Generic Symbicort Availability
Last updated on Apr 10, 2025.
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)
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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)
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Manufacturer: ASTRAZENECA
Approval date: April 28, 2023
Strength(s): 0.16MG/INH;0.0048MG/INH [RLD]
Is there a generic version of Symbicort available?
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)
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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.
See also: Generic Drug FAQ.
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.
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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✓✓
- May 28, 2030
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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✓
- May 28, 2030
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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 circumstance 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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.