Question 1

Is there a generic for Ponesimod?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ponesimod?

Accepted Answer

PONVORY (NDA 213498, VANDA PHARMS 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 Ponesimod?

Accepted Answer

The Orange Book lists 5 patents against Ponesimod products, with the earliest listed expiry in 2029. 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 Ponesimod have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 10 marketing-exclusivity periods for Ponesimod. 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 Ponesimod are approved?

Accepted Answer

Ponesimod is approved in the following dosage form: tablet.

Patent	Expires	In	Type
RE43728	Nov 16, 2029	in 3 yr 6 mo	SubstanceProduct
9062014	May 06, 2032	in 6 yr	SubstanceProductU-2774
12336980	Dec 10, 2035	in 9 yr 7 mo	U-3103
10220023	Dec 10, 2035	in 9 yr 7 mo	U-3103
11951097	Oct 10, 2042	in 16 yr 7 mo	U-3891

Ponesimod

Brand (NDA) products · tablet

Marketing exclusivity (10)

Listed patents (5)

Ponesimod — frequently asked questions

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