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FOLLITROPIN BETA
FOLLITROPIN BETA is a drug. It is currently FDA-approved (first approved 1996).
Follitropin beta is a marketed drug used primarily in fertility treatments, positioning it in a segment with established demand. Its key strength lies in its composition, which is protected by a patent expiring in 2028, providing a significant period of market exclusivity. The primary risk is the eventual patent expiry, which could lead to increased competition from generic versions.
At a glance
| Generic name | FOLLITROPIN BETA |
|---|---|
| Modality | Recombinant protein |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
Common side effects
Key clinical trials
- An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin (PHASE1)
- 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) (PHASE3)
- Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin
- Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. (PHASE3)
- A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants (PHASE1)
- Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers (PHASE1)
- A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China (PHASE3)
- rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- FOLLITROPIN BETA CI brief — competitive landscape report
- FOLLITROPIN BETA updates RSS · CI watch RSS
Frequently asked questions about FOLLITROPIN BETA
What is FOLLITROPIN BETA?
When was FOLLITROPIN BETA approved?
What development phase is FOLLITROPIN BETA in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing