Viewing data from:

AMVUTTRA

NDA

VUTRISIRAN SODIUM | N215515 | ALNYLAM PHARMACEUTICALS INC

1 strength13 unique patents4 unique exclusivities

Patent Timeline

13 unique patents, 4 exclusivities by expiration date

Active (13)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Dec. 12, 2029

Dec. 4, 2028

Dec. 4, 2028

Nov. 16, 2032

Aug. 24, 2028

Jul. 28, 2036

Nov. 16, 2032

Aug. 14, 2035

Jul. 28, 2036

Dec. 4, 2028

Jul. 28, 2036

Aug. 14, 2035

Jul. 28, 2036

NCE

Jun. 13, 2027

I-964

Mar. 20, 2028

ODE-212

Jun. 13, 2029

ODE-527

Mar. 20, 2032

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Alnylam Pharmaceuticals, Inc. FDA-2026-P-7229 · 10 docket documents Alnylam Pharmaceuticals, the sponsor of NDA 215515 for AMVUTTRA (vutrisiran) injection, filed this petition pursuant to Section 505 requesting that the FDA decline approval of any abbreviated new drug application under Section 505(j) or Section 505(b)(2) application referencing AMVUTTRA unless appli	505(q)	2026-06-30	Open	Alnylam Pharmaceuticals, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy NCT04153149	Phase 3	Active	Alnylam Pharmaceuticals	655	2019-11-26 → 2026-12-02

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$89238.08

Highest Price

$117551.74

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71336-1003-01AMVUTTRA 25MG/0.5ML SYRINGE	$117551.74	FSS	Alnylam Pharmaceuticals, Inc.	08/31/2026
71336-1003-01AMVUTTRA 25MG/0.5ML SYRINGE	$89238.08	Big4	Alnylam Pharmaceuticals, Inc.	08/31/2026

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

Medicare Part D Spending

CMS annual spending data for Amvuttra (2024)

Total Spending

$140.9M

Total Claims

1,192

Beneficiaries

409

Avg Cost/Unit

$236450.75

Spending Trend

$11.4M(2022)→$67.4M(2023)→$140.9M(2024)

YoY Change:-1.4%

5yr CAGR:+0.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Amvuttra (2024)

Total Spending

$229.0M

Total Claims

3,103

Beneficiaries

603

ASP Price

$4935.18

Spending Trend

$167.4M(2023)→$229.0M(2024)

YoY Change:+0.7%

5yr CAGR:+0.7%

HCPCS: J0225 — Injection, vutrisiran, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

YANGZHOU AURISCO PHARMACEUTICAL CO LTDVUTRISIRAN SODIUM

DMF 437442026

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 24, 2025	SUPPL -6	View Letter (PDF)
Mar 13, 2025	SUPPL -5	View Letter (PDF)
Feb 17, 2023	SUPPL -2	View Letter (PDF)
Jun 14, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

RLD

13 patents4 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Jun 13, 2022

Patents (13) · 12 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8106022	Dec 12, 2029	—	Yes	Yes		—
8828956	Dec 4, 2028	—	Yes	Yes		—
9370581	Dec 4, 2028	—	Yes	Yes		—
9399775	Nov 16, 2032	—	Yes	Yes		—
10131907	Aug 24, 2028	—	Yes	Yes		—
10208307	Jul 28, 2036	—	Yes	Yes		—
10570391	Nov 16, 2032	—	Yes	Yes		—
10612024	Aug 14, 2035	—	Yes	Yes		—
10683501	Jul 28, 2036	—	Yes	Yes		—
10806791	Dec 4, 2028	—	Yes	—	—	—
11286486	Jul 28, 2036	—	Yes	Yes		—
11401517	Aug 14, 2035	—	Yes	Yes		—
12049628	Jul 28, 2036	—	Yes	Yes		—

Exclusivities (4)

Code	Date	Status
I-964	Mar 20, 2028	Active
NCE	Jun 13, 2027	< 1 year
ODE-212	Jun 13, 2029	Active
ODE-527	Mar 20, 2032	Active