Question 1

Is there a generic for Etripamil?

Accepted Answer

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

Question 2

What is the reference-listed drug for Etripamil?

Accepted Answer

CARDAMYST (NDA 218571, MILESTONE PHARMS USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Etripamil?

Accepted Answer

The Orange Book lists 6 patents against Etripamil products, with the earliest listed expiry in 2028. 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 Etripamil have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Etripamil is approved in the following dosage form: spray.

Patent	Expires	In	Type
10010522	Jun 19, 2028	in 2 yr	U-38
9463179	Jun 19, 2028	in 2 yr	U-4370
10010523	Jun 19, 2028	in 2 yr	Substance
9227918	Jun 19, 2028	in 2 yr	Product
10117848	Apr 13, 2036	in 10 yr	ProductU-4370
12257224	Jul 15, 2042	in 16 yr 4 mo	U-4370

Etripamil

Brand (NDA) products · spray

Marketing exclusivity (1)

Listed patents (6)

Etripamil — frequently asked questions

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