Viewing data from:

RELYVRIO

NDA

SODIUM PHENYLBUTYRATE; TAURURSODIOL | N216660 | AMYLYX PHARMACEUTICALS INC

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Dec. 24, 2033

Dec. 24, 2033

Dec. 24, 2033

Dec. 24, 2033

Jul. 27, 2040

NCE

Sep. 29, 2027

ODE-411

Sep. 29, 2029

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 Relyvrio (2023)

Total Spending

$197.6M

Total Claims

15,807

Beneficiaries

3,319

Avg Cost/Unit

$234.90

Spending Trend

$9.9M(2022)→$197.6M(2023)

YoY Change:-0.3%

5yr CAGR:-0.3%

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 29, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3GM/PACKET; 1GM/PACKET

RLD

5 patents2 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Sep 29, 2022

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9872865	Dec 24, 2033	—	—	—		—
10251896	Dec 24, 2033	—	—	—		—
10857162	Dec 24, 2033	—	—	—		—
11071742	Dec 24, 2033	—	—	Yes	—	—
11583542	Jul 27, 2040	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
NCE	Sep 29, 2027	Active
ODE-411	Sep 29, 2029	Active