Viewing data from:

LYNKUET

NDA

ELINZANETANT | N219469 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

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2045

2046

Today

Sep. 15, 2027

May. 18, 2036

Mar. 13, 2039

Mar. 13, 2039

Mar. 13, 2039

May. 14, 2045

NCE

Oct. 24, 2030

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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer NCT05587296	Phase 3	Active	Bayer	474	2022-10-14 → 2028-06-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 28, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG

RLD

6 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Oct 24, 2025

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7683056	Sep 15, 2027	—	Yes	Yes	—	—
10195205	May 18, 2036	—	—	—		—
10774091	Mar 13, 2039	—	—	Yes	—	—
11787820	Mar 13, 2039	—	—	—		—
12264164	Mar 13, 2039	—	—	—		—
12533358	May 14, 2045	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Oct 24, 2030	Active

Change History (1)

Recent changes detected for this application.

MODIFIEDPatent Expiration7/1/2026

Bayer Healthcare's patent 7683056 for LYNKUET (elinzanetant) listed in Orange Book NDA 219469 now expires Sep 2027, extended one year from its previous Sep 2026 expiration date.

Old: Sep 15, 2026

New: Sep 15, 2027