Generic Mounjaro: When will it be available?

A generic medication is a treatment that contains the same active ingredient, in the same strength and form, as an already approved branded version. For Mounjaro, this would mean a generic tirzepatide injection that matches the dose and effect of the original product.

Before a generic version of a medication can be offered in the UK, it must be approved by the Medicines and Healthcare products Regulatory Agency (MHRA). To gain approval, the manufacturer must show that the generic is the same as the branded medicine. This means it delivers the same levels of the drug in the blood, works in the same way, and is expected to provide the same safety and effectiveness.

What is Mounjaro’s generic name?

The Mounjaro generic name is tirzepatide. Mounjaro is the brand name used by the manufacturer, while tirzepatide is the ‘international non-proprietary name’ (INN) that refers to the active ingredient itself.

When a new medication is launched, the company that developed it is given legal protection to stop others from copying it straight away. The main protection is a patent, which normally lasts up to 20 years. This can sometimes be extended by up to 5 years with a Supplementary Protection Certificate (SPC). These rights give the manufacturer time to cover the costs of research and development.

In addition to patents, medications in the UK and EU also follow what is known as the “8+2+1” rule. This means 8 years where generic companies cannot use the original trial data, followed by 2 years where they still cannot sell a copy. In some cases, there can be an extra year of protection for new uses of the medicine.

To put this into context, liraglutide (Saxenda) has already lost patent protection, and generic versions are beginning to reach the UK market, such as Nevolat.

Wegovy (semaglutide) is expected to lose exclusivity around 2028, while Mounjaro (tirzepatide) is not expected to come off patent until around 2032.

Mounjaro is expected to come off patent in 2032, but when it becomes available as a generic will also depend on how quickly regulatory approvals are granted. At present, only Eli Lilly, the manufacturer of Mounjaro, is permitted to market tirzepatide in the UK.

The main factors affecting the availability of generic Mounjaro include:

1. Patent expiry – the patent and any Supplementary Protection Certificates (SPCs) must end before generics can be launched.
2. Data and market exclusivity – under EU and UK rules, there is an 8+2+1 year system that prevents competitors from using the original trial data and marketing a new product for a set period.
3. Regulatory approval – once protections expire, generic manufacturers must still show their version is equivalent and safe before it can be sold.

Generic medications are usually cheaper than their branded versions because multiple companies can make and sell them once patents expire. This increased competition helps lower prices.

The exact cost of a generic version of Mounjaro would depend on:

• the number of generic suppliers entering the market
• manufacturing and supply costs
• whether the medication is provided through the NHS or private clinics

If approved for NHS use, the price would likely be negotiated to keep costs down for the health service, and the medication would be available to patients for the standard prescription fee. In private clinics, prices may vary depending on the provider and demand.

Generic medications must meet strict standards before they can be approved in the UK. The MHRA requires evidence that the generic is ‘bioequivalent’ to the branded medicine, meaning it delivers the same active ingredient in the same way.

Manufacturers must also prove their product meets high-quality standards in terms of production and safety. Because of these checks, patients can expect the same clinical effect and safety profile from a licensed generic as from the original branded medication.

While generic Mounjaro is not yet available, there are other licensed options for weight management in the UK. These include:

• Wegovy (semaglutide) – another GLP-1 medication taken as a weekly injection
• Nevolat (liraglutide) – a daily GLP-1 injection and generic medication, formerly known as Saxenda
• weight loss tablets – examples include orlistat (Xenical), Mysimba, or the over-the-counter orlistat options, alli or Orlos
• lifestyle programmes – structured diet and exercise support, which must also be followed alongside any medical treatment
• weight loss surgery – can be accessed privately or through the NHS for people with a higher BMI, usually around 40 or more, and involves making the stomach smaller so you are permanently fuller