Two Frontiers of Pharmaceutical Exclusivity: What Retatrutide and Semaglutide Tell Us About Protecting a Drug Across Its Lifecycle

By Lucy Rana and Huda Jafri

Eli Lilly is in court over a drug that isn’t on the market yet. Novo Nordisk is in court over one whose main patent has run out. Put the two stories side by side and you can see the whole shape of pharmaceutical exclusivity, and why, in India, protecting a molecule takes a good deal more than a patent.

A black market for a medicine that doesn’t exist yet

Most drug companies spend years planning for the day their molecule finally reaches patients. Lilly is spending money defending one that hasn’t got there. The company has reportedly filed six fresh lawsuits in the United States against businesses it says are selling retatrutide, its experimental triple agonist, which acts on the GIP, GLP-1 and glucagon receptors. The awkward part: retatrutide is still in Phase 3, and it has not been approved anywhere. Even so, copies are apparently already changing hands through compounding pharmacies, peptide sellers, medical spas and online stores. Some are stamped “research use only” while, Lilly alleges, being sold for people to inject. The company says it has referred more than 200 sellers to regulators, and it wants social-media platforms, payment processors and couriers to help close the trade down.

Behind the details sits a commercial fact worth pausing on. Demand for the next wave of weight-loss drugs has grown so intense that an illegal market has formed to sell the innovation before the regulator has even finished looking at it. Enforcement built for counterfeits of approved medicines was never designed for that, and it changes what “protecting a molecule” has to mean.

Same drug story, opposite ends of the timeline

The retatrutide fight makes most sense next to its mirror image. Novo Nordisk’s semaglutide sits at the far end of the same journey: the compound patent has reportedly run its course, generics are lining up, and the contest has moved to formulation, devices and brand. Lilly’s problem is the reverse. Its drug is years from launch, and it is already in court against people selling it.

One drug is too early for the market. The other is arguably past the peak of its protection. Between them they trace the two points where exclusivity is really decided: the pre-market phase and the post-patent phase, and they land on the same lesson. The compound patent is the middle of the story, not the end of it.

Frontier one: enforcing before approval

An unapproved drug can’t lawfully be sold to patients, which is exactly what makes an early black market so hard to police. There is no approved product to measure the fake against, no official label to judge the mislabelling by, and no legitimate supply chain that has been broken into. What the originator is really guarding is its route to market as much as the compound itself.

How this plays out in the United States

Suits like Lilly’s usually lean on trademark and unfair-competition claims, including false association, false advertising, and sellers borrowing the innovator’s name to look legitimate, propped up by state consumer-protection law and pressure through the FDA. The “research use only” tag does a lot of the work here. Sellers treat it as a way out: not sold for human use, so not really a drug. The moment the same vial is plainly marketed for people to inject, that line tends to read as proof of what they intended, rather than as a defence.

How India would handle the same thing

If unapproved retatrutide surfaced here for human use, an originator would have a good deal more than its patent to reach for.

• The drugs law bites first, with or without IP. An investigational drug can only be used inside an approved clinical trial. Make it, sell it, stock it or hand it out for human use and you are squarely within the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019, with penal consequences attached. The “research use only” wrapper does not survive contact with a product that is actually being sold to patients.
• Then the patent. If the originator holds, or is prosecuting, an Indian patent on the molecule, Section 48 of the Patents Act, 1970 gives it the right to stop others making, using, selling or importing it. The Delhi High Court in particular is comfortable granting quia timet injunctions, which restrain an infringement that is threatened but has not yet happened. That fits a pre-launch black market almost exactly.
• Don’t overlook the brand. The product name and house marks can be defended under the Trade Marks Act, 1999, including well-known-mark protection, even before launch, where a seller’s use of the name is dishonest or trades on the innovator’s reputation.
• Finally, the hard part: anonymous sellers. Most of this trade is online and pseudonymous. John Doe (“Ashok Kumar”) orders, dynamic injunctions, intermediary takedowns and pressure on payment and shipping chokepoints let a rights-holder move against people it cannot yet name, the local version of Lilly leaning on platforms and couriers.

Frontier two: exclusivity after the compound patent

If retatrutide shows how early protection can start, semaglutide shows how long it can run. People describe the compound patent expiring as a cliff. It is closer to a second round than a final whistle.

Secondary patents, and where India draws the line

Originators stack patents around a molecule: formulation, salt and polymorph, dosing regimen, and the delivery device, the pre-filled pen being the obvious one in this class. Those can stretch real-world exclusivity well past the compound patent. India, though, is deliberately hard on this. Section 3(d) refuses patents on new forms of a known substance unless they show a real gain in therapeutic efficacy, the line the Supreme Court held in the Novartis (Glivec) case[1]. So secondary patents do exist here, but they sit more exposed to challenge than in many other markets, and you cannot bank on them holding.

