Question 1

Is there a generic for Albuterol sulfate; budesonide?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Albuterol sulfate; budesonide. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Albuterol sulfate; budesonide?

Accepted Answer

AIRSUPRA (NDA 214070, ASTRAZENECA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Albuterol sulfate; budesonide?

Accepted Answer

The Orange Book lists 1 patent against Albuterol sulfate; budesonide products, with the earliest listed expiry in 2030. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Albuterol sulfate; budesonide have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Albuterol sulfate; budesonide. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Albuterol sulfate; budesonide are approved?

Accepted Answer

Albuterol sulfate; budesonide is approved in the following dosage form: aerosol, metered.

Albuterol sulfate; budesonide

Brand (NDA) products · aerosol, metered

Marketing exclusivity (2)

Listed patents (1)

Albuterol sulfate; budesonide — frequently asked questions

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