Viewing data from:

FENTANYL CITRATE

NDA

FENTANYL CITRATE | N215870 | EXELA PHARMA SCIENCES LLC

2 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-0805 · 4 docket documents Law firm Hyman, Phelps & McNamara, P.C. filed this petition requesting that the FDA determine whether Fentanyl Citrate Injection in two strengths approved under NDA 215870 by Exela Pharma Sciences, LLC was voluntarily withdrawn for safety or effectiveness reasons under sections 505(j) and 505(w) of	505(q)	2024-02-14	Granted	Hyman, Phelps & McNamara, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

404 trials from ClinicalTrials.gov — 3 recruiting, 4 active, 269 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery NCT03214510	Phase 3	Active	M.D. Anderson Cancer Center	101	2017-10-04 → 2026-07-31
CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)NCT03167905	Phase 2/3	Active	KK Women's and Children's Hospital	881	2017-06-15 → 2026-12-31
Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients NCT04188418	Phase 3	Active	M.D. Anderson Cancer Center	150	2020-10-23 → 2027-08-31
Comparison of Regimens MPIB, CIPCEA, PCEA NCT02278601	Phase 3	Active	KK Women's and Children's Hospital	839	2015-01-28 → 2026-12-31
Dose-response Study of Spinally Administered Ropivacaine for Caesarean Section in Tall Parturients NCT03936790	N/A	By Invitation	Paraskevi Matsota	40	2019-06-02 → 2025-11
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients NCT03401593	N/A	Not Yet Recruiting	Yonsei University	135	2019-10 → 2028-06
Premedication for Less Invasive Surfactant Administration NCT03735563	Phase 4	Recruiting	University of Oulu	40	2019-02-11 → 2026-10-31
Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy NCT04128540	Phase 3	Completed	Cairo University	28	2020-02-01 → 2021-07-30
Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain NCT02445599	Phase 4	Completed	University of Debrecen	3	2014-04 → 2016-04
Influence of Age, Sepsis and SLCO1A2 Polymorphisms on Rocuronium Pharmacokinetics NCT02399397	Phase 4	Completed	Universidade Estadual Paulista Júlio de Mesquita Filho	36	2014-02 → 2015-12

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

API Supply Chain5 active DMFs9 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

VERANOVA LPFENTANYL CITRATE (BULK)

DMF 50381983

SPECGX LLCFENTANYL CITRATE (NEW PROCESS)

DMF 101281993

CAMBREX CHARLES CITY INCFENTANYL CITRATE USP

DMF 170552003

CURIA WISCONSIN INCFENTANYL CITRATE

DMF 181782005

CHATTEM CHEMICALS INCFENTANYL CITRATE USP

DMF 230132009

DIOSYNTH BVInactiveFENTANYL CITRATE

DMF 47511983

PENCO OF LYNDHURST INCInactiveFENTANYL CITRATE, BULK FORM

DMF 47521983

MALLINCKRODT CHEMICAL INCInactiveFENTANYL CITRATE USP

DMF 70511987

ABBOTT PHARMACEUTICALS INCInactiveFENTANYL CITRATE

DMF 82791989

JOHNSON MATTHEY INCInactiveFENTANYL CITRATE

DMF 85131990

BOEHRINGER INGELHEIM CHEMICALS INCInactiveFENTANYL CITRATE

DMF 178262004

NV ORGANONInactiveFENTANYL CITRATE

DMF 190812006

CAMBREX CHARLES CITY INCInactiveFENTANYL CITRATE USP MICRONIZED

DMF 197242006

YICHANG HUMANWELL PHARMACEUTICAL CO LTDInactiveFENTANYL CITRATE, NON-STERILE BULK DRUG SUBSTANCE

DMF 207742007

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2025	SUPPL -2	View Letter (PDF)
Dec 19, 2023	SUPPL -1	View Letter (PDF)
Feb 9, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 8, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 8, 2023