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SUFENTA PRESERVATIVE FREE

NDA

SUFENTANIL CITRATE | N019050 | RISING PHARMA HOLDINGS INC

1 strength0 unique patents0 unique exclusivities

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

5 trials from ClinicalTrials.gov — 4 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oliceridine vs Sufentanil for Cough During Anesthesia Induction NCT07660380	Phase 4	Not Yet Recruiting	Shiyou Wei	62	2026-06-22 → 2026-07-01
Propofol vs. Ciprofol for Anesthesia Induction in Frail Elderly Patients NCT07663695	N/A	Not Yet Recruiting	General Hospital of Ningxia Medical University	96	2026-06-25 → 2027-01-31
Fospropofol Disodium Versus Propofol for Patient Satisfaction in Ureteroscopy NCT07659132	Phase 4	Not Yet Recruiting	Shiyou Wei	190	2026-06-26 → 2026-09-26
Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Recovery in Patients Undergoing Major Abdominal Surgery NCT07651722	N/A	Recruiting	Tianjin First Central Hospital	132	2026-06-16 → 2026-09
Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.NCT04076748	Phase 3	Terminated	University Hospital, Bordeaux	115	2021-07-20 → 2024-07-21

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs3 inactive

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

VERANOVA LPSUFENTANIL CITRATE (GENERIC)

DMF 93991991

SPECGX LLCSUFENTANIL CITRATE USP

DMF 145051999

SPECGX LLCSUFENTANIL CITRATE USP/EP

DMF 309852016

JANSSEN PHARMACEUTICA NVInactiveSUFENTANIL CITRATE

DMF 113271995

CAMBREX CHARLES CITY INCInactiveSUFENTANIL

DMF 218212008

CAMBREX CHARLES CITY INCInactiveSUFENTANIL CITRATE

DMF 268002012

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 (1)

#001 — EQ 0.05MG BASE/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 4, 1984

No patent or exclusivity listings for this strength.