Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2018-00739	9364435	IPR	Moderna Therapeutics, Inc.	Final Written Decision	2018-03-05	—
IPR2019-00554	8058069	IPR	Moderna Therapeutics, Inc.	Final Written Decision	2019-01-09	—

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 Onpattro (2023)

Total Spending

$9.2M

Total Claims

305

Beneficiaries

Avg Cost/Unit

$2024.07

Spending Trend

$2.1M(2019)→$5.6M(2020)→$11.4M(2021)→$16.4M(2022)→$9.2M(2023)

YoY Change:+2.3%

5yr CAGR:+1.4%

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

Medicare Part B Spending

CMS physician-administered drug spending for Onpattro (2023)

Total Spending

$37.7M

Total Claims

1,458

Beneficiaries

174

ASP Price

—

HCPCS: J0222 — Injection, patisiran, 0.1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE/5ML (EQ 2MG BASE/ML)

RLD

13 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: Aug 10, 2018

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8058069	Apr 15, 2029	—	—	Yes	—	—
8158601	Nov 10, 2030	—	—	Yes		—
8168775	Aug 10, 2032	—	Yes	Yes		—
8492359	Apr 15, 2029	—	—	Yes	—	—
8642076	Oct 3, 2027	—	—	Yes	—	—
8741866	Oct 20, 2029	—	—	—		—
8802644	Oct 21, 2030	—	—	Yes		—
8822668	Apr 15, 2029	—	—	Yes		—
9234196	Oct 20, 2029	—	—	Yes		—
9364435	Apr 15, 2029	—	—	Yes		—
10240152	Oct 20, 2029	—	Yes	Yes		—
11079379	Aug 27, 2035	—	Yes	Yes		—
11141378	Apr 15, 2029	—	—	Yes	—	—

Code	Date	Status
M-270	Jan 13, 2026	Expired