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Last Updated: November 2, 2024

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.

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Summary for CAFFEINE CITRATE
Drug patent expirations by year for CAFFEINE CITRATE
Drug Prices for CAFFEINE CITRATE

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Recent Clinical Trials for CAFFEINE CITRATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Al-Azhar UniversityEarly Phase 1
AmgenEarly Phase 1
National Institute on Aging (NIA)Phase 2

See all CAFFEINE CITRATE clinical trials

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
Am Regent CAFFEINE CITRATE caffeine citrate SOLUTION;INTRAVENOUS 077906-001 May 15, 2007 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm CAFFEINE CITRATE caffeine citrate SOLUTION;INTRAVENOUS 090077-001 Sep 30, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa CAFFEINE CITRATE caffeine citrate SOLUTION;INTRAVENOUS 077997-001 Jul 20, 2007 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sagent Pharms CAFFEINE CITRATE caffeine citrate SOLUTION;ORAL 091102-001 Aug 29, 2012 AA RX No No ⤷  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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