Question 1

Is there a generic for Imlunestrant tosylate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Imlunestrant tosylate?

Accepted Answer

INLURIYO (NDA 218881, ELI LILLY AND CO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Imlunestrant tosylate?

Accepted Answer

The Orange Book lists 2 patents against Imlunestrant tosylate products, with the earliest listed expiry in 2039. 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 Imlunestrant tosylate have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Imlunestrant tosylate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
11117902	Jul 11, 2039	in 13 yr 3 mo	SubstanceProductU-4278
10654866	Jul 11, 2039	in 13 yr 3 mo	SubstanceProductU-4278

Imlunestrant tosylate

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (2)

Imlunestrant tosylate — frequently asked questions

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