Question 1

Is there a generic for Budesonide; formoterol fumarate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Budesonide; formoterol fumarate?

Accepted Answer

SYMBICORT AEROSPHERE (NDA 216579, 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 Budesonide; formoterol fumarate?

Accepted Answer

The Orange Book lists 2 patents against Budesonide; formoterol fumarate 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 Budesonide; formoterol fumarate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Budesonide; formoterol fumarate. 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 Budesonide; formoterol fumarate are approved?

Accepted Answer

Budesonide; formoterol fumarate is approved in the following dosage form: aerosol, metered.

Patent	Expires	In	Type
9415009	May 28, 2030	in 4 yr	U-4513
10716753	May 28, 2030	in 4 yr	ProductU-4513

Budesonide; formoterol fumarate

Brand (NDA) products · aerosol, metered

Marketing exclusivity (2)

Listed patents (2)

Budesonide; formoterol fumarate — frequently asked questions

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