Patently Not Obvious!
There was Viagra, then Lipitor, let’s not forget Plavix, and more recently Humira. Not just blockbusters, but “mega products” each with cumulative sales in excess of US$50 billion. Few would be surprised if Lilly’s Mounjaro (approved for type 2 diabetes and obesity) were to be added to the list given current usage and predicted levels of demand.
Blockbusters attract significant interest from the generic sector and the race will be on to launch the first generic version of Mounjaro...
... but the, quite literally, billion-dollar question is “when will that be?” For those hoping that 2027’s expiry of Lilly’s New Chemical Entity (NCE) US-exclusivity for tirzepatide (Mounjaro’s active ingredient), means a generic is not far behind are, however, going to be disappointed. An extensive patent “thicket” will likely extend Lilly’s protection out to 2041.
While the ending of Lilly’s NCE exclusivity may allow for the filing of generic applications, Lilly’s patent on tirzepatide active substance is not scheduled to expire until 2036. That is the fundamental hurdle, but it is not the only one. Other patents protect specific medicinal formulations; a key one (US Patent 11,357,820/EP3810201) and facilitating product safety and patient comfort at the injection site is set to expire in 2039. Further patents (e.g. US Patent 12,295,987/ EP3678096) focus on dosing regimens and provide additional protection to 2041. Add in protection of production processes, packaging and delivery devices, and Lilly may well achieve those anticipated mega sales.
However, navigating the minefield which is pharmaceutical intellectual property requires not only highly specialised technical expertise, it is no less a matter of sophisticated commercial judgement. When patent expiries finally enable generics to enter the market, the price erosion of some medicines, 80% is not untypical, begs the question as to whether the development effort is simply worth it.
Compared to originator prices, generic versions of Viagra (sildenafil), Lipitor (atorvastatin), Plavix (clopidogrel) all launched at discounts of more than 80%. Within that overall cost-benefit assessment, those responsible for developing the actual generic formulations will be aware that as a long peptide chain, tirzepatide is prone to degradation and so poses costly challenges in ensuring a final product that is stable and maintains potency and shelf-life.
The approach on whether to proceed with a generic version of a blockbuster is multi-layered. Originator patents may be at the core, but regulatory timing, primary and secondary manufacturing complexity, financial viability, and new product developments (Lilly already has retatrutide in clinical trials as a potential follow-on) are just some of the factors that determine the final decision.
Surfachem’s understanding of the strategic intelligence that informs these decisions is what underpins our support to customers who need to develop the right products and at the right time. Our Intelligent Distribution is not just a matter of excellence today; it’s having the expertise to provide value for the future.
Sources used in preparation of this article:
- British Generic Manufacturers Association Medicines UK - Home
- Coherent Market Reports
- Drug Patent Watch Our search for a reliable patent intelligence solution ended with DrugPatentWatch
- Eli Lilly Annual Report 2024
- European Patent Office Homepage | epo.org
- Pharma Times PharmaTimes | in-depth news, features and insights for the pharmaceutical and healthcare sectors
- Pulse Today GP news, articles, views and learning | Pulse Today
Disclaimer: This information is for guidance purposes only and does not constitute legal, business, financial, or other professional advice, nor should it be relied upon for any IP-related, business, or other decision-making. The provider is not responsible for any use made of this information, and appropriate professional legal advice should be sought. We aim for accuracy but accept no responsibility for errors or omissions.
