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Tagrisso is a drug marketed by Astrazeneca and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and forty-eight patent family members in forty-two countries.
The generic ingredient in TAGRISSO is osimertinib mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the osimertinib mesylate profile page.
Tagrisso was eligible for patent challenges on November 13, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 2, 2035. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (osimertinib mesylate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for TAGRISSO
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||134|
|Drug Prices:||Drug price information for TAGRISSO|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for TAGRISSO|
|What excipients (inactive ingredients) are in TAGRISSO?||TAGRISSO excipients list|
|DailyMed Link:||TAGRISSO at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for TAGRISSO
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TAGRISSO
Identify potential brand extensions & 505(b)(2) entrants
|M.D. Anderson Cancer Center||Phase 1/Phase 2|
|Beijing Cancer Prevention & Treatment Society||Phase 2|
|Sun Yat-sen University||Phase 2|
Pharmacology for TAGRISSO
|Country||Patent Number||Estimated Expiration|
|Portugal||3333161||⤷ Try it Free|
|Ukraine||109736||⤷ Try it Free|
|South Korea||20140030089||⤷ Try it Free|
|Denmark||2736895||⤷ Try it Free|
|Japan||6588915||⤷ Try it Free|
|Mexico||2016008744||⤷ Try it Free|
|>Country||>Patent Number||>Estimated Expiration|