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NDA

DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM | N216974 | ENTASIS THERAPEUTICS INC

1 strength4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Active (4)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Apr. 2, 2033

Apr. 2, 2033

Nov. 17, 2035

Nov. 17, 2035

NCE

May. 23, 2028

GAIN

May. 23, 2033

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
May 25, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL

RLD

4 patents2 exclusivities▴

POWDER;INTRAVENOUS | Approved: May 23, 2023

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9309245	Apr 2, 2033	—	Yes	—	—	—
9623014	Apr 2, 2033	—	—	—		—
9968593	Nov 17, 2035	—	—	Yes		—
10376499	Nov 17, 2035	—	—	Yes		—

Exclusivities (2)

Code	Date	Status
GAIN	May 23, 2033	Active
NCE	May 23, 2028	Active