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Last Updated: September 24, 2020

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CAFFEINE CITRATE - Generic Drug Details

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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.

Drug Prices for CAFFEINE CITRATE

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Recent Clinical Trials for CAFFEINE CITRATE

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SponsorPhase
Medical University of WarsawPhase 1
University of FlorenceN/A
Ain Shams UniversityPhase 3

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Pharmacology for CAFFEINE CITRATE
Medical Subject Heading (MeSH) Categories for CAFFEINE CITRATE

US Patents and Regulatory Information for CAFFEINE CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma CAFCIT caffeine citrate SOLUTION;ORAL 020793-002 Apr 12, 2000 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Exela Pharma Science CAFFEINE CITRATE caffeine citrate SOLUTION;INTRAVENOUS 077233-001 Sep 21, 2006 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa CAFFEINE CITRATE caffeine citrate SOLUTION;ORAL 078002-001 Jan 31, 2008 AA RX No No   Start Trial   Start Trial   Start Trial
Sagent Pharms CAFFEINE CITRATE caffeine citrate SOLUTION;INTRAVENOUS 090827-001 Aug 29, 2012 AP 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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Dow
Express Scripts
Mallinckrodt
Medtronic

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