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ORLYNVAH

NDA

PROBENECID; SULOPENEM ETZADROXIL | N213972 | ITERUM THERAPEUTICS US LTD

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

Jun. 3, 2029

Dec. 23, 2039

Apr. 1, 2039

Apr. 1, 2039

Dec. 23, 2039

NCE

Oct. 25, 2029

GAIN

Oct. 25, 2034

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
Dec 31, 2025	SUPPL -2	View Letter (PDF)
Mar 25, 2025	SUPPL -1	View Letter (PDF)
Oct 28, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG;500MG

RLD

5 patents2 exclusivities▴

TABLET;ORAL | Approved: Oct 25, 2024

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7795243	Jun 3, 2029	—	Yes	Yes	—
11478428	Dec 23, 2039	—	—	Yes	—
11554112	Apr 1, 2039	—	—	—	—
12109197	Apr 1, 2039	—	—	—	—
12544337	Dec 23, 2039	—	—	Yes	—

Exclusivities (2)

Code	Date	Status
GAIN	Oct 25, 2034	Active
NCE	Oct 25, 2029	Active