Provider Briefing: Gonal-F Supply Constraints in 2026

Gonal-F (follitropin alfa, EMD Serono) continues to face intermittent supply constraints that directly affect fertility treatment planning. For reproductive endocrinologists, OB/GYNs, and other prescribers managing patients on gonadotropin therapy, understanding the current landscape is essential for maintaining treatment continuity.

This briefing covers the supply situation, prescribing considerations, alternative protocols, cost implications, and tools to help your practice navigate Gonal-F availability challenges.

Supply Timeline and Current Status

Gonal-F has experienced periodic supply disruptions over the past several years. As a single-source biologic product in the US market, follitropin alfa availability is entirely dependent on EMD Serono's manufacturing capacity. Key supply factors:

• Manufacturing complexity: Gonal-F is produced via recombinant DNA technology using Chinese hamster ovary (CHO) cells. The biologic manufacturing process is lengthy and subject to batch-level quality control — any failure can delay supply for weeks or months.
• No US biosimilar: Despite the availability of follitropin alfa biosimilars in the European market (Ovaleap/Teva, Bemfola/Gedeon Richter), no biosimilar application has been approved by the FDA. This leaves Gonal-F as the only follitropin alfa product available in the United States.
• Demand pressures: IVF cycle volume continues to increase nationally, driven by expanded state insurance mandates, delayed childbearing trends, and growing fertility preservation utilization. SART data shows year-over-year growth in ART cycles.
• Distribution fragmentation: Gonal-F is distributed through specialty pharmacy channels with cold-chain requirements. Availability can vary significantly between distributors, specialty pharmacies, and clinic-based dispensaries.

The net result: while Gonal-F is not always formally listed on the FDA Drug Shortage Database, real-world availability at the pharmacy level has been inconsistent, particularly for the 900 IU Redi-ject pen.

Prescribing Implications

Supply constraints create several practical challenges for prescribers:

Protocol Flexibility

Consider building flexibility into stimulation protocols when possible. Patients who can use either Gonal-F or Follistim AQ (follitropin beta) give you a fallback option if one product is unavailable. While these products are not FDA-rated as interchangeable, clinical data supports comparable efficacy and safety profiles, and most REIs consider them clinically substitutable.

Dose Optimization

Given supply constraints, dose optimization takes on additional importance. Careful monitoring and individualized dosing — particularly avoiding unnecessarily high starting doses — helps conserve supply and reduce medication waste. This is especially relevant for multi-dose vials, where leftover medication from overfills can be utilized within the labeled stability window.

Advance Medication Sourcing

Encourage patients to begin sourcing medications as soon as the protocol is established — ideally 1-2 weeks before cycle start. Provide prescriptions promptly and consider designating preferred specialty pharmacies that maintain reliable Gonal-F inventory.

The Availability Picture: Where to Find Gonal-F

Current availability patterns suggest the following hierarchy for sourcing:

1. Specialty fertility pharmacies — Freedom Fertility, Encompass Fertility, Village Fertility Pharmacy, and Alto Pharmacy typically maintain dedicated gonadotropin inventory with manufacturer allocation agreements.
2. Clinic dispensaries — Practices with in-house dispensaries have the most direct control over supply. If your practice doesn't currently operate a dispensary, this may warrant consideration.
3. Specialty divisions of retail chains — CVS Specialty, Walgreens Specialty, and similar entities may carry Gonal-F but with less consistent supply than dedicated fertility pharmacies.
4. Real-time availability tools — Medfinder for Providers allows you and your staff to check Gonal-F availability across pharmacies in real time, reducing phone-tag and patient delays.

Cost and Access Considerations

Gonal-F costs remain significant and can create barriers to treatment adherence:

• Cash pricing: $900-$1,500 per 900 IU Redi-ject pen; $1,800-$6,000+ per IVF cycle for Gonal-F alone
• Insurance variability: Coverage depends on plan design and state mandates. Prior authorization is standard. Step therapy requirements may mandate oral agents before approving gonadotropins.
• Manufacturer programs: EMD Serono's Compassionate Care Program provides free Gonal-F to eligible uninsured/underinsured patients. Fertility Lifelines (1-866-538-7879) can assist with enrollment and supply questions.
• Financial counseling: Proactive financial counseling at the practice level — including insurance verification, manufacturer program enrollment, and specialty pharmacy selection — can significantly reduce patient out-of-pocket burden.

For a patient-facing resource on cost savings, consider sharing: How to Save Money on Gonal-F.

Tools and Resources for Your Practice

• Medfinder for Providers — real-time medication availability search to help your staff and patients locate Gonal-F quickly
• EMD Serono Fertility Lifelines: 1-866-538-7879 — manufacturer supply support and Compassionate Care Program enrollment
• FDA Drug Shortage Database: accessdata.fda.gov/scripts/drugshortages — official shortage listings
• ASRM Practice Guidelines: The American Society for Reproductive Medicine publishes guidance on gonadotropin use and shortage management

Looking Ahead

Several developments could improve the Gonal-F availability landscape in the coming years:

• Biosimilar pipeline: While no follitropin alfa biosimilar is currently approved in the US, the regulatory pathway exists and European biosimilars have established safety records. FDA approval of a US biosimilar would significantly reduce single-source risk.
• Manufacturing capacity: EMD Serono has invested in production infrastructure, though biologic capacity expansion is measured in years, not months.
• Practice-level dispensing: More practices are establishing in-house dispensaries, improving supply chain resilience.

In the interim, proactive medication sourcing, protocol flexibility, and strong pharmacy partnerships remain the most effective strategies for ensuring patients can access Gonal-F when they need it.

Final Thoughts

The Gonal-F supply situation requires ongoing vigilance from fertility practices. By building protocol flexibility, establishing relationships with reliable specialty pharmacies, leveraging real-time tools like Medfinder for Providers, and connecting patients with financial assistance programs, you can minimize treatment disruptions and keep your patients on track.

For a patient-facing perspective on the shortage, share our guide: Gonal-F Shortage Update: What Patients Need to Know in 2026. For practical guidance on helping patients source their medication, see our provider's guide to helping patients find Gonal-F.