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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

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

4 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. Alembic Pharmaceuticals Limited 1:2021cv00982	D. Del.	2021-07-02	Terminated 2022-04-25	—
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	—
AstraZeneca AB et al v. Alembic Pharmaceuticals Limited 1:2020cv00202	D. Del.	2020-02-11	Terminated 2022-04-25	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

12 trials from ClinicalTrials.gov — 3 recruiting, 4 active, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer NCT06498986	Phase 2	Active	Sichuan Baili Pharmaceutical Co., Ltd.	76	2024-07-31 → 2027-06
Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC NCT04141644	Phase 1	Active	University of Utah	24	2020-08-20 → 2028-04-30
Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases NCT02971501	Phase 2	Active	National Cancer Institute (NCI)	5	2018-06-27 → 2026-07-01
A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients NCT04001777	Phase 1	Active	Ascentage Pharma Group Inc.	80	2019-07-04 → 2026-06
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)NCT07079475	Phase 1/2	Recruiting	Dizal Pharmaceuticals	220	2025-07-30 → 2028-12
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer NCT04181060	Phase 3	Recruiting	National Cancer Institute (NCI)	300	2020-12-28 → 2026-12-31
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer NCT07153055	Phase 1/2	Recruiting	Misty Shields	16	2027-01 → 2029-10
Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer NCT03810807	Phase 1	Completed	Memorial Sloan Kettering Cancer Center	22	2019-01-17 → 2025-12-15
TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy NCT03394118	Phase 2	Completed	Asan Medical Center	63	2017-08-11 → 2021-04-08
AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer NCT02151981	Phase 3	Completed	AstraZeneca	421	2014-08-04 → 2023-12-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$12896.31

Highest Price

$15448.60

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00310-1349-30TAGRISSO 40MG TAB	$12896.31	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-1349-30TAGRISSO 40MG TAB	$15448.60	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-1350-30TAGRISSO 80MG TAB	$12969.91	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-1350-30TAGRISSO 80MG TAB	$15448.60	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Tagrisso (2024)

Total Spending

$1.6B

Total Claims

96,403

Beneficiaries

12,370

Avg Cost/Unit

$553.43

Spending Trend

$640.7M(2019)→$793.5M(2020)→$913.3M(2021)→$1.1B(2022)→$1.2B(2023)→$1.6B(2024)

YoY Change:-2.8%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2024). 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

24 letters from Drugs@FDA

Date	Submission	Document
Sep 15, 2026	SUPPL -35	View Letter (PDF)
Sep 15, 2026	SUPPL -36	View Letter (PDF)
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 -8	View Letter (PDF)
Apr 23, 2018	SUPPL -9	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

17 patents3 exclusivities▴

TABLET;ORAL | Approved: Nov 13, 2015

Patents (17)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8946235	Aug 8, 2032	—	Yes	Yes		—
8946235	Aug 8, 2032	—	Yes	Yes		—
8946235	Aug 8, 2032	—	Yes	Yes		—
8946235	Aug 8, 2032	—	Yes	Yes		—
8946235	Aug 8, 2032	—	Yes	Yes		—
9732058	Jul 25, 2032	—	Yes	Yes		—
9732058	Jul 25, 2032	—	Yes	Yes		—
9732058	Jul 25, 2032	—	Yes	Yes		—
9732058	Jul 25, 2032	—	Yes	Yes		—
9732058	Jul 25, 2032	—	Yes	Yes		—
10183020	Jan 2, 2035	—	—	Yes		—
10183020	Jan 2, 2035	—	—	Yes		—
10183020	Jan 2, 2035	—	—	Yes		—
10183020	Jan 2, 2035	—	—	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	< 1 year
ODE-337	Dec 18, 2027	Active

#002 — EQ 80MG BASE

RLD

17 patents3 exclusivities▾

TABLET;ORAL | Approved: Nov 13, 2015