NDASUBCUTANEOUSINJECTABLE
Approved
Sep 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
2/8 — Basic
Drug data last refreshed 16h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FERTINEX (urofollitropin) is a purified urinary-derived follicle-stimulating hormone (FSH) administered via subcutaneous injection. It is indicated for ovulation induction in women with polycystic ovary syndrome (PCOS) and for stimulation of spermatogenesis in men with primary hypogonadism. The drug works by stimulating the development and maturation of ovarian follicles or testicular function.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), suggesting defensive positioning and possible team consolidation in coming years.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females
Started Oct 2013
215 enrolled
Anovulation
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program
Started Oct 2013
263 enrolled
Infertility
Career Relevance
Working on FERTINEX offers exposure to specialty pharma and fertility markets with established commercial infrastructure, but limited growth potential due to LOE proximity. Career progression will depend on defensive strategy execution and ability to transition to next-generation fertility products.
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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.