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Tagrisso is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are three patents protecting this drug.
This drug has one hundred and thirty-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.
Indicators of Generic Entry
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
|Genprex, Inc.||Phase 1/Phase 2|
|National Cancer Institute (NCI)||Phase 3|
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences||Phase 2|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Astrazeneca Pharms||TAGRISSO||osimertinib mesylate||TABLET;ORAL||208065-001||Nov 13, 2015||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|Astrazeneca Pharms||TAGRISSO||osimertinib mesylate||TABLET;ORAL||208065-002||Nov 13, 2015||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Astrazeneca Pharms||TAGRISSO||osimertinib mesylate||TABLET;ORAL||208065-001||Nov 13, 2015||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|