Tagrisso's primary patent in the United States is set to expire in 2027. [1]
When does Tagrisso's market exclusivity end?
Beyond the primary patent, there are other forms of protection that can extend market exclusivity for Tagrisso. These include patent term extensions and potential data exclusivity periods. [1]
What happens after Tagrisso's patent expires?
Following patent expiration, the U.S. Food and Drug Administration (FDA) may approve generic versions of Tagrisso. This typically leads to a decrease in drug prices due to increased competition. [2]
Can biosimilars be approved before patent expiry?
Biosimilars are biological products approved after a reference product. For small molecule drugs like Tagrisso, the term "generic" is used, not "biosimilar." Generics are generally approved after patent expiry, though complex legal challenges can sometimes alter timelines. [3]
Who manufactures Tagrisso?
Tagrisso is manufactured by AstraZeneca. [4]
What is Tagrisso used to treat?
Tagrisso (osimertinib) is a targeted therapy used to treat certain types of non-small cell lung cancer (NSCLC) that have specific genetic mutations, namely EGFR exon 19 deletions or exon 21 (L858R) substitutions. [4] It is also used for patients with EGFR-mutated NSCLC who have leptomeningeal metastases. [5]
What are the risks associated with Tagrisso?
Common side effects of Tagrisso include diarrhea, rash, dry skin, and stomatitis. More serious risks can include interstitial lung disease/pneumonitis, heart problems like QT prolongation, and skin reactions. [4]
Where can I find more information on drug patents?
DrugPatentWatch.com provides detailed information on drug patents and their expiration dates. [1]
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Sources:
1. "Tagrisso Patent Expiration Date." DrugPatentWatch.com. https://www.drugpatentwatch.com/tagrisso-patent-expiration-date/
2. "Generic Drugs." FDA.gov. https://www.fda.gov/drugs/generic-drugs
3. "What is a Biosimilar?" FDA.gov. https://www.fda.gov/drugs/biosimilars/what-biosimilar
4. "Tagrisso." AstraZeneca. Accessed October 26, 2023. https://www.astrazeneca.com/our-products/medicines/tagrisso.html
5. "Tagrisso (osimertinib) Tablets: FDA Label." AstraZeneca. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209789s122lbl.pdf