Question 1

Is there a generic for Xenon xe-129 hyperpolarized?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Xenon xe-129 hyperpolarized. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Xenon xe-129 hyperpolarized?

Accepted Answer

XENOVIEW (NDA 214375, POLAREAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Xenon xe-129 hyperpolarized?

Accepted Answer

The Orange Book lists 2 patents against Xenon xe-129 hyperpolarized products, with the earliest listed expiry in 2035. 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 Xenon xe-129 hyperpolarized have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Xenon xe-129 hyperpolarized. 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 Xenon xe-129 hyperpolarized are approved?

Accepted Answer

Xenon xe-129 hyperpolarized is approved in the following dosage form: gas.

Patent	Expires	In	Type
10583205	Feb 20, 2035	in 8 yr 10 mo	Product
11052161	Dec 29, 2035	in 9 yr 8 mo	Product

Xenon xe-129 hyperpolarized

Brand (NDA) products · gas

Marketing exclusivity (1)

Listed patents (2)

Xenon xe-129 hyperpolarized — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.