Viewing data from:

ZURZUVAE

NDA

ZURANOLONE | N217369 | BIOGEN INC

3 strengths5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

Apr. 17, 2034

Apr. 17, 2034

Apr. 17, 2034

Aug. 23, 2037

Aug. 23, 2037

NCE

Oct. 31, 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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 21, 2026	SUPPL -3	View Letter (PDF)
Aug 2, 2024	SUPPL -1	View Letter (PDF)
Aug 8, 2023	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 20MG

RLD

5 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Oct 31, 2023

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9512165	Apr 17, 2034	—	Yes	Yes	—	—
10172871	Apr 17, 2034	—	—	—		—
10342810	Apr 17, 2034	—	—	—		—
11236121	Aug 23, 2037	—	Yes	—	—	—
11884696	Aug 23, 2037	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Oct 31, 2028	Active

#002 — 25MG

RLD

5 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Oct 31, 2023

#003 — 30MG

RLD

5 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Oct 31, 2023

Change History (3)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Biogen Inc. updated its company name to Biogen for ZURZUVAE (zuranolone) NDA 217369.

Old: BIOGEN INC

New: BIOGEN

MODIFIEDApplicant7/1/2026

Biogen Inc updated its corporate name to Biogen for ZURZUVAE (zuranolone) NDA 217369.

Old: BIOGEN INC

New: BIOGEN

MODIFIEDApplicant7/1/2026

Biogen Inc. updated its corporate name to Biogen in the FDA Orange Book entry for Zurzuvae (zuranolone), NDA 217369.

Old: BIOGEN INC

New: BIOGEN