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What's the generic version of Symbicort?

2 min read

In March 2022, the FDA approved the first generic version of Symbicort, providing more affordable options for patients with asthma and COPD. The generic version of Symbicort is called budesonide-formoterol and is available as both an authorized generic and another branded generic, Breyna.

Quick Summary

Budesonide-formoterol is the generic version of Symbicort, with versions including Breyna and an authorized generic. These alternatives are bioequivalent, providing the same treatment efficacy and safety profile for asthma and COPD, often at a lower cost.

Key Points

  • Generic Name: The generic version of Symbicort is budesonide-formoterol.

  • Generic Brands: The generic is available as an authorized generic (same manufacturer) and a standard generic called Breyna (different manufacturer).

  • FDA Approved: All generic versions are FDA-approved and bioequivalent, meaning they are proven to be as safe and effective as brand-name Symbicort.

  • Cost Savings: Generic versions are typically more affordable, especially for those without insurance, with prices varying by pharmacy and insurance coverage.

  • Not a Rescue Inhaler: Like Symbicort, the generic versions are for long-term maintenance and should not be used for sudden, severe symptoms.

  • Same Active Ingredients: Both brand and generic versions contain the same active ingredients, budesonide (steroid) and formoterol (LABA), to reduce inflammation and relax airways.

  • Rinse After Use: Rinsing the mouth with water after each use helps prevent oral thrush, a potential side effect of the inhaled corticosteroid.

In This Article

Symbicort is a prescription medication used for the long-term maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It contains a combination of two active ingredients: budesonide, an inhaled corticosteroid that reduces inflammation, and formoterol, a long-acting beta-agonist (LABA) that relaxes the airway muscles. As with many brand-name medications, generic versions of Symbicort have become available, offering patients more affordable treatment options.

The Generic Versions of Symbicort

There are two main types of generic versions available for Symbicort: an authorized generic and a standard Abbreviated New Drug Application (ANDA) generic. Both are FDA-approved, ensuring they meet the same strict standards for safety and effectiveness as the original brand-name drug.

Authorized Generic (Budesonide-Formoterol)

An authorized generic is produced by the same manufacturer as the brand-name drug or a partner. It is the exact same drug product as brand-name Symbicort but is labeled with the generic name 'budesonide-formoterol'. AstraZeneca launched an authorized generic through a partner, Prasco.

Standard Generic (Breyna)

Breyna is a standard generic produced by Viatris (formerly Mylan). It contains the same active ingredients (budesonide and formoterol) in the same strength and dosage form as Symbicort. It is bioequivalent to Symbicort, meaning it works the same way and produces the same therapeutic effect, although there might be minor differences in inactive ingredients or the inhaler design.

Comparing Brand-Name and Generic Symbicort

Feature Brand-Name Symbicort Authorized Generic (Budesonide-Formoterol) Standard Generic (Breyna)
Active Ingredients Budesonide and Formoterol Budesonide and Formoterol Budesonide and Formoterol
Manufacturer AstraZeneca Prasco (in partnership with AstraZeneca) Viatris (formerly Mylan)
FDA Approval Yes Yes (by reference to brand) Yes (March 2022)
Bioequivalence N/A Yes, identical Yes
Delivery System Metered-dose inhaler (pMDI) Metered-dose inhaler (pMDI), identical to brand Metered-dose inhaler (pMDI), may feel different
Cost Highest (without insurance) Lower than brand-name Often the lowest cost option
Inactive Ingredients As per brand formula Identical to brand formula May vary slightly

Is generic Symbicort as effective?

Yes, generic Symbicort is considered just as safe and effective as the brand-name version. The FDA requires generic medications to be bioequivalent, delivering the same amount of active ingredients for the same therapeutic effect. While Breyna's inhaler may feel different, the medication delivery is calibrated to be therapeutically equivalent.

Important considerations when switching to a generic

  • Insurance Coverage: Check with your insurance provider about coverage for specific generic versions and associated costs.
  • Allergies: If you have allergies to inactive ingredients like dyes or preservatives, confirm the generic formulation is safe with your pharmacist.
  • Proper Technique: Proper inhaler technique is vital for correct dosing. Ask your pharmacist for a demonstration of your specific device.

Conclusion

Generic budesonide-formoterol, including the authorized generic and Breyna, offers cost-effective alternatives to brand-name Symbicort for asthma and COPD. These FDA-approved generics are therapeutically equivalent, providing the same standard of care. Discuss options with your doctor and pharmacist to find the most suitable and affordable version. The FDA provides resources on generic drug equivalence for more information.

Frequently Asked Questions

The generic name for Symbicort is budesonide-formoterol.

Yes, there are generic versions of Symbicort available, including an authorized generic called budesonide-formoterol and a standard generic called Breyna.

Yes, generic versions of Symbicort are FDA-approved as bioequivalent, meaning they are considered just as safe and effective as the brand-name medication.

Generic versions are typically less expensive than brand-name Symbicort. The actual price can vary widely based on your insurance plan, pharmacy, and available discount programs.

The active ingredients in both are the same, but Breyna is manufactured by a different company and uses a slightly different inhaler device. Both are considered therapeutically equivalent.

Yes, most people can easily switch from brand-name Symbicort to a generic version, but you should always consult your healthcare provider before making any changes to your medication.

Yes, the side effect profiles of generic versions are expected to be the same as brand-name Symbicort because they contain the same active ingredients. Common side effects can include throat irritation, headache, and oral thrush.

In many cases, a new prescription is not needed, as pharmacists can often substitute a generic for the brand-name drug. However, for a different brand like Breyna, your doctor may need to write a new prescription to ensure proper coverage and dosage.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.