Breyna™ – The First FDA Approved Symbicort® Generic With a 0.1 Gram Problem

Breyna™, like Symbicort® is approved as a maintenance therapy for people with COPD and for asthma patients ages 6 and older. For Breyna™ to become a regular generic, the manufacturer (Viatris) had to submit an Abbreviated New Drug Application (ANDA) to the FDA. Viatris had to prove that Breyna™ is comparable to Symbicort® in dosage form, strength, route, quality, performance characteristics, and intended use. Below is a chart comparing Symbicort®, its authorized generic and the new “regular” generic Breyna™ (also known as an ANDA generic).

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Product NDC Labeler FDA Application Number Package

Size (gm)

Symbicort® 80-4.5 MCG 00186-0372-20 AstraZeneca 021929 10.2 Brand
Budesonide-Formoterol Fumarate 80-4.5 MCG 00310-7372-20 Prasco 021929 10.2 Authorized Generic
Breyna™ 80-4.5 MCG 00378-7502-32 Mylan 211699 10.3 ANDA Generic
Symbicort® 160-4.5 MCG 00186-0370-20 AstraZeneca 021929 10.2 Brand
Budesonide-Formoterol Fumarate 160-4.5 MCG 00310-7370-20 Prasco 021929 10.2 Authorized Generic
Breyna™ 160-4.5 MCG 00378-7503-32 Mylan 211699 10.3 ANDA Generic

PAAS Tips:

  • The Breyna™ inhaler comes in a package size of 10.3 gm, which is different than Symbicort® and its authorized generic that come in a package size of 10.2 gm
    • PAAS would recommend the pharmacy obtain a new prescription for Breyna™ due to the different package sizing. If a prescriber writes for Symbicort® 10.2 gm, one inhaler with 5 refills, a total of 61.2 gm was authorized. If a pharmacy bills and dispenses all 6 fills using the Breyna™ NDC, this would be 61.8 gm total. If audited, a PBM could recoup the last claim due to dispensing an overbilled quantity that was not authorized.
  • See our updated Inhaler Chart on the PAAS Portal
  • What is an Authorized Generic?
    • An authorized generic is the exact same drug product as the brand, including both active and inactive ingredients
    • It is often made in the same facility and on the same equipment as the brand with the generic name on the label instead of the brand name, and sold at a lower price
    • Note that the FDA approval numbers are the same for the brand and the authorized generic
    • Considered to be therapeutically equivalent to its brand-name drug because it is the same drug
  • What is a Regular Generic (ANDA)?
    • An ANDA generic is the same brand-name drug in active ingredients, conditions of use, dosage form, strength, route and for the most part labeling, but may have certain minor differences such as inactive ingredients
    • Typically developed and made by a company other than the company that makes the brand-name drug.
    • Has a different FDA application number than the brand name and authorized generic
    • Must confirm bioequivalence to the brand name
  • See the FDA website for additional discussion on Authorized Generics

Jennifer Ottman, CPhT