Novarel Shortage: What Providers and Prescribers Need to Know in 2026

Updated:

February 18, 2026

Author:

Peter Daggett

Summarize this blog with AI:

A provider briefing on the Novarel (hCG) shortage in 2026. Timeline, prescribing implications, availability data, cost considerations, and clinical tools.

Provider Briefing: The Novarel (hCG) Shortage in 2026

The shortage of human chorionic gonadotropin (hCG) products — including Novarel, Pregnyl, and generic formulations — has been one of the most impactful specialty medication shortages in reproductive medicine. For providers in reproductive endocrinology, urology, and endocrinology, this shortage has required ongoing adaptation in prescribing practices, patient counseling, and pharmacy coordination.

This briefing provides an updated overview of the shortage landscape in 2026, with actionable information for clinical practice.

Shortage Timeline

Understanding the history of this shortage is important for contextualizing the current situation:

  • March 2020: The FDA reclassified hCG as a biologic product under the Biologics Price Competition and Innovation Act (BPCIA). This transition moved hCG from the Federal Food, Drug, and Cosmetic Act framework to the Public Health Service Act framework.
  • 2020–2021: 503A compounding pharmacies lost the ability to compound hCG. Some 503B outsourcing facilities received temporary enforcement discretion from the FDA, but most compounding sources dried up. This removed a substantial portion of the hCG supply chain — particularly for male hypogonadism patients who had been using affordable compounded hCG.
  • 2021–2023: Intermittent shortages of Novarel, Pregnyl, and generic hCG were reported to the ASHP Drug Shortage Resource Center. Availability fluctuated by region and distributor.
  • 2024–2025: Supply stabilized somewhat as manufacturers adjusted production, but availability remained inconsistent. Specialty pharmacies became the most reliable source for hCG products.
  • 2026 (current): hCG remains on the ASHP shortage list. Supply is improved but not fully resolved. Patients and providers continue to report difficulty sourcing hCG through standard retail pharmacy channels.

Prescribing Implications

The shortage has several practical implications for prescribers:

Prescription Flexibility

Writing prescriptions for generic chorionic gonadotropin rather than specifying Novarel by brand name gives pharmacies maximum flexibility to fill from available stock. If a specific brand is required for clinical reasons, documenting the rationale supports prior authorization processes.

Dosage Form Considerations

Novarel and Pregnyl are available in 5,000 and 10,000 USP Unit vials for intramuscular injection. Ovidrel (choriogonadotropin alfa) is available as a 250 mcg pre-filled syringe for subcutaneous injection. Key clinical considerations when substituting:

  • Ovidrel 250 mcg is approximately equivalent to 6,500 IU of urinary-derived hCG
  • Ovidrel is administered subcutaneously — ensure patients receive appropriate injection instructions
  • Ovidrel is FDA-approved only for ovulation induction and ART, not for male hypogonadism or cryptorchidism

Male Hypogonadism Considerations

For male patients using hCG to maintain spermatogenesis while on testosterone therapy or to treat hypogonadotropic hypogonadism, the shortage has been particularly impactful. These patients require ongoing, repeated doses (typically 500–2,000 IU two to three times weekly). Prescribers should:

  • Establish relationships with specialty pharmacies that maintain hCG inventory
  • Consider prescribing in quantities that allow multi-week supply
  • Discuss alternative approaches (e.g., clomiphene citrate, enclomiphene) when appropriate, recognizing these are off-label for this indication

Current Availability Picture

As of early 2026, availability varies by product and distribution channel:

  • Novarel (Ferring): Intermittently available. Specialty fertility pharmacies are the most reliable source.
  • Pregnyl (Organon): Similar availability pattern to Novarel. May be more consistently stocked at hospital-affiliated pharmacies.
  • Generic hCG (Fresenius Kabi): Availability has improved. Often the most accessible option through standard distribution channels.
  • Ovidrel (EMD Serono): Generally more available than urinary-derived hCG products due to recombinant manufacturing. Higher cost may be a limiting factor for patients.

