Question 1

Is there a generic for Pafolacianine sodium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Pafolacianine sodium?

Accepted Answer

CYTALUX (NDA 214907, ON TARGET LABS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Pafolacianine sodium?

Accepted Answer

The Orange Book lists 6 patents against Pafolacianine sodium products, with the earliest listed expiry in 2033. 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 Pafolacianine sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Pafolacianine sodium. 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 Pafolacianine sodium are approved?

Accepted Answer

Pafolacianine sodium is approved in the following dosage form: solution.

Patent	Expires	In	Type
9333270	Aug 26, 2033	in 7 yr 4 mo	SubstanceProductU-3291
10881747	Aug 26, 2033	in 7 yr 4 mo	SubstanceProductU-3291
9789208	Aug 26, 2033	in 7 yr 4 mo	SubstanceProductU-3291
9341629	Aug 26, 2033	in 7 yr 4 mo	SubstanceProduct
9254341	Oct 04, 2033	in 7 yr 5 mo	SubstanceProduct
9061057	Nov 29, 2035	in 9 yr 7 mo	SubstanceProductU-3291

Pafolacianine sodium

Brand (NDA) products · solution

Marketing exclusivity (2)

Listed patents (6)

Pafolacianine sodium — frequently asked questions

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