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).
|Product||NDC||Labeler||FDA Application Number||Package
|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|
- 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
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