Question 1

Is there a generic for Sulfur hexafluoride lipid-type a microspheres?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Sulfur hexafluoride lipid-type a microspheres. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Sulfur hexafluoride lipid-type a microspheres?

Accepted Answer

LUMASON (NDA 203684, BRACCO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sulfur hexafluoride lipid-type a microspheres?

Accepted Answer

The Orange Book lists 3 patents against Sulfur hexafluoride lipid-type a microspheres products, with the earliest listed expiry in 2038. 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

What dosage forms of Sulfur hexafluoride lipid-type a microspheres are approved?

Accepted Answer

Sulfur hexafluoride lipid-type a microspheres is approved in the following dosage form: for suspension.

Patent	Expires	In	Type
10232061	Jul 06, 2038	in 12 yr 3 mo	Product
10335502	Jul 06, 2038	in 12 yr 3 mo	Product
11723869	May 15, 2039	in 13 yr 1 mo	ProductU-3666

Sulfur hexafluoride lipid-type a microspheres

Brand (NDA) products · for suspension

Listed patents (3)

Sulfur hexafluoride lipid-type a microspheres — frequently asked questions

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