BLASUBCUTANEOUSINJECTABLE
Approved
Mar 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
FOLLISTIM AQ (follitropin) by Merck & Co. is women: follicle-stimulating hormone (fsh), the active component in follistim aq cartridge, is required for normal follicular growth, maturation, and gonadal steroid production. First approved in 2004.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOLLISTIM AQ is a recombinant follicle-stimulating hormone (FSH) gonadotropin administered subcutaneously for ovulation induction in women with anovulation and for spermatogenesis in men with hypogonadotropic hypogonadism. It stimulates follicular growth and maturation in women and requires co-administration of hCG to complete the final phase of follicle maturation and ovulation. In men, it works synergistically with hCG to restore spermatogenesis.
LOE Approaching
As a legacy product approaching loss of exclusivity with moderate competitive pressure (30/100), the brand team is likely focused on market defense and transition planning rather than aggressive expansion.
Mechanism of Action
Women: Follicle-stimulating hormone (FSH), the active component in FOLLISTIM AQ Cartridge, is required for normal follicular growth, maturation, and gonadal steroid production. In women, the level of FSH is critical for the onset and duration of follicular development, and consequently for the…
Pharmacologic Class:
Gonadotropin
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Started Feb 2026
266 enrolled
Infertility
Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
Started Dec 2025
80 enrolled
InfertilityInsemination
A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants
Started Jul 2025
55 enrolled
Hypogonadism
An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.
Started Jul 2024
106 enrolled
Infertility
An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation
Started Jun 2024
310 enrolled
Fertility
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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.