# Novo Nordisk's Post-Patent Strategy **Author:** Philipp D. Dubach | **Published:** June 29, 2025 | **Updated:** February 23, 2026 **Categories:** Medicine **Keywords:** amycretin weight loss, Novo Nordisk pipeline, Ozempic patent expiration, amycretin vs Wegovy, Novo Nordisk stock analysis ## Key Takeaways - Amycretin delivered 24.3% average weight loss in Phase 1, beating both Wegovy at 15% and Zepbound at 22.5%, with dose-response curves that overlapped across groups. - Novo Nordisk's core Ozempic patent expires December 2031, but complex peptide manufacturing and patented injection devices create a capacity constraint moat that generic competitors cannot quickly replicate. - The oral amycretin version hit 13.1% weight loss in just 12 weeks with patients still losing weight when the trial ended. - Novo is down 48% year-over-year, with Martin Shkreli's model putting fair value at 705 DKK, roughly 21% upside from current levels. --- Novo Nordisk, a long time member of my "regrets" stock list, has become [reasonably affordable lately (-48% yoy)](https://finance.yahoo.com/quote/NVO/chart/). Part of the reason being that they currently sit atop a ~$20 billion Ozempic/Wegovy franchise that faces [patent expiration in 2031](https://journals.library.columbia.edu/index.php/stlr/blog/view/653). That's roughly seven years to replace their blockbuster drug. We revisit them today, since per [newly published Lancet data](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01185-7/fulltext), Novo's lead replacement candidate—amycretin—just posted some genuinely impressive Phase 1 results. The injectable version delivered [24.3% average weight loss versus 1.1% for placebo](https://www.thelancet.com/cms/10.1016/S0140-6736(25)01185-7/asset/6f4ec048-c12e-4185-a860-a2dc988746c4/main.assets/gr3_lrg.jpg), beating both current market leaders (Wegovy at 15% and Lilly's Zepbound at 22.5%). Even the oral version hit 13.1% weight loss in just 12 weeks, with patients still losing weight when the trial ended. Amycretin is very elegantly designed: It combines semaglutide (the active ingredient in Ozempic/Wegovy) with amylin, creating what's essentially a dual-pathway satiety signal. Semaglutide activates GLP-1 receptors to slow gastric emptying and reduce appetite centrally, while amylin works through complementary mechanisms to enhance fullness signals. This way both your stomach and your brain's "appetite control center" are getting the "stop eating" message simultaneously. One concern raised by [Elaine Chen at STAT](https://www.statnews.com/staff/elaine-chen/) is that the [results of a Phase 1/2 study include unusual findings around dosage](https://www.statnews.com/2025/06/20/novo-nordisk-weight-loss-drug-amylin-hormone-injection-effective-but-side-effects-an-issue/). The full text article is behind a paywall unfortunately, so I did not have access. However, looking at the actual data from the study, I am assuming she is referring to Parts C, D, and E, which tested maintenance doses of 20 mg, 5 mg, and 1.25 mg respectively. The weight loss results were: > Part C (20 mg): -22.0% weight loss at 36 weeks
Part D (5 mg): -16.2% weight loss at 28 weeks
Part E (1.25 mg): -9.7% weight loss at 20 weeks While there is a dose-response relationship, what's notable is the curves in [Figure 3](https://www.thelancet.com/cms/10.1016/S0140-6736(25)01185-7/asset/6f4ec048-c12e-4185-a860-a2dc988746c4/main.assets/gr3_lrg.jpg) show relatively similar trajectories during the overlapping time periods. Typically in drug development, researchers would expect clear separation between dose groups (with higher doses producing proportionally greater effects). When weight-loss curves overlap significantly (which they do in this case), it suggests the doses may be producing similar effects despite different drug concentrations. If lower doses produce similar weight loss with potentially fewer side effects, this could favor using the lower, better-tolerated dose. Further, it might indicate that amycretin reaches maximum effect at relatively low doses. This should probably influence how future Phase 3 trials are designed, potentially focusing on the optimal dose rather than the maximum tolerated dose. Given that gastrointestinal side effects were dose-dependent but efficacy curves overlapped, this supports using the lowest effective dose. How that might be a bad thing I have yet to find out. From a financial perspective, [Novo Nordisk's pipeline](https://www.novonordisk.com/science-and-technology/r-d-pipeline.html) is very interesting: Amycretin's injectable version is currently in Phase 2, suggesting Phase 3 trials around 2026-2027, with potential approval by 2031; basically right as the Ozempic patents expire. But Novo isn't betting everything on amycretin. They're running what appears to be a diversified pipeline strategy with multiple shots on goal: [NNC-0519](https://www.novonordisk-trials.com/trials-conditions/all-trials-v2/NN9541-4919.html) (another next-gen GLP-1), [NNC-0662](https://www.novonordisk-trials.com/trials-conditions/all-trials-v2/NN9662-7694.html) (details kept confidential), and cagrilintide combinations. This makes sense: you want multiple candidates because the [failure rate in drug development](https://pmc.ncbi.nlm.nih.gov/articles/PMC9293739/) makes even the most promising compounds statistically likely to fail. Eli Lilly's tirzepatide (Mounjaro/Zepbound) [works through a different mechanism](https://mounjaro.lilly.com/hcp/how-mounjaro-works)—GLP-1 plus GIP receptor activation—and appears to be gaining market share. [Lilly's orforglipron, an oral GLP-1 that hit 14.7% weight loss in Phase 