Question 1

Is there a generic for Abrocitinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Abrocitinib?

Accepted Answer

CIBINQO (NDA 213871, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Abrocitinib?

Accepted Answer

The Orange Book lists 3 patents against Abrocitinib products, with the earliest listed expiry in 2034. 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 Abrocitinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Abrocitinib. 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 Abrocitinib are approved?

Accepted Answer

Abrocitinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9549929	Feb 19, 2034	in 7 yr 9 mo	U-3195
9545405	Feb 19, 2034	in 7 yr 9 mo	SubstanceProduct
9035074	Jan 14, 2036	in 9 yr 9 mo	SubstanceProduct

Abrocitinib

Brand (NDA) products · tablet

Marketing exclusivity (6)

Listed patents (3)

Abrocitinib — frequently asked questions

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