Last reviewed · How we verify
GONAL f® prefilled pen
GONAL f® prefilled pen, marketed by Merck KGaA, Darmstadt, Germany, holds a significant position in the reproductive health market. The key composition patent is set to expire in 2028, providing a strong competitive advantage until then. The primary risk is the potential increase in competition post-patent expiry.
At a glance
| Generic name | GONAL f® prefilled pen |
|---|---|
| Also known as | Follitropin alfa, Recombinant human follicle stimulating hormone (r-hFSH), GONAL-f® Prefilled Pen, r-hFSH |
| Sponsor | Merck KGaA, Darmstadt, Germany |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin (PHASE1)
- Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment (PHASE4)
- Recombinant Follicle-stimulating Hormone in Treatment for Infertility (PHASE3)
- An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029) (PHASE3)
- Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029) (PHASE3)
- Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization (PHASE3)
- Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF) (PHASE4)
- Low-dose Gonal-f® in Ovulation Induction (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- GONAL f® prefilled pen CI brief — competitive landscape report
- GONAL f® prefilled pen updates RSS · CI watch RSS
- Merck KGaA, Darmstadt, Germany portfolio CI