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, Eugia Pharma, 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.Nine suppliers are listed for this compound.
Summary for caffeine citrate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 9 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 34 |
| Clinical Trials: | 30 |
| Patent Applications: | 586 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for caffeine citrate |
| What excipients (inactive ingredients) are in caffeine citrate? | caffeine citrate excipients list |
| DailyMed Link: | caffeine citrate at DailyMed |
Recent Clinical Trials for caffeine citrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Amgen | Early Phase 1 |
| National Institute on Aging (NIA) | Phase 2 |
| University of Michigan | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Micro Labs | CAFFEINE CITRATE | caffeine citrate | SOLUTION;ORAL | 213202-001 | Dec 16, 2019 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Fresenius Kabi Usa | CAFFEINE CITRATE | caffeine citrate | SOLUTION;INTRAVENOUS | 077997-001 | Jul 20, 2007 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Exela Pharma Science | CAFFEINE CITRATE | caffeine citrate | SOLUTION;INTRAVENOUS | 077233-001 | Sep 21, 2006 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Am Regent | CAFFEINE CITRATE | caffeine citrate | SOLUTION;ORAL | 090064-001 | Nov 20, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Micro Labs | CAFFEINE CITRATE | caffeine citrate | SOLUTION;INTRAVENOUS | 207400-001 | Dec 14, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sagent Pharms | CAFFEINE CITRATE | caffeine citrate | SOLUTION;ORAL | 091102-001 | Aug 29, 2012 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Fresenius Kabi Usa | CAFFEINE CITRATE | caffeine citrate | SOLUTION;ORAL | 078002-001 | Jan 31, 2008 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for caffeine citrate
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Gennisium Pharma | Gencebok | caffeine citrate | EMEA/H/C/005435 Treatment of primary apnoea of premature newborns. |
Authorised | no | no | no | 2020-08-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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