Viewing data from:

SOTYLIZE

NDA

SOTALOL HYDROCHLORIDE | N205108 | AZURITY PHARMACEUTICALS INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Aug. 31, 2035

Apr. 1, 2034

Apr. 1, 2034

Nov. 19, 2034

Apr. 1, 2034

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 Sotylize (2023)

Total Spending

$18K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$1.96

Spending Trend

$45K(2019)→$28K(2020)→$57K(2021)→$45K(2022)→$18K(2023)

YoY Change:-1.1%

5yr CAGR:+3.9%

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

API Supply Chain2 active DMFs5 inactive

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

SIEGFRIED LTDSOTALOL HYDROCHLORIDE

DMF 37211980

NEULAND LABORATORIES LTDSOTALOL HYDROCHLORIDE USP

DMF 149512000

IROTEC LABORATORIESInactiveSOTALOL HYDROCHLORIDE

DMF 118871996

ERREGIERRE SPAInactiveSOTALOL HYDROCHLORIDE

DMF 130831998

HEUMANN PHARMA GMBHInactiveSOTALOL HYDROCHLORIDE

DMF 131861998

SIFAVITOR SRLInactiveSOTALOL HYDROCHLORIDE

DMF 148412000

AREVIPHARMA GMBHInactiveSOTALOL HYDROCHLORIDE

DMF 237522010

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 16, 2024	SUPPL -3	View Letter (PDF)
Dec 18, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/ML (5MG/ML)

RLD

5 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Oct 22, 2014

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9724297	Aug 31, 2035	—	—	Yes		—
10206895	Apr 1, 2034	—	—	Yes		—
11013703	Apr 1, 2034	—	—	Yes	—	—
11850222	Nov 19, 2034	—	—	—		—
12290495	Apr 1, 2034	—	—	—		—