Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Colorcon
Express Scripts
Moodys
Harvard Business School

Last Updated: January 30, 2023

Osimertinib mesylate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic sources for osimertinib mesylate and what is the scope of patent protection?

Osimertinib mesylate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Osimertinib mesylate has one hundred and seventy-one patent family members in forty-four countries.

There are two drug master file entries for osimertinib mesylate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for osimertinib mesylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Phase 1/Phase 2
Wuhan Union Hospital, ChinaPhase 2
Sichuan Baili Pharmaceutical Co., Ltd.Phase 2/Phase 3

See all osimertinib mesylate clinical trials

Generic filers with tentative approvals for OSIMERTINIB MESYLATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing80MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing40MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for OSIMERTINIB MESYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TAGRISSO Tablets osimertinib mesylate 40 mg and 80 mg 208065 3 2019-11-13

US Patents and Regulatory Information for osimertinib mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for osimertinib mesylate

Country Patent Number Title Estimated Expiration
South Korea 101422619 See Plans and Pricing
Peru 20141700 COMPUESTOS DE 2-(2,4,5-ANILINO SUSTITUIDO) PIRIMIDINA See Plans and Pricing
Spain 2873226 See Plans and Pricing
China 105175396 Substituted 4-methoxy-N3-(pyrimidine-2-yl)phenyl-1,3-diamine compound and salt thereof See Plans and Pricing
Japan 2013544273 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for osimertinib mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1848414 93160 Luxembourg See Plans and Pricing PRODUCT NAME: OSIMERTINIB (TAGRISSO); FIRST REGISTRATION DATE: 20160204
1848414 300824 Netherlands See Plans and Pricing PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204
1848414 CA 2016 00033 Denmark See Plans and Pricing PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204
1848414 132016000078445 Italy See Plans and Pricing PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204
1848414 122016000056 Germany See Plans and Pricing PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
AstraZeneca
Medtronic
Baxter
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.