FACTREL
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
FACTREL by Hikma is mechanism of action follicular cysts are enlarged non-ovulatory follicles resulting from a malfunction of the neuroendocrine mechanism controlling follicular maturation and ovulation. First approved in 1982.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FACTREL (gonadorelin hydrochloride) is a small-molecule GnRH agonist administered by injection that induces release of endogenous luteinizing hormone (LH) to treat follicular cysts in cattle. It works by stimulating the neuroendocrine mechanism controlling follicular maturation and ovulation in bovine reproduction.
LOE Approaching
Approaching loss of exclusivity with moderate competitive pressure (30%) signals need for lifecycle management and potential transition planning within the brand team.
Mechanism of Action
MECHANISM OF ACTION Follicular cysts are enlarged non-ovulatory follicles resulting from a malfunction of the neuroendocrine mechanism controlling follicular maturation and ovulation. Exogenous administration of agents possessing luteinizing hormone (LH) activity, such as pituitary extracts or…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on FACTREL offers experience in niche veterinary pharmaceuticals and animal health market dynamics, but limited job openings suggest a small, stable team. Professionals should expect focus on portfolio optimization and cost leadership as the product approaches LOE.
Brand Manager
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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.