Viewing data from:

DORAL

NDA

QUAZEPAM | N018708 | GALT PHARMACEUTICALS LLC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

Jun. 3, 2028

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TATEYAMA KASEI CO LTDQUAZEPAM

DMF 150312000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Dec 27, 1985

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7608616	Jun 3, 2028	—	—	—		—

#003 — 7.5MG

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Feb 26, 1987