Viewing data from:

ORSERDU

NDA

ELACESTRANT HYDROCHLORIDE | N217639 | STEMLINE THERAPEUTICS INC

2 strengths7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

Aug. 18, 2026

Oct. 10, 2034

Jan. 5, 2038

Oct. 3, 2036

Jan. 5, 2038

Oct. 10, 2034

Feb. 28, 2037

NCE

Jan. 27, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Orserdu (2023)

Total Spending

$127.6M

Total Claims

5,746

Beneficiaries

1,640

Avg Cost/Unit

$694.68

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 26, 2026	SUPPL -7	View Letter (PDF)
Nov 14, 2023	SUPPL -1	View Letter (PDF)
Feb 2, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 86MG BASE

RLD

7 patents1 exclusivity▴

TABLET;ORAL | Approved: Jan 27, 2023

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7612114	Aug 18, 2026	—	Yes	Yes		—
10071066	Oct 10, 2034	—	—	—		—
10385008	Jan 5, 2038	—	Yes	Yes	—	—
10420734	Oct 3, 2036	—	—	—		—
10745343	Jan 5, 2038	—	—	—		—
11779552	Oct 10, 2034	—	—	—		—
11819480	Feb 28, 2037	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Jan 27, 2028	Active

#002 — EQ 345MG BASE

RLD

7 patents1 exclusivity▾

TABLET;ORAL | Approved: Jan 27, 2023