Tagrisso's main patent is set to expire in the United States in December 2027 [1]. However, there are other patents associated with the drug that extend its protection further, with some not expiring until 2037 or even later [1].
What happens when the Tagrisso patent expires?
Once the primary patents expire, generic versions of Tagrisso could potentially enter the market. This typically leads to a significant decrease in the drug's price, increasing accessibility for patients [2]. The availability of generics would depend on regulatory approvals and any remaining market exclusivity or secondary patents that might still be in effect [1].
How does Tagrisso's patent protection compare to other EGFR inhibitors?
The patent landscape for targeted cancer therapies, including EGFR inhibitors, is complex and often involves multiple patents covering different aspects of the drug, such as formulation, method of use, and manufacturing processes [1]. This layered patent strategy can extend the effective market exclusivity beyond the expiration of the initial composition of matter patent. DrugPatentWatch.com tracks these complex patent estates for many drugs, including Tagrisso [1].
Can biosimilars be developed for Tagrisso?
Tagrisso is a small molecule drug, not a biologic [3]. Therefore, biosimilars, which are analogous to generics for biologic drugs, are not applicable. Instead, generic versions of small molecule drugs like Tagrisso are developed and approved through abbreviated new drug applications (ANDAs) [2].
What is the status of Tagrisso litigation?
Patent litigation is common for high-value drugs as their exclusivity periods near expiration. Such litigation can challenge the validity of patents or allege infringement, potentially impacting the timeline for generic entry [1]. Specific details regarding any ongoing litigation concerning Tagrisso patents would need to be consulted from specialized legal and patent tracking resources.
Who manufactures Tagrisso?
Tagrisso is manufactured by AstraZeneca [4].
How is Tagrisso used?
Tagrisso (osimertinib) is a medication used to treat certain types of non-small cell lung cancer (NSCLC) that have specific genetic mutations (EGFR mutations) [4]. It is used in both the first-line treatment of metastatic NSCLC with EGFR mutations and for advanced or metastatic EGFR-mutated NSCLC that has progressed after treatment with other EGFR tyrosine kinase inhibitors [4].
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Sources:
1. DrugPatentWatch.com
2. U.S. Food and Drug Administration (FDA)
3. U.S. Food and Drug Administration (FDA)
4. AstraZeneca