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Caffeine citrate - Generic Drug Details

What are the generic drug sources for caffeine citrate and what is the scope of patent protection?

Caffeine citrate is the generic ingredient in two branded drugs marketed by Hikma, Am Regent, Aurobindo Pharma Ltd, Exela Pharma Science, Fresenius Kabi Usa, Micro Labs, Sagent Pharms, Sun Pharm, and Exela Pharma, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for caffeine citrate. Eight suppliers are listed for this compound.

Sponsor	Phase
Medical University of Warsaw	Phase 1
University of Florence	N/A
Ain Shams University	Phase 3

Sponsor

Phase

Medical University of Warsaw

Phase 1

University of Florence

N/A

Ain Shams University

Phase 3

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	077997-001	Jul 20, 2007	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Exela Pharma	CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	077304-001	Sep 21, 2006	AA	RX	No	No	Start Trial	Start Trial				Start Trial
Hikma	CAFCIT	caffeine citrate	SOLUTION;INTRAVENOUS	020793-001	Sep 21, 1999	AP	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Sun Pharm	CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	090077-001	Sep 30, 2009		DISCN	No	No	Start Trial	Start Trial				Start Trial
Sun Pharm	CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	090357-001	Sep 30, 2009	AA	RX	No	No	Start Trial	Start Trial				Start Trial
Sagent Pharms	CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	091102-001	Aug 29, 2012	AA	RX	No	No	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	14
Drug Master File Entries:	11
Suppliers / Packagers:	8
Bulk Api Vendors:	27
Clinical Trials:	22
Patent Applications:	231
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for caffeine citrate
DailyMed Link:	caffeine citrate at DailyMed

Drug Class	Central Nervous System Stimulant Methylxanthine
Physiological Effect	Central Nervous System Stimulation