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SUBLIMAZE PRESERVATIVE FREE

NDA

FENTANYL CITRATE | N016619 | 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 - "ANDA Suitability Petition for Fentanyl Citrate Injection USP"... FDA-2010-P-0413 Olsson Frank Weeda Terman Bode Matz PC filed a citizen petition requesting that the FDA determine fentanyl citrate injection USP is suitable for abbreviated new drug application approval, enabling generic manufacturers to pursue ANDA pathways for this injectable fentanyl product.	Suitability	2010-08-10	Open	—

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

Clinical Trials

5 trials from ClinicalTrials.gov — 4 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl NCT06995885	—	By Invitation	National Institute on Drug Abuse (NIDA)	30	2026-07-07 → 2027-05-31
Intraperitoneal Ketamine Versus Fentanyl as Adjuvants to Bupivacaine in Laparoscopic Cholecystectomy NCT07670052	Phase 4	Not Yet Recruiting	Assiut University	84	2026-08-01 → 2027-09-01
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy NCT06441604	Phase 2	Recruiting	Brigham and Women's Hospital	30	2025-10-27 → 2027-01-31
A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle NCT05856136	Phase 4	Recruiting	Mayo Clinic	69	2023-06-19 → 2027-01-01
Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures NCT07664618	N/A	Completed	Helwan University	100	2024-04-01 → 2025-05-31

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

API Supply Chain5 active DMFs7 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

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

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2025	SUPPL -56	View Letter (PDF)
Dec 19, 2023	SUPPL -54	View Letter (PDF)
Dec 19, 2023	SUPPL -27	View Letter (PDF)
Feb 9, 2023	SUPPL -45	View Letter (PDF)
Apr 13, 2022	SUPPL -52	View Letter (PDF)
Oct 9, 2019	SUPPL -43	View Letter (PDF)
Feb 13, 2019	SUPPL -39	View Letter (PDF)
Dec 19, 2016	SUPPL -38	View Letter (PDF)
Jul 8, 2013	SUPPL -34	View Letter (PDF)
Oct 22, 2003	SUPPL -32	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.05MG BASE/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.