The End of the GLP-1 Shortage: Latest Updates on Tirzepatide & Semaglutide

Introduction

In February 2025, the U.S. Food and Drug Administration (FDA) officially announced that the supply shortage of Semaglutide (a GLP-1 receptor agonist marketed as Ozempic and Wegovy) was resolved.
Similarly, by the end of 2024, the FDA made a comparable statement regarding Tirzepatide (Mounjaro/Zepbound), indicating that the compounding pharmacies that had been producing “copycat” versions during the shortage period would face significant changes.
This article explores the impact of these FDA announcements on compounding pharmacies, patients, physicians, and major pharmaceutical companies such as Eli Lilly and Novo Nordisk.

Impact on the Compounding Pharmacy Market

Previously, in the United States, the inclusion of Semaglutide and Tirzepatide on the FDA’s “drug shortage list” allowed compounding pharmacies to manufacture near-generic versions of these medications. However, once the FDA declared the shortage to be over, “the original branded drugs are now sufficiently available, so compounding is unnecessary and no longer permitted”.

◆ FDA’s Transition Period

• The FDA granted a 60–90 day grace period following the announcement, after which compounded Semaglutide and Tirzepatide can no longer be legally produced or sold
• Organizations representing compounding pharmacies have voiced opposition, citing potential harm to patients if future shortages reoccur
• Some pharmacies and digital health platforms (e.g., Hims & Hers) are exploring legal avenues to contest the ruling

As a result, these “lower-cost alternatives” are essentially being shut out of the market. On one hand, the decision could enhance overall patient safety and quality control; on the other, it poses a significant blow to the compounding industry.

Impact on Patients: Changes in Price & Access

Compounded Semaglutide or Tirzepatide products often cost less than $200 per month, sometimes even as low as $100. With stricter regulations limiting these compounded versions, patients may now face monthly costs exceeding $1,000 for the branded medications.

◆ Insurance Coverage Concerns

• Patients with diabetes (using Ozempic or Mounjaro) are more likely to receive insurance coverage
• For obesity treatments (Wegovy or Zepbound), many insurance plans still do not offer coverage, leading to significant out-of-pocket costs

This scenario could lead to widening access disparities as some patients may no longer afford or continue treatment. Yet from a safety standpoint, avoiding unregulated or counterfeit products is a positive outcome.

Impact on Physicians: Prescription Choices & Treatment Continuity

During times of shortage, many physicians prescribed compounded GLP-1 therapies out of necessity. With the FDA’s latest move, however, “practitioners will largely be restricted to prescribing official Ozempic/Wegovy or Mounjaro/Zepbound”.

◆ Physicians’ Concerns & Strategies

• The high cost of brand-name drugs may pose a barrier to long-term treatment adherence
• Negotiating prior authorization with insurers and informing patients of cost-assistance programs will likely increase
• Potentially fewer safety risks and dosing errors compared to compounded versions, thus improved risk management

Physicians will continue referencing GLP-1 prescribing guidelines and evaluating cost-effectiveness for individual patients, aiming to provide a sustainable treatment plan.

Impact on Pharmaceutical Companies (Eli Lilly & Novo Nordisk)

With compounding pharmacies effectively regulated out of this space, the monopoly held by brand-name drugs is poised to intensify. Both Eli Lilly (Tirzepatide) and Novo Nordisk (Semaglutide) have “welcomed the availability of safe and reliable FDA-approved medications” and are supportive of stricter FDA oversight.

◆ Market Dominance & Pricing Strategies

• Eliminating lower-priced compounded products allows continued premium pricing for brand medications
• With a vast U.S. market — especially given the high obesity and diabetes prevalence — overall demand will likely keep growing
• High prices could lead to public criticism and increased payer burdens, potentially prompting government interventions and reimbursement reforms

Ongoing legal disputes with compounding pharmacies may subside, but access issues and cost concerns remain top-of-mind for policymakers and patient advocates alike.

Future Outlook: Supply Stability, Pricing, and Regulations

The FDA’s decision to deem these drugs “no longer in shortage” signifies that at least temporarily, supply meets current demand. However, with a growing population of obese and diabetic patients, there is always a chance new shortages may arise.
In such an event, whether compounding will be permitted again remains to be seen. Based on the FDA’s current stance, it appears the agency is pursuing a “tighter regulatory approach”.

Meanwhile, policies aimed at lowering medication costs for uninsured or underinsured patients — including potential Medicare/Medicaid reforms or expanded coupon programs — could gain traction. These developments warrant close monitoring.

References

1. FDA Drug Shortage Database: Semaglutide and Tirzepatide (2024–2025)
2. Fierce Pharma: “Hims & Hers, Compounding GLP-1 Drugs, and the FDA’s Final Stance” (2025)
3. Press Releases from Novo Nordisk & Eli Lilly (2024–2025)
4. American Society of Bariatric Physicians (2024) – Statement on the Appropriate Use of GLP-1 Therapies