Question 1

Is there a generic for Casimersen?

Accepted Answer

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

Question 2

What is the reference-listed drug for Casimersen?

Accepted Answer

AMONDYS 45 (NDA 213026, SAREPTA THERAPS 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 Casimersen?

Accepted Answer

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

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Casimersen. 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 Casimersen are approved?

Accepted Answer

Casimersen is approved in the following dosage form: solution.

Patent	Expires	In	Type
RE48960	Feb 16, 2029	in 2 yr 8 mo	SubstanceProductU-3087
9758783	Nov 12, 2030	in 4 yr 6 mo	U-3088
10781450	Nov 12, 2030	in 4 yr 6 mo	U-3089
10287586	Nov 12, 2030	in 4 yr 6 mo	SubstanceProduct
9228187	Nov 12, 2030	in 4 yr 6 mo	SubstanceProduct

Casimersen

Brand (NDA) products · solution

Marketing exclusivity (2)

Listed patents (5)

Casimersen — frequently asked questions

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