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TEGSEDI

NDA

INOTERSEN SODIUM | N211172 | AKCEA THERAPEUTICS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

Today

8697860

Apr. 29, 2031

9061044

Apr. 29, 2031

9399774

Apr. 29, 2031

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tegsedi (2023)

Total Spending

$6.3M

Total Claims

161

Beneficiaries

Avg Cost/Unit

$6565.00

Spending Trend

$19.2M(2019)→$23.6M(2020)→$19.2M(2021)→$14.7M(2022)→$6.3M(2023)

YoY Change:+1.7%

5yr CAGR:+2.3%

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Nov 26, 2024	SUPPL -15	View Letter (PDF)
Jan 16, 2024	SUPPL -14	View Letter (PDF)
Mar 9, 2023	SUPPL -12	View Letter (PDF)
Jun 23, 2022	SUPPL -10	View Letter (PDF)
Apr 4, 2022	SUPPL -11	View Letter (PDF)
Jul 31, 2020	SUPPL -8	View Letter (PDF)
May 13, 2020	SUPPL -6	View Letter (PDF)
Oct 29, 2019	SUPPL -4	View Letter (PDF)
Oct 11, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)

RLD

3 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Oct 5, 2018

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8697860	Apr 29, 2031	—	—	Yes	—	—
9061044	Apr 29, 2031	—	Yes	—	—	—
9399774	Apr 29, 2031	—	—	—		—