Viewing data from:

ONSOLIS

NDA

FENTANYL CITRATE | N022266 | ADALVO LTD

5 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)Today

2027

Today

9597288

Jul. 23, 2027

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

433 trials from ClinicalTrials.gov — 18 recruiting, 7 active, 280 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction NCT03105518	Phase 4	Active	Brigham and Women's Hospital	100	2011-03-01 → 2027-06-30
Total Intravenous Anesthesia in Patients Undergoing Craniotomy NCT07105618	N/A	Active	Zagazig University	120	2025-08-10 → 2027-06
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 → 2027-07-31
Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour NCT04011150	Phase 3	Active	KK Women's and Children's Hospital	197	2020-08-11 → 2027-08-31
Comparison of Regimens MPIB, CIPCEA, PCEA NCT02278601	Phase 3	Active	KK Women's and Children's Hospital	839	2015-01-28 → 2027-12-31
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 → 2027-12-31
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
Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants NCT07112430	Phase 1/2	Not Yet Recruiting	Marsha Campbell-Yeo	58	2026-09-09 → 2028-06-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

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

14 letters from Drugs@FDA

Date	Submission	Document
Aug 18, 2022	SUPPL -27	View Letter (PDF)
Dec 20, 2021	SUPPL -26	View Letter (PDF)
Mar 5, 2021	SUPPL -25	View Letter (PDF)
Dec 28, 2020	SUPPL -24	View Letter (PDF)
Oct 9, 2019	SUPPL -23	View Letter (PDF)
Sep 11, 2017	SUPPL -19	View Letter (PDF)
Dec 20, 2016	SUPPL -18	View Letter (PDF)
Dec 20, 2016	SUPPL -17	View Letter (PDF)
Dec 30, 2014	SUPPL -14	View Letter (PDF)
Nov 8, 2013	SUPPL -12	View Letter (PDF)
Jun 7, 2012	SUPPL -9	View Letter (PDF)
Jan 3, 2012	SUPPL -8	View Letter (PDF)
Jul 8, 2010	SUPPL -1	View Letter (PDF)
Jul 17, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.