Question 1

Is there a generic for Elamipretide hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Elamipretide hydrochloride?

Accepted Answer

FORZINITY (NDA 215244, STEALTH BIOTHERAPS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Elamipretide hydrochloride?

Accepted Answer

The Orange Book lists 6 patents against Elamipretide hydrochloride products, with the earliest listed expiry in 2027. 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 Elamipretide hydrochloride have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Elamipretide hydrochloride is approved in the following dosage form: solution.

Patent	Expires	In	Type
7576061	Jan 20, 2027	in 7 mo	SubstanceProduct
12268724	Feb 28, 2034	in 7 yr 10 mo	U-4277
11771734	Feb 28, 2034	in 7 yr 10 mo	U-4277
11083772	Feb 28, 2034	in 7 yr 10 mo	U-4277
11083771	Feb 28, 2034	in 7 yr 10 mo	U-4277
9687519	Feb 28, 2034	in 7 yr 10 mo	U-4277

Elamipretide hydrochloride

Brand (NDA) products · solution

Marketing exclusivity (2)

Listed patents (6)

Elamipretide hydrochloride — frequently asked questions

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