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TAGRISSO

NDA

OSIMERTINIB MESYLATE | N208065 | ASTRAZENECA PHARMACEUTICALS LP

2 strengths5 unique patents3 unique exclusivities

Patent Timeline

5 unique patents, 3 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Aug. 8, 2032

Jul. 25, 2032

Jan. 2, 2035

Jul. 25, 2032

Nov. 26, 2042

I-941

Feb. 16, 2027

I-952

Sep. 25, 2027

ODE-337

Dec. 18, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP et al 1:2021cv01338 2 patentsosimertinib	D. Del.	2021-09-22	Terminated 2024-08-14	—
AstraZeneca AB et al v. Zydus Pharmaceuticals (USA), Inc. et al 1:2021cv00550 1 patentANDA 214263osimertinib mesylate	D. Del.	2021-04-16	Terminated 2021-11-15	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tagrisso (2023)

Total Spending

$1.2B

Total Claims

70,847

Beneficiaries

9,387

Avg Cost/Unit

$569.45

Spending Trend

$640.7M(2019)→$793.5M(2020)→$913.3M(2021)→$1.1B(2022)→$1.2B(2023)

YoY Change:+4.0%

5yr CAGR:+2.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDOSIMERTINIB MESYLATE

DMF 321432017

ALEMBIC PHARMACEUTICALS LTDOSIMERTINIB MESYLATE

DMF 334092018

HETERO LABS LTDOSIMERTINIB MESYLATE

DMF 355812021

SCINOPHARM TAIWAN LTDOSIMERTINIB MESYLATE

DMF 365462021

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Sep 26, 2024	SUPPL -33	View Letter (PDF)
Apr 30, 2024	SUPPL -31	View Letter (PDF)
Feb 20, 2024	SUPPL -30	View Letter (PDF)
Feb 1, 2024	SUPPL -29	View Letter (PDF)
Jun 22, 2023	SUPPL -28	View Letter (PDF)
Oct 24, 2022	SUPPL -27	View Letter (PDF)
Oct 3, 2022	SUPPL -26	View Letter (PDF)
Jan 20, 2022	SUPPL -25	View Letter (PDF)
Jul 27, 2021	SUPPL -22	View Letter (PDF)
Dec 22, 2020	SUPPL -21	View Letter (PDF)
Dec 15, 2020	SUPPL -19	View Letter (PDF)
Dec 10, 2020	SUPPL -18	View Letter (PDF)
Jun 2, 2020	SUPPL -16	View Letter (PDF)
Dec 23, 2019	SUPPL -13	View Letter (PDF)
Aug 30, 2018	SUPPL -11	View Letter (PDF)
Apr 23, 2018	SUPPL -9	View Letter (PDF)
Apr 23, 2018	SUPPL -8	View Letter (PDF)
Nov 6, 2017	SUPPL -7	View Letter (PDF)
Apr 3, 2017	SUPPL -6	View Letter (PDF)
Sep 30, 2016	SUPPL -3	View Letter (PDF)
Aug 12, 2016	SUPPL -2	View Letter (PDF)
Nov 13, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 40MG BASE

RLD

5 patents3 exclusivities▴

TABLET;ORAL | Approved: Nov 13, 2015

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8946235	Aug 8, 2032	—	Yes	Yes		—
9732058	Jul 25, 2032	—	Yes	Yes		—
10183020	Jan 2, 2035	—	—	Yes		—
11524951	Jul 25, 2032	—	Yes	Yes	—	—
12465608	Nov 26, 2042	—	—	—		—

Exclusivities (3)

Code	Date	Status
I-941	Feb 16, 2027	< 1 year
I-952	Sep 25, 2027	Active
ODE-337	Dec 18, 2027	Active

#002 — EQ 80MG BASE

RLD

5 patents3 exclusivities▾

TABLET;ORAL | Approved: Nov 13, 2015