Viewing data from:

ZAYNICH

NDA

CEFEPIME HYDROCHLORIDE; ZIDEBACTAM | N220787 | WOCKHARDT BIO AG

1 strength7 unique patents3 unique exclusivities

Patent Timeline

7 unique patents, 3 exclusivities by expiration date

Active (7)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Aug. 24, 2032

Aug. 24, 2032

Aug. 24, 2032

Aug. 24, 2032

Oct. 12, 2033

Aug. 24, 2032

Oct. 12, 2033

NCE

May. 29, 2031

GAIN

May. 29, 2036

NCE*GAIN

May. 29, 2036

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

1 letter from Drugs@FDA

Date	Submission	Document
Jun 2, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2GM BASE/VIAL;1GM/VIAL

RLD

7 patents3 exclusivities▴

POWDER;INTRAVENOUS | Approved: May 29, 2026

Patents (7) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8822450	Aug 24, 2032	—	Yes	Yes	—	—
8853197	Aug 24, 2032	—	Yes	—	—	—
9132133	Aug 24, 2032	—	—	—		—
9381200	Aug 24, 2032	—	—	Yes	—	—
9657021	Oct 12, 2033	—	Yes	—	—	—
9827235	Aug 24, 2032	—	—	Yes		—
9834557	Oct 12, 2033	—	Yes	—	—	—

Exclusivities (3)

Code	Date	Status
GAIN	May 29, 2036	Active
NCE	May 29, 2031	Active
NCE*GAINNewly listed — daily FDA feed, not yet in monthly Orange Book edition	May 29, 2036	Active

Change History (1)

Recent changes detected for this application.

ADDED8/31/2026

Wockhardt Bio AG obtained new chemical entity exclusivity for Zaynich (cefepime hydrochloride/zidebactam), extending regulatory protection until May 2036.

New: ZAYNICH (CEFEPIME HYDROCHLORIDE; ZIDEBACTAM) — exclusivity NCE*GAIN exp 05/29/2036