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PREVDUO

NDA

GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE | N216903 | AZURITY PHARMACEUTICALS INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2026

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Today

Oct. 25, 2038

Oct. 25, 2038

Oct. 25, 2038

Oct. 25, 2038

Oct. 25, 2038

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
Feb 24, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)

RLD

5 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 23, 2023

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10456354	Oct 25, 2038	—	—	Yes	—	—
11110054	Oct 25, 2038	—	—	Yes	—	—
11938217	Oct 25, 2038	—	—	Yes	—	—
12151020	Oct 25, 2038	—	—	Yes	—	—
12383491	Oct 25, 2038	—	—	Yes	—	—