Viewing data from:

TUKYSA

NDA

TUCATINIB | N213411 | SEAGEN INC

2 strengths7 unique patents3 unique exclusivities

Patent Timeline

7 unique patents, 3 exclusivities by expiration date

Expiring < 1yr (1)Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

Apr. 17, 2034

Oct. 12, 2032

May. 9, 2027

Apr. 27, 2038

Mar. 25, 2033

Apr. 27, 2038

Apr. 27, 2038

I-906

Jan. 19, 2026

ODE-309

Apr. 17, 2027

ODE-422

Jan. 19, 2030

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib NCT05323955	Phase 2	Active	Carey Anders, M.D.	48	2023-03-23 → 2027-11
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors NCT06157892	Phase 2	Active	Seagen, a wholly owned subsidiary of Pfizer	54	2024-05-20 → 2029-07-28

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

Medicare Part D Spending

CMS annual spending data for Tukysa (2023)

Total Spending

$102.4M

Total Claims

4,891

Beneficiaries

936

Avg Cost/Unit

$191.93

Spending Trend

$30.7M(2020)→$81.6M(2021)→$91.2M(2022)→$102.4M(2023)

YoY Change:+9.6%

5yr CAGR:+8.4%

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

API Supply Chain6 active DMFs

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

TEVA PHARMACEUTICAL INDUSTRIES LTDTUCATINIB

DMF 390572023

MSN LABORATORIES PRIVATE LTDTUCATINIB HEMIETHANOLATE

DMF 394502024

SCINOPHARM TAIWAN LTDTUCATINIB

DMF 412242025

DR REDDYS LABORATORIES LTDTUCATINIB

DMF 414532025

DR REDDYS LABORATORIES LTDTUCATINIB HEMIETHANOLATE

DMF 414542025

DR REDDYS LABORATORIES LTDTUCATINIB COPOVIDONE ASD

DMF 423362025

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 20, 2023	SUPPL -4	View Letter (PDF)
Apr 20, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG

RLD

7 patents3 exclusivities▴

TABLET;ORAL | Approved: Apr 17, 2020

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8648087	Apr 17, 2034	—	Yes	Yes	—	—
9457093	Oct 12, 2032	—	—	Yes		—
9693989	May 9, 2027	—	—	Yes		—
11207324	Apr 27, 2038	—	—	—		—
11504370	Mar 25, 2033	—	—	—		—
11666572	Apr 27, 2038	—	—	—		—
12048698	Apr 27, 2038	—	—	—		—

Exclusivities (3)

Code	Date	Status
I-906	Jan 19, 2026	Expired
ODE-309	Apr 17, 2027	< 1 year
ODE-422	Jan 19, 2030	Active

#002 — 150MG

RLD

7 patents3 exclusivities▾

TABLET;ORAL | Approved: Apr 17, 2020