Providers can direct patients and staff to Medfinder for Providers to check real-time pharmacy-level availability data for hCG products.

Cost and Access Considerations

The loss of compounded hCG has had a significant cost impact on patients:

  • Pre-2020 compounded hCG: $30–$80 per vial
  • Current brand-name Novarel: $200–$500 per vial
  • Generic hCG with discount cards: $150–$300 per vial
  • Ovidrel: $250–$500+ per pre-filled syringe

Insurance coverage for hCG depends on the indication and plan. Key considerations:

  • Fertility indications: Covered in states with fertility mandates; prior authorization almost always required. UnitedHealthcare, Cigna, and Blue Cross policies have specific PA criteria for hCG.
  • Non-fertility indications: May be covered under medical benefit (J-code J0725) with appropriate documentation. Step therapy may be required.
  • Cash-pay patients: Ferring offers the HeartTomorrow and OneHeart programs for eligible patients. Discount cards (GoodRx, SingleCare) can reduce out-of-pocket costs significantly.

Tools and Resources for Your Practice

Several resources can help streamline hCG access for your patients:

  • Medfinder for Providers: Real-time pharmacy inventory search to help patients locate hCG products in stock.
  • Ferring Fertility (ferringfertility.com): Product information, patient support programs, and prescribing resources.
  • ASHP Drug Shortage Database: Official shortage status and manufacturer updates for chorionic gonadotropin.
  • Specialty pharmacy networks: Establish relationships with 2–3 specialty pharmacies that consistently stock hCG products. This is the single most effective strategy for ensuring patient access.

For a practical workflow guide, see our article on how to help your patients find Novarel in stock.

Looking Ahead

Several developments may impact hCG availability in the coming months and years:

  • Legislative activity: Ongoing Congressional discussions about compounding access for biologic products could potentially restore some compounding pharmacy supply.
  • Manufacturer capacity: Ferring and other manufacturers have indicated efforts to increase production capacity, though timelines remain uncertain.
  • Biosimilar development: The biologic pathway theoretically opens the door for biosimilar hCG products, though none are currently in late-stage development for the U.S. market.
  • Alternative protocols: Some fertility clinics have explored kisspeptin and GnRH agonist trigger protocols as alternatives to hCG triggers in specific clinical scenarios.

Final Thoughts

The hCG shortage has persisted for over five years and shows no signs of complete resolution in 2026. Proactive management — including flexible prescribing, specialty pharmacy relationships, and patient education — remains the most effective approach.

Providers can help patients navigate both finding Novarel and saving money on hCG products. For real-time availability data, visit Medfinder for Providers.

Should I prescribe Novarel by brand name or generic?

In most cases, prescribing generic chorionic gonadotropin for injection gives pharmacies the most flexibility to fill from available stock. Specify Novarel by brand only if there is a clinical reason — such as patient tolerance or insurer requirement — and document accordingly.

Can I substitute Ovidrel for Novarel in male hypogonadism patients?

Ovidrel (choriogonadotropin alfa) is FDA-approved only for ovulation induction and assisted reproductive technology, not for male hypogonadism or cryptorchidism. Using Ovidrel for these indications would be off-label. Consider generic hCG or Pregnyl as alternatives for male patients.

What is the J-code for billing Novarel under medical benefit?

The J-code for chorionic gonadotropin injection is J0725 (per 1,000 USP units). This code applies to Novarel, Pregnyl, and generic hCG for injection when administered in a clinical setting and billed under the medical benefit.

How can I help patients who can't afford Novarel without insurance?

Direct patients to Ferring's HeartTomorrow and OneHeart patient support programs, which offer discounted pricing for eligible cash-paying patients. Discount cards from GoodRx and SingleCare can bring the price of generic hCG down to approximately $150–$300 per vial. For patients with financial hardship, NeedyMeds and RxAssist maintain databases of patient assistance programs.

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