In clinics across high-income countries, the treatment of type 2 diabetes has entered a new era. Once-weekly injectable drugs like Novo Nordisk’s Ozempic (semaglutide) and Eli Lilly’s Mounjaro (tirzepatide) are doing more than lowering blood sugar — they are helping patients lose weight, reduce cardiovascular risk, and delay complications.

But for the vast majority of people with diabetes — in low- and middle-income countries (LMICs) — this promise of more effective treatment remains elusive, fenced off by layers of patents that keep prices sky-high.

The World Health Organization is weighing whether to add glucagon-like peptide-1receptor agonists (GLP-1 RAs) to its Model List of Essential Medicines (EML) this year. Listing would encourage pooled procurement and inclusion in national guidelines — a step that would support LMIC governments in procuring and offering them through public systems. But even if the WHO deems GLP-1 RAs clinically essential, it won’t matter unless they’re also affordable and available.

The gatekeeper here is affordability. Cost analyses show semaglutide could be manufactured for under $6 a month if generic competition entered the supply chain. Instead, prices hover at $100–300 per pen in many middle-income markets.Generic manufacturers could even offer pre-filled syringes to tide over the shortage of delivery devices such as pens in resource poor settings.

Why so expensive?

GLP-1 RAs are priced out of reach in most countries because pharma corporations are filing patents to extend monopolies past the expiration of the original compound patents. This practice, called “evergreening”, is a tactic to block competition.

Novo Nordisk has at least 70 patents in the US (and dozens elsewhere) on semaglutide, covering everything from injection devices to once-weekly dosing — even though the core compound patent expires in 2026. Lilly’s compound patent on tirzepatide lasts until 2036, but the firm is pursuing follow-on patents to push exclusivity to 2043. None of these secondary claims represent breakthrough science. It’s a strategy to stretch monopolies.

That strategy is now colliding with Indian pharma industry’s ambition to produce affordable generics of Ozempic for domestic sale and export to other LMICs. Think back to Cipla and Natco challenging HIV and cancer drug monopolies at the turn of the century.

In 2025, the decisive front line is the Delhi High Court.

In May 2025, Danish corporation Novo Nordisk sued Hyderabad-based Dr Reddy’s Laboratories (DRL), seeking an injunction to block its semaglutide product. In the next hearing, if DRL prevails and the patent is revoked — or narrowed — Indian manufacturers could launch generic semaglutide months before the 2026 compound expiry, triggering price-slashing competition across LMICs. A win for Novo, by contrast, would embolden the Danish corporation to sue generic manufacturers.

The stakes extend beyond semaglutide. Lilly is expected to mirror Novo’s legal tactics. Delhi’s rulings will therefore signal whether India remains committed to affordable access for patients and balances patent enforcement with public interest.

For patients in countries where diabetes incidence is soaring but public health budgets are thin, the outcome could mean the difference between timely access or waiting for insulin-sparing regimens. Courts, not clinicians, will decide how fast that future arrives.

The writer is a lawyer specialising in public health and intellectual property. Views are personal)

Published on June 15, 2025