 2029
  ✓
  Pediatric exclusivity
Inhaler cap strap
Patent 8,875,699
Issued: November 4, 2014
Inventor(s): Bunce Martin
Assignee(s): AstraZeneca AB
An inhaler () for dispensing doses of medicament from a container under user activation includes a body () which includes a mouthpiece () through which the medicament is dispensed and a cap () which can be place in a position to substantially occlude the mouthpiece (). The cap () is attached to the body () by a strap () which pivots from the body (), the cap () being arranged to slide on the strap () such that the cap () must translate away from the mouthpiece () prior to the pivoting of the strap ().
Patent expiration dates:
- November 10, 2024
  ✓
  Drug product
Inhaler cap strap
Patent 8875699*PED
Issued: November 4, 2014
Inventor(s): Bunce Martin
Assignee(s): AstraZeneca AB
An inhaler () for dispensing doses of medicament from a container under user activation includes a body () which includes a mouthpiece () through which the medicament is dispensed and a cap () which can be place in a position to substantially occlude the mouthpiece (). The cap () is attached to the body () by a strap () which pivots from the body (), the cap () being arranged to slide on the strap () such that the cap () must translate away from the mouthpiece () prior to the pivoting of the strap ().
Patent expiration dates:
- May 10, 2025
  ✓
  Pediatric exclusivity
Compositions, methods and systems for respiratory delivery of two or more active agents
Patent 9,415,009
Issued: August 16, 2016
Inventor(s): Vehring Reinhard & Hartman Michael Steven & Lechuga-Ballesteros David & Smith Adrian Edward & Joshi Vidya B. & Dwivedi Sarvajna Kumar
Assignee(s): Pearl Therapeutics, Inc.
Compositions, methods and systems are provided for pulmonary or nasal delivery of two or more active agents via a metered dose inhaler. In one embodiment, the compositions include a suspension medium, active agent particles, and suspending particles, in which the active agent particles and suspending particles form a co-suspension within the suspension medium.
Patent expiration dates:
- May 28, 2030
  ✓
  Patent use: MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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Glossary

Term	Definition
Drug Patent	A 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 Exclusivity	Exclusivity 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 circ*mstance of the exclusivity grant.
RLD	A 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.
AB	Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

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Generic Symbicort Availability - Drugs.com (2024)