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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.
Summary for caffeine citrate
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 |
Recent Clinical Trials for caffeine citrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Medical University of Warsaw | Phase 1 |
University of Florence | N/A |
Ain Shams University | Phase 3 |
Pharmacology for caffeine citrate
Drug Class | Central Nervous System Stimulant Methylxanthine |
Physiological Effect | Central Nervous System Stimulation |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 |
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