Question 1

Is there a generic for Umbralisib tosylate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Umbralisib tosylate?

Accepted Answer

UKONIQ (NDA 213176, TG THERAPS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Umbralisib tosylate?

Accepted Answer

The Orange Book lists 8 patents against Umbralisib tosylate 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 Umbralisib tosylate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Umbralisib tosylate. 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 Umbralisib tosylate are approved?

Accepted Answer

Umbralisib tosylate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
10072013	Jul 02, 2033	in 7 yr 2 mo	U-3063
10570142	Jul 02, 2033	in 7 yr 2 mo	SubstanceProductU-3064
9669033	Jul 02, 2033	in 7 yr 2 mo	U-3063
10981919	Jul 02, 2033	in 7 yr 2 mo	U-3063
9150579	Jul 02, 2033	in 7 yr 2 mo	SubstanceProduct
9969740	May 26, 2035	in 9 yr 1 mo	SubstanceProductU-3064
10414773	May 26, 2035	in 9 yr 1 mo	SubstanceProductU-3063
10947244	May 26, 2035	in 9 yr 1 mo	U-3063

Umbralisib tosylate

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (8)

Umbralisib tosylate — frequently asked questions

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