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NUZOLVENCE

NDA

ZOLIFLODACIN | N219491 | ENTASIS THERAPEUTICS INC

1 strength6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 2 exclusivities by expiration date

Active (6)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Jun. 20, 2030

Jan. 21, 2034

Oct. 13, 2029

Jan. 21, 2034

Jan. 21, 2034

Jan. 21, 2034

NCE

Dec. 12, 2030

GAIN

Dec. 12, 2035

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
Dec 15, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3GM/PACKET

RLD

6 patents2 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Dec 12, 2025

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8658641	Jun 20, 2030	—	Yes	—	—	—
8889671	Jan 21, 2034	—	Yes	—		—
9040528	Oct 13, 2029	—	—	—		—
9187495	Jan 21, 2034	—	Yes	—		—
9540394	Jan 21, 2034	—	—	—		—
9839641	Jan 21, 2034	—	—	—		—

Exclusivities (2)

Code	Date	Status
GAIN	Dec 12, 2035	Active
NCE	Dec 12, 2030	Active