Is Semaglutide Patented? (Is the Compounded Version Legal?)

What Does It Mean That Semaglutide Is Patented?

A patent grants a company exclusive rights to manufacture, market, and sell a drug for a specific time. For semaglutide:

• Novo Nordisk currently holds patents on the chemical structureof semaglutide, as well as various delivery systems used in products like Ozempic® and Wegovy®.
• These patents generally prevent other manufacturers from producing similar formulations without authorization until the patents expire.
  
  

This exclusivity protects the innovation but also limits access to generics in the short term.

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When Does the Patent on Semaglutide Expire?

Semaglutide’s base patent expires in 2026, but Novo Nordisk has filed numerous secondary patents on:

• Modified-release formulations
  
• Injection pens and dosing mechanisms
  
• Combination treatments and co-therapies
  
  

Certain secondary patents may extend protection through 2033 or beyond, which could delay the introduction of generic alternatives even after the primary patent expires.

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Can Semaglutide Be Compounded Legally?

Semaglutide may be compounded under specific circumstances permitted by federal law. Compounding is not the same as generic drug manufacturing. Instead, it involves preparing a customized formulation of a medication for an individual patient, typically when commercially available options are unavailable or unsuitable.

Under the U.S. Food, Drug, and Cosmetic Act (FDCA), a compounding pharmacy may prepare a semaglutide formulation only if all of the following conditions are met:

• The medication appears on the FDA’s official drug shortage list
• The pharmacy complies with applicable federal standards under Section 503A (for traditional compounding pharmacies) or Section 503B (for FDA-registered outsourcing facilities)
• A licensed healthcare provider issues a valid prescription for an individual patient

These requirements are intended to ensure that compounded medications are prepared safely, responsibly, and only when necessary. Compounded formulations are not FDA-approved, and their safety and effectiveness depend on the quality of the compounding process and oversight by a licensed healthcare provider.

Eden connects individuals with licensed healthcare providers who can evaluate their needs and, when appropriate, refer them to reputable, FDA-registered compounding pharmacies operating within the scope of federal law.

Learn more about personalized GLP-1 plans with Eden

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Is Compounded Semaglutide the Same as the Branded Version?

Not exactly. Although compounded semaglutide may use the same active pharmaceutical ingredient (API) as branded medications like Ozempic® or Wegovy®, there are key differences that affect consistency, safety, and oversight.

Compounded formulations may differ in:

• Formulation and concentration — Compounded versions are not standardized in the same way as FDA-approved products.
• Inactive ingredients — The excipients, preservatives, and stabilizers used may vary from those in branded medications.
• Manufacturing and quality control — Compounded medications are not subject to the same pre-market review or approval process as commercial drugs.

Because compounded semaglutide is not reviewed or approved by the FDA, patients should take extra steps to ensure safety and quality. This includes confirming that:

• The pharmacy is state-licensed and, if applicable, registered with the FDA as a 503B outsourcing facility.
• The active ingredient is sourced from FDA-registered manufacturers that follow appropriate quality standards.
• There is full transparency regarding sterility, storage conditions, and dosing information.

Patients should only use compounded medications under the supervision of a licensed healthcare provider who can monitor for safety, effectiveness, and appropriate use.

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Why Some Patients May Receive Compounded Semaglutide

Compounded semaglutide is not a substitute for FDA-approved medications and should only be used under specific conditions permitted by federal law. In certain situations, licensed healthcare providers may determine that a compounded version is appropriate for a patient when no suitable commercial product is available.

Here are some of the scenarios where compounding may be considered:

1. FDA-Declared Shortages

If semaglutide products such as Ozempic® or Wegovy® are listed on the FDA's official drug shortage list, compounding may be permitted to help ensure continued access to treatment when commercially manufactured options are temporarily unavailable.

2. Individualized Dosing Requirements

Some patients may require dosing regimens or formulations not available in standard commercial products. In these cases, a licensed healthcare provider may prescribe a compounded formulation that allows for a more gradual titration schedule or alternate delivery format, when medically appropriate and legally permissible.