The brand outlives the patent

Goodwill doesn’t expire when a patent does. Names such as Ozempic, Wegovy and Rybelsus, and the distinctive look of the injector pens, stay protectable for as long as they are used, through trademark, trade dress and passing off. Novo Nordisk is currently litigating exactly that point in the Delhi High Court, where it has accused Dr. Reddy’s Laboratories of adopting the mark “Olymviq” for a semaglutide injection that it says is structurally and phonetically similar to “Ozempic”[2]. Dr. Reddy’s has argued that it markets the product under its own well-known house mark and in different packaging, and that a prescription-only product is not bought on impulse in the way that might otherwise matter to confusion. The court has so far declined to grant an interim injunction or rule on the merits, though it has observed that the two marks “do seem phonetically similar” on the material before it and has invited the parties to explore an amicable rebranding; Dr. Reddy’s has given an undertaking to maintain the status quo pending further hearings. As generics arrive, the originator’s enforcement usually shifts from “you can’t make this molecule” to “you can’t dress your product up as ours.” In a category people buy largely on brand recognition, that shift matters commercially.

The race to launch

Novo Nordisk’s Indian compound patent on injectable semaglutide (Indian Patent No. 262697) expired in March 2026, opening the door to injectable generics. The contest since then has run through the separate formulation patent Novo Nordisk holds over the oral tablet (Indian Patent No. 325669), whose claim 1 covers a 0.6 to 2.1 mmol range of SNAC (sodium N-[8-(2-hydroxybenzoyl)amino]caprylate), an absorption enhancer that makes the oral tablet bioavailable. The Delhi High Court has recorded an interim undertaking from Torrent Pharmaceuticals that its own tablets, whose SNAC content is reported at around 0.53 mmol, will stay outside that claimed range for both domestic and export purposes[3]. Dr. Reddy’s Laboratories has given a similar undertaking in a connected suit over the same patent[4]. Most recently, on 11 August 2026, the court directed Sun Pharmaceutical Industries, currently the second-largest generic semaglutide player in India after Torrent, that if and when it receives a commercial manufacturing licence for its own tablets, it must return to court for approval before taking any further steps toward a launch. None of the three has yet been cleared to launch tablets in India: the compound patent’s expiry has opened the door to injectable generics, but the tablet formulation patent is still very much being fought over.

Why India makes the layered approach non-negotiable

Three features of the Indian system explain why no single right is enough.

• There is no regulatory data exclusivity. The United States (Hatch-Waxman) and the European Union (its 8+2+1 rule) each give an originator a stretch of protection over its clinical data. India does not. There is no statutory bridge to carry you over a gap in patent cover, so the weight lands on patents, trademarks and regulatory enforcement instead.
• The patentability bar is high. Section 3(d), together with a demanding examination and opposition regime, makes secondary-patent “evergreening” harder to pull off, which trims the tail of exclusivity that originators enjoy elsewhere.
• The runway favours generics. The Bolar-type exemption in Section 107A lets a generic do its development and regulatory groundwork before the patent expires, so competitors tend to be ready on day one, with compulsory licensing sitting in the background for anything in very high demand.

Put together, exclusivity in India isn’t something you inherit from one patent grant. You build it, right by right, across the life of the product.

What this means in practice

• Map the IP to the lifecycle from the moment you pick the candidate. Decide early which layer (compound, formulation, device, dosing, brand) carries exclusivity at each stage, and where Section 3(d) is going to bite.
• Protect the brand before you need it. File the name and start building well-known-mark evidence ahead of launch, so both pre-market and post-patent enforcement have something to stand on.
• Keep a pre-launch enforcement plan ready. Pair quia timet patent relief with John Doe and dynamic injunctions, customs recordal, and pressure on intermediaries, payments and logistics, and run a drug-regulatory complaint alongside every IP action, because the regulator often moves faster.
• Treat counterfeits as a reputation problem, not only a clinical one. Adverse events from unauthorised material get muddled in public with the safety record of the real investigational drug. That is a legal and PR exposure, and enforcement strategy should say so out loud.
• If you’re a generic or an investor, diligence the whole stack. Compound-patent expiry is a headline, not a green light. Freedom-to-operate has to cover secondary patents, device rights and brand risk before anyone fixes a launch date or a valuation.

The molecule is only the start

Retatrutide and semaglutide look like opposite stories: one too early, one arguably too late. They are really the same story read from two ends. Protecting a drug now runs from before approval to well after the main patent is gone, and the companies that keep their ground are the ones that treat IP as a series of defences timed to the market’s own clock, rather than a single wall around a compound. In India, with no data-exclusivity cushion and a high bar on patents, that is not a nice-to-have. It is the whole game.

[1] Novartis AG v. Union of India, (2013) 6 SCC 1.

[2] Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd., CS(COMM) 317/2026, Delhi High Court

[3] Novo Nordisk A/S v. Torrent Pharmaceuticals Ltd., Delhi High Court, interim order dated 20 March 2026

[4] Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd. (patent suit concerning Indian Patent No. 325669),

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