Question 1

Is there a generic for Ozanimod hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ozanimod hydrochloride?

Accepted Answer

ZEPOSIA (NDA 209899, BRISTOL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Ozanimod hydrochloride?

Accepted Answer

The Orange Book lists 5 patents against Ozanimod hydrochloride 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 Ozanimod hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Ozanimod hydrochloride. 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 Ozanimod hydrochloride are approved?

Accepted Answer

Ozanimod hydrochloride is approved in the following dosage form: capsule.

Patent	Expires	In	Type
9382217	May 14, 2029	in 2 yr 11 mo	U-2774
8796318	May 14, 2029	in 2 yr 11 mo	SubstanceProduct
10239846	Nov 15, 2030	in 4 yr 6 mo	U-3740
8481573	Mar 24, 2033	in 6 yr 10 mo	SubstanceProductU-2774
11680050	Sep 30, 2038	in 12 yr 6 mo	SubstanceProductU-2774

Ozanimod hydrochloride

Brand (NDA) products · capsule

Marketing exclusivity (3)

Listed patents (5)

Ozanimod hydrochloride — frequently asked questions

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