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: | 31 |
Patent Applications: | 534 |
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 |
---|---|
Al-Azhar University | Early Phase 1 |
Amgen | Early Phase 1 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sagent Pharms | CAFFEINE CITRATE | caffeine citrate | SOLUTION;ORAL | 091102-001 | Aug 29, 2012 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | CAFCIT | caffeine citrate | SOLUTION;ORAL | 020793-002 | Apr 12, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Exela Pharma | CAFFEINE CITRATE | caffeine citrate | SOLUTION;ORAL | 077304-001 | Sep 21, 2006 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 |
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