drug

(estradiol + norethindrone acetate + relugolix)

Marketedupdated 2mo ago

by Sumitomo Pharma America Inc

Approved

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Data sources

ClinicalTrials.gov

last refreshed 1h ago

Found something off?

Patent cliff

source: FDA Orange Book

first barrier falls

Jan 28, 2029

~2.6 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (8)

Nov 5, 2042formulationUS 12551447
May 3, 2038method-of-use (U-2360)US 11793812
Sep 29, 2037method-of-use (U-3129)US 11033551
Sep 29, 2037method-of-use (U-3129)US 11957684
Sep 27, 2033compositionUS 11795178
Sep 27, 2033compositionUS 12325714
Jan 28, 2029compositionUS 73009352.6y
Jan 28, 2026compositionUS 8058280

FDA exclusivities (1)

Jan 27, 2026M-289Method (3y)

Trials studying (estradiol + norethindrone acetate + relugolix)

phase4Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)withdrawn