Viewing data from:

VERSACLOZ

NDA

CLOZAPINE | N203479 | DOUGLAS PHARMACEUTICALS AMERICA LTD

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

8057811

May. 1, 2028

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 Versacloz (2023)

Total Spending

$1.3M

Total Claims

842

Beneficiaries

Avg Cost/Unit

$8.84

Spending Trend

$496K(2019)→$798K(2020)→$1.0M(2021)→$1.2M(2022)→$1.3M(2023)

YoY Change:+3.0%

5yr CAGR:+2.5%

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

API Supply Chain12 active DMFs3 inactive

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

MEDICHEM SACLOZAPINE

DMF 105341993

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDCLOZAPINE

DMF 111951994

CAMBREX PROFARMACO MILANO SRLCLOZAPINE

DMF 116921995

WUHAN SHIJI PHARMACEUTICAL CO LTDCLOZAPINE

DMF 198222006

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDCLOZAPINE

DMF 251822011

MATRIX PHARMACORP PRIVATE LTDCLOZAPINE USP

DMF 273792013

COHANCE LIFESCIENCES LTDCLOZAPINE USP

DMF 319992017

AURORE LIFE SCIENCES PRIVATE LTDCLOZAPINE USP

DMF 366452021

GLOBAL CALCIUM PRIVATE LTDCLOZAPINE USP

DMF 368692022

MANKIND PHARMA LTDCLOZAPINE USP

DMF 375402023

R L FINE CHEM PVT LTDCLOZAPINE

DMF 380712023

SMS PHARMACEUTICALS LTDCLOZAPINE USP

DMF 399132024

AREVIPHARMA GMBHInactiveCLOZAPINE

DMF 108621994

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveCLOZAPINE

DMF 110981994

SELOC FRANCEInactiveCLOZAPINE

DMF 124011997

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Jun 16, 2025	SUPPL -26	View Letter (PDF)
Feb 6, 2025	SUPPL -22	View Letter (PDF)
Apr 27, 2023	SUPPL -21	View Letter (PDF)
Nov 12, 2021	SUPPL -17	View Letter (PDF)
Aug 2, 2021	SUPPL -16	View Letter (PDF)
Feb 22, 2021	SUPPL -15	View Letter (PDF)
Jul 30, 2020	SUPPL -12	View Letter (PDF)
Apr 15, 2020	SUPPL -14	View Letter (PDF)
Jan 22, 2019	SUPPL -11	View Letter (PDF)
Mar 2, 2017	SUPPL -10	View Letter (PDF)
Oct 2, 2015	SUPPL -9	View Letter (PDF)
Sep 17, 2015	SUPPL -7	View Letter (PDF)
Sep 17, 2015	SUPPL -8	View Letter (PDF)
Dec 9, 2013	SUPPL -1	View Letter (PDF)
Aug 23, 2013	SUPPL -2	View Letter (PDF)
Feb 8, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML

RLD

1 patent0 exclusivities▴

SUSPENSION;ORAL | Approved: Feb 6, 2013

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8057811	May 1, 2028	—	—	Yes	—	—