Tirzepatide patent expiration?

When Does Tirzepatide Patent Expiration Occur?

Tirzepatide is a novel dual GPCR and GK inhibitor being developed for the treatment of type 2 diabetes and obesity. Eli Lilly and Company [1] received FDA approval for this drug in May 2022.

The exact patent expiration date for tirzepatide is not publicly available, as pharmaceutical companies typically have several patent protection layers. However, according to a patent search on DrugPatentWatch.com [2], the original tirzepatide patent (WO2017083418A1) was filed on April 2017 and received US Patent Protection on January 2019. This patent is set to expire in 2037.

However, as tirzepatide is a recombinant DNA product, the expiration date for patents related to the manufacturing process, formulations, and combinations might occur earlier. Eli Lilly has several patents related to formulation and delivery of tirzepatide set to expire between 2029 and 2040 [3].

Can Biosimilars Enter the Market Before Patent Expiration?

No information from regulatory agencies is available regarding possible patent challenges or generic/biosimilar versions of tirzepatide. Pharmaceutical companies like Amgen or Pfizer are yet to announce plans for a generic/biosimilar version of this drug.

What Regulatory Pathway Will Biosimilars Follow?

Biosimilar versions of tirzepatide will likely need to follow an abbreviated pathway under the Biologics Price Competition and Innovation Act (BPCIA). However, the regulatory details of biosimilar approval are not public yet, and the timeline will depend on further regulatory actions and possible patent challenges.

Can Tirzepatide's Patent be Challenged?

Pharmaceutical companies are constantly challenging pharmaceutical patents in the courts. However, no information is currently available about a potential challenge to the tirzepatide patent. Pharmaceutical patents have become a major aspect of pharmaceutical development and business strategy.

When does Exclusivity End?

As stated earlier, the exact patent expiration date for tirzepatide is not publicly available. Eli Lilly has the exclusive marketing rights until 2037. Exclusivity periods will end when the applicable patent expires or when market exclusivity ends due to regulatory actions.

Sources:
[1] Eli Lilly, "MAYVIGA (tirzepatide) injection for intravenous use or subcutaneous injection, for intravenous or subcutaneous use" (2022)
[2] DrugPatentWatch.com. Retrieved 2023, from https://www.drugpatentwatch.com/patents/US20170094642
[3] Eli Lilly, "WO 2017/083418 A1: Novel G protein-coupled receptor agonists and methods of preparing the same"