2](https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statistically), represents another competitive threat. Judging by [LLY's price development](https://finance.yahoo.com/quote/LLY/chart/), investors currently seem to think that Lilly is doing a better job at architecting a portfolio than Novo (or at least providing more disclosure about their pipeline). Yet, the overall competitive landscape might actually benefit both companies. The "war" between Novo and Lilly is expanding the overall market for obesity treatments, potentially growing the pie faster than either company is losing share. Also, to analyze the financial impact of the expiring Ozempic patents, we have to look further than just Novo's research pipeline. Manufacturing these GLP-1 compounds and their [delivery devices](https://yds.ypsomed.com/files/media/03_Documents/12_Articles/%23171_2025_AprMay_Sustainability_Ypsomed.pdf) is "pretty tough." Complex peptides requiring [specialized manufacturing capabilities](https://www.bachem.com/articles/commercial-apis/glucagon-like-peptide-1-glp-1/), plus the injection devices themselves are patent-protected. This creates what we would call [a capacity constraint moat](https://www.morganstanley.com/im/publication/insights/articles/article_measuringthemoat.pdf) in corporate strategy. Novo's manufacturing capabilities/partnerships and injectable device patents are a key competitive advantage. Even when semaglutide goes generic in 2031, the entire generic pharmaceutical industry would essentially need to coordinate to build sufficient manufacturing capacity to meaningfully dent Novo's market share. Meanwhile, Novo could potentially defend by lowering prices while maintaining manufacturing advantages in a monopoly-to-oligopoly transition. The other day I came across [Martin Shkreli's NOVO model](https://github.com/martinshkreli/models/blob/main/NOVOB.xlsx). Conservatively, it puts Novo's fair value around 705 DKK (21% upside from ~585 DKK), while a failure scenario drops valuation to 385 DKK. The range reflects what you'd expect for a large-cap pharmaceutical company;the market has already incorporated most knowable information about pipeline risks and patent timelines. This also underscores the point that manufacturing capabilities and continuous innovation pipelines can potentially maintain quasi-monopolistic positions longer than traditional patent protection would suggest. Shkreli's analysis suggests Novo Nordisk is reasonably valued with modest upside potential, contingent on successful pipeline execution. Novo Nordisk is at a critical juncture, with substantial franchise value dependent on successful pipeline execution over the next 7-8 years. While the current valuation appears reasonable, the binary nature of drug development success creates both upside potential and significant downside risk. _
This article is for informational purposes only, you should not consider any information or other material on this site as investment, financial, or other advice. There are risks associated with investing.
_ --- ## Frequently Asked Questions ### How much weight loss does amycretin achieve compared to Wegovy and Zepbound? In Phase 1b/2a trials published in The Lancet, injectable amycretin delivered 24.3% average weight loss at the highest dose over 36 weeks, compared to 1.1% for placebo. This outperforms both Wegovy (approximately 15% weight loss) and Eli Lilly's Zepbound (approximately 22.5%). The oral version achieved 13.1% weight loss in just 12 weeks, with patients still losing weight when the trial ended. ### How does amycretin work differently from semaglutide (Ozempic/Wegovy)? Amycretin is a dual-pathway drug that combines semaglutide's GLP-1 receptor activation with amylin receptor agonism. While semaglutide alone slows gastric emptying and reduces appetite through GLP-1 signaling, amycretin adds amylin's complementary satiety signals, meaning both the gut and the brain's appetite control center receive simultaneous "stop eating" messages. This dual mechanism explains the greater weight loss observed in trials. ### When will amycretin be FDA approved and available? Amycretin's injectable version completed Phase 1b/2a trials in 2025, with Phase 3 trials expected to begin in 2026. Based on typical drug development timelines, FDA approval could come around 2030-2031, aligning with the expiration of Ozempic's core US patent in December 2031. Novo Nordisk has not announced a specific target approval date. ### What happens to Novo Nordisk when the Ozempic patent expires? Ozempic's core US patent expires in December 2031, but Novo Nordisk has multiple defenses. Manufacturing GLP-1 compounds requires specialized peptide production capabilities and patented injection devices that create a significant capacity constraint. Even after patent expiration, generic manufacturers would need years to build sufficient manufacturing infrastructure, giving Novo time to transition patients to next-generation drugs like amycretin while potentially lowering prices to maintain market share. ### What does amycretin's dose-response data tell us about future trials? The Phase 1b/2a data showed overlapping weight-loss curves across different dose groups (20 mg: -22.0%, 5 mg: -16.2%, 1.25 mg: -9.7%), suggesting amycretin may reach its maximum effect at relatively low doses. Since gastrointestinal side effects were dose-dependent but efficacy curves overlapped, this supports using the lowest effective dose in Phase 3 trials, which could improve tolerability while maintaining strong weight-loss results. --- *Philipp D. Dubach — [http://philippdubach.com/](http://philippdubach.com/) — 2025*