Question 1

Is there a generic for Ritlecitinib tosylate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ritlecitinib tosylate?

Accepted Answer

LITFULO (NDA 215830, 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 Ritlecitinib tosylate?

Accepted Answer

The Orange Book lists 3 patents against Ritlecitinib tosylate 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 Ritlecitinib tosylate have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Ritlecitinib tosylate is approved in the following dosage form: capsule.

Patent	Expires	In	Type
12077533	Dec 03, 2034	in 8 yr 7 mo	U-3994
9617258	Dec 03, 2034	in 8 yr 7 mo	SubstanceProduct
12116368	Oct 17, 2041	in 15 yr 7 mo	Substance

Ritlecitinib tosylate

Brand (NDA) products · capsule

Marketing exclusivity (1)

Listed patents (3)

Ritlecitinib tosylate — frequently asked questions

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