CAFFEINE CITRATE Drug Patent Profile
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When do Caffeine Citrate patents expire, and what generic alternatives are available?
Caffeine Citrate is a drug marketed by Am Regent, Eugia Pharma, Exela Pharma Science, Fresenius Kabi Usa, Micro Labs, Sagent Pharms, Sun Pharm, and Exela Pharma. and is included in thirteen NDAs.
The generic ingredient in CAFFEINE CITRATE is caffeine citrate. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the caffeine citrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Caffeine Citrate
A generic version of CAFFEINE CITRATE was approved as caffeine citrate by EXELA PHARMA SCIENCE on September 21st, 2006.
Summary for CAFFEINE CITRATE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 34 |
| Clinical Trials: | 30 |
| Patent Applications: | 321 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | CAFFEINE CITRATE | caffeine citrate | SOLUTION;INTRAVENOUS | 077906-001 | May 15, 2007 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | CAFFEINE CITRATE | caffeine citrate | SOLUTION;INTRAVENOUS | 090077-001 | Sep 30, 2009 | DISCN | 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 | |||
| 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 | |||
| 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 | ||||
| Eugia Pharma | CAFFEINE CITRATE | caffeine citrate | SOLUTION;INTRAVENOUS | 205013-001 | Sep 22, 2015 | AP | 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 |
