Viewing data from:

SYMPAZAN

NDA

CLOBAZAM | N210833 | ASSERTIO SPECIALTY PHARMACEUTICALS LLC

3 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

11541002

Jan. 31, 2040

12290597

Sep. 5, 2039

12403090

Sep. 5, 2039

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 Sympazan (2023)

Total Spending

$2.5M

Total Claims

1,350

Beneficiaries

183

Avg Cost/Unit

$36.96

Spending Trend

$432K(2019)→$1.2M(2020)→$1.6M(2021)→$2.2M(2022)→$2.5M(2023)

YoY Change:+0.3%

5yr CAGR:+7.9%

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

API Supply Chain9 active DMFs1 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

EUROAPI GERMANY GMBHCLOBAZAM

DMF 183402005

FIS FABBRICA ITALIANA SINTETICI SPACLOBAZAM

DMF 247282011

CAMBREX PROFARMACO MILANO SRLCLOBAZAM

DMF 290612015

PIRAMAL PHARMA LTDCLOBAZAM

DMF 291642015

HONOUR LAB LTDCLOBAZAM

DMF 293512015

CENTAUR PHARMACEUTICALS PRIVATE LTDCLOBAZAM USP

DMF 294072015

RAKS PHARMA PVT LTDCLOBAZAM

DMF 305402016

MSN LIFE SCIENCES PRIVATE LTDCLOBAZAM

DMF 308752016

MICRO LABS LTDCLOBAZAM

DMF 320592017

FIS FABBRICA ITALIANA SINTETICI SPAInactiveCLOBAZAM

DMF 180802005

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 13, 2024	SUPPL -6	View Letter (PDF)
Jan 17, 2023	SUPPL -4	View Letter (PDF)
Mar 17, 2021	SUPPL -2	View Letter (PDF)
Feb 9, 2021	SUPPL -3	View Letter (PDF)
Dec 10, 2020	SUPPL -1	View Letter (PDF)
Nov 6, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG

RLD

3 patents0 exclusivities▴

FILM;ORAL | Approved: Nov 1, 2018

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
11541002	Jan 31, 2040	—	—	Yes	—
12290597	Sep 5, 2039	—	—	Yes	—
12403090	Sep 5, 2039	—	—	Yes	—

#002 — 10MG

RLD

3 patents0 exclusivities▾

FILM;ORAL | Approved: Nov 1, 2018

#003 — 20MG

RLD

1 patent0 exclusivities▾

FILM;ORAL | Approved: Nov 1, 2018