Question 1

Is there a generic for Deuruxolitinib phosphate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Deuruxolitinib phosphate?

Accepted Answer

LEQSELVI (NDA 217900, SUN PHARM INDS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Deuruxolitinib phosphate?

Accepted Answer

The Orange Book lists 6 patents against Deuruxolitinib phosphate products, with the earliest listed expiry in 2037. 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 Deuruxolitinib phosphate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Deuruxolitinib phosphate. 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 Deuruxolitinib phosphate are approved?

Accepted Answer

Deuruxolitinib phosphate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
10561659	May 04, 2037	in 11 yr	U-3976
12076323	May 04, 2037	in 11 yr	U-3976
11919907	May 21, 2041	in 15 yr 2 mo	ProductU-3976
12285432	Aug 11, 2042	in 16 yr 5 mo	U-3976
12247034	May 10, 2044	in 18 yr 2 mo	SubstanceProduct
12364699	Oct 10, 2044	in 18 yr 7 mo	U-3976

Deuruxolitinib phosphate

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (6)

Deuruxolitinib phosphate — frequently asked questions

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