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CAFCIT

NDA

CAFFEINE CITRATE | N020793 | HIKMA PHARMACEUTICALS USA INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Caffeine for Hypoxic Ischemic Encephalopathy NCT06855108	Phase 3	Recruiting	NICHD Global Network for Women's and Children's Health	830	2026-04-08 → 2030-07
Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia NCT06518603	Phase 4	Recruiting	University of Alabama at Birmingham	340	2026-06-17 → 2027-06-30

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

API Supply Chain4 active DMFs3 inactive

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

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHCAFFEINE (HYDROUS, ANHYDROUS FORMS)

DMF 50321983

SHANDONG XINHUA PHARMACEUTICAL CO LTDCAFFEINE ANHYDROUS

DMF 130921998

CSPC INNOVATION PHARM CO LTDCaffeine

DMF 210022007

AARTI PHARMALABS LTDCAFFEINE (ANHYDROUS)

DMF 412822025

CULTOR FOOD SCIENCE INCInactiveCAFFEINE

DMF 61821986

AMERICAN BIO SYNTHETICS CORPInactiveCAFFEINE

DMF 90271991

TIANJIN ZHONGAN PHARMACEUTICAL CO LTDInactiveCAFFEINE (ANHYDROUS)

DMF 174862004

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2020	SUPPL -19	View Letter (PDF)
Jun 16, 2010	SUPPL -9	View Letter (PDF)
Feb 8, 2002	SUPPL -4	View Letter (PDF)
Jan 18, 2002	SUPPL -3	View Letter (PDF)
Apr 12, 2000	SUPPL -1	View Letter (PDF)
Sep 21, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Sep 21, 1999

No patent or exclusivity listings for this strength.

#002 — EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Apr 12, 2000