NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Sep 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
CAFCIT (caffeine citrate) by Hikma is mechanism of action caffeine is structurally related to other methylxanthines, theophylline, and theobromine. First approved in 1999.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAFCIT (caffeine citrate) is an intravenous solution containing caffeine, a methylxanthine CNS stimulant approved for apnea of prematurity in neonates. It works primarily through adenosine receptor antagonism to stimulate the respiratory center, increase minute ventilation, and reduce diaphragmatic fatigue in premature infants.
LOE Approaching
Approaching loss of exclusivity signals transition from maintenance to generic defense strategies; brand team focus likely shifting to cost management and niche positioning.
Mechanism of Action
Mechanism of Action Caffeine is structurally related to other methylxanthines, theophylline, and theobromine. It is a bronchial smooth muscle relaxant, a CNS stimulant, a cardiac muscle stimulant, and a diuretic. Although the mechanism of action of caffeine in apnea of prematurity is not known,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on CAFCIT offers limited career growth given the zero linked job openings and approaching loss of exclusivity; roles are primarily defensive and cost-focused rather than growth-oriented. This product is best suited for professionals skilled in mature product management, generic defense strategies, and niche market positioning.
Worked on CAFCIT at Hikma? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.