Note: Any modifications such as combining semaglutide with additional ingredients (e.g., vitamin B12) have not been evaluated by the FDA and should only be prescribed with appropriate clinical justification by a licensed medical provider.

3. Sensitivity to Ingredients

Some individuals may have sensitivities or allergies to specific inactive ingredients—such as preservatives, dyes, or stabilizers—found in FDA-approved semaglutide products. In such cases, a licensed healthcare provider may determine that a compounded formulation is appropriate to help reduce the risk of adverse reactions.

Compounded semaglutide can sometimes be prepared without certain excipients that are present in branded medications. However, because compounded medications are not FDA-approved, patients should only use these formulations under the close supervision of a licensed healthcare provider.

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Under What Conditions Is Compounded Semaglutide Permissible?

Compounded semaglutide may be legally prepared and dispensed under specific federal and state regulations. Whether compounding is permissible depends on the type of pharmacy involved (503A vs. 503B), the prescribing provider’s clinical judgment, and the availability of FDA-approved alternatives.

In general, compounding may be considered lawful when:

• A licensed healthcare provider issues a valid prescription for an individual patient, based on a medical need that cannot be met by commercially available formulations
• The compounding pharmacy complies with federal law under Section 503A (traditional pharmacy) or Section 503B (FDA-registered outsourcing facility)
• The compounded formulation is not essentially a copy of an FDA-approved drug, unless the provider determines there is a significant difference that is medically necessary for the individual patient
• The drug appears on the FDA drug shortage list, when compounding would otherwise be limited by exclusivity or patent protections (especially relevant for 503B facilities)

The FDA considers it unlawful for a pharmacy to compound drugs that are essentially copies of commercially available products unless the licensed medical prescriber documents a meaningful clinical difference.

Because compounded semaglutide is not FDA-approved, it is not subject to the same manufacturing standards, pre-market review, or labeling requirements as branded medications. Its safety and efficacy depend on the practices of the compounding pharmacy and the clinical oversight of a licensed healthcare provider.

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Cost and Access Considerations

Access to semaglutide-based treatments may be influenced by factors such as pricing, insurance coverage, and the availability of commercially manufactured products. In some cases, compounded formulations may offer a lower-cost alternative — but these options should only be pursued when clinically appropriate and legally permitted.

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Prices are approximate and may vary based on pharmacy, dosage, region, and formulation. Patients should discuss cost, insurance eligibility, and available options with a licensed healthcare provider.

While affordability is a significant concern for many patients, cost should never override considerations of safety, legality, or clinical appropriateness. Compounded medications should be obtained only through qualified, licensed pharmacies and under the supervision of a licensed healthcare provider who can monitor treatment response and side effects.

Eden connects individuals with licensed healthcare providers who can evaluate their health needs and, when medically appropriate, refer them to pharmacies that meet federal and state compounding standards.

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Final Thoughts

Semaglutide is protected by a series of patents, some of which may extend into the 2030s, limiting the immediate availability of lower-cost generic alternatives. Branded products such as Ozempic® and Wegovy® are FDA-approved, meaning they have undergone rigorous testing for safety, efficacy, and manufacturing quality.

Compounded semaglutide formulations may be considered in certain situations, particularly when:

• A patient has a clinical need that cannot be met by commercially available options
• A licensed healthcare provider prescribes it based on medical necessity
• The compounding pharmacy operates in compliance with applicable federal and state laws

It is essential to understand that compounded semaglutide is not FDA-approved and is not equivalent to branded medications in terms of standardization, quality control, or regulatory oversight. Any use of a compounded formulation should involve:

• A licensed healthcare provider who can determine clinical appropriateness and monitor ongoing treatment
• A state-licensed pharmacy, ideally registered with the FDA if operating as a 503B outsourcing facility
• Transparency around ingredient sourcing, sterility protocols, and formulation standards

Eden helps individuals connect with licensed healthcare providers who can assess treatment options and, when medically and legally appropriate, refer to qualified compounding pharmacies.

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This article is for educational purposes only and does not constitute medical or legal advice. Always consult a licensed healthcare provider before making treatment decisions.