Question 1

Is there a generic for Imetelstat sodium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Imetelstat sodium?

Accepted Answer

RYTELO (NDA 217779, GERON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Imetelstat sodium?

Accepted Answer

The Orange Book lists 6 patents against Imetelstat sodium products, with the earliest listed expiry in 2026. 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 Imetelstat sodium have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Imetelstat sodium is approved in the following dosage form: powder.

Patent	Expires	In	Type
9388416	Sep 09, 2026	in 3 mo	U-3956
9388415	Sep 09, 2026	in 3 mo	U-3956
7494982	Dec 27, 2026	in 6 mo	SubstanceProduct
12442000	Mar 15, 2033	in 6 yr 10 mo	U-3956
9375485	Mar 15, 2033	in 6 yr 10 mo	U-3956
12171778	Jun 16, 2039	in 13 yr 2 mo	U-3956

Imetelstat sodium

Brand (NDA) products · powder

Marketing exclusivity (2)

Listed patents (6)

Imetelstat sodium — frequently asked questions

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