Question 1

Is there a generic for Elacestrant hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Elacestrant hydrochloride?

Accepted Answer

ORSERDU (NDA 217639, STEMLINE THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Elacestrant hydrochloride?

Accepted Answer

The Orange Book lists 7 patents against Elacestrant hydrochloride 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 Elacestrant hydrochloride have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Elacestrant hydrochloride is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7612114	Aug 18, 2026	in 2 mo	SubstanceProductU-3523
10071066	Oct 10, 2034	in 8 yr 5 mo	U-3524
11779552	Oct 10, 2034	in 8 yr 5 mo	U-3524
10420734	Oct 03, 2036	in 10 yr 5 mo	U-3524
11819480	Feb 28, 2037	in 10 yr 10 mo	U-3523
10745343	Jan 05, 2038	in 11 yr 9 mo	U-3523
10385008	Jan 05, 2038	in 11 yr 9 mo	SubstanceProduct

Elacestrant hydrochloride

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (7)

Elacestrant hydrochloride